1
|
He X, Pu Y, Li Z, Huan S, Yang Y. The global regulatory landscape for combined vaccines: A comparative case study of registration strategies for diphtheria-tetanus-pertussis-containing vaccines. Vaccine 2025; 54:127017. [PMID: 40179521 DOI: 10.1016/j.vaccine.2025.127017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2024] [Revised: 03/04/2025] [Accepted: 03/08/2025] [Indexed: 04/05/2025]
Abstract
Diphtheria-tetanus-pertussis-containing vaccines (DTPCVs) represent the forefront of combination vaccine development globally. However, the licensing of high-valent DTPCVs varies worldwide owing to diverse regulatory requirements. Some national regulatory authorities (NRAs) have adopted flexible strategies to fast-track the approval and uptake of critical DTPCVs to address public health needs. This study examined the global regulatory status of combination vaccines, using descriptive and comparative analyses to highlight pivotal registration issues for DTPCVs. Specifically, it sheds light on the regulatory approaches of the Food and Drug Administration (FDA), European Medicines Agency (EMA), National Medical Products Administration (NMPA), and other Asian regulators through a case study of hepatitis B-containing DTPCVs. Drawing on these findings, this study advocates the initiation of regulatory convergence efforts, establishment of practical regulatory strategies, and swift approval and wider adoption of high-valent DTPCVs.
Collapse
Affiliation(s)
- Xiangchuan He
- School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China; The Scientific and Technological Achievement Transformation Center, Beijing Youan Hospital, Capital Medical University, Beijing, 100069, China
| | - Yiwen Pu
- School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China
| | - Zeyu Li
- School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China
| | - Shitong Huan
- China office, The Bill & Melinda Gates Foundation, Beijing, 100084, China.
| | - Yue Yang
- School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China.
| |
Collapse
|
2
|
Erdoğdu Hİ, Bozlak ÇEB, Başak M, Başar SK, Topaloğlu İ, Tural K. Anti-HBs Levels 18-26 Years After the Initial Hepatitis B Vaccination Series in a Low-to-Medium Prevalence Region: Is a Booster Dose or a Second Vaccine Series Necessary? Curr Microbiol 2025; 82:223. [PMID: 40169411 DOI: 10.1007/s00284-025-04211-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2024] [Accepted: 03/22/2025] [Indexed: 04/03/2025]
Abstract
This cross-sectional study aimed to evaluate the persistence of immunity provided by hepatitis B (Hep B) vaccine 18-26 years after primary vaccination among 628 participants. Blood samples were collected for Hep B surface antigen (HBsAg), anti-HBs antibody (anti-HBs), and core antibody (anti-HBc) analyses. For participants with anti-HBs levels of < 10 mIU/mL, booster dose was administered and anti-HBs titers were monitored 4-6 weeks after vaccination was completed. If the response to Hep B vaccine was inadequate, two additional Hep B vaccine doses were administered. Of the 628 participants, 269 were excluded based on the exclusion criteria, and 359 were included in the final analysis. Three participants were found to be HBsAg-positive, resulting in an HBsAg carrier rate of 0.83%. Moreover, 55.4% participants had anti-HBs levels of ≥ 10 mIU/mL, with a geometric mean concentration (GMC) of 82.59 mIU/mL (95% confidence interval [CI]). Among 125 participants with anti-HBs levels of < 10 mIU/mL, 93.1% reached anti-HBs levels of ≥ 10 mIU/mL after booster dose, with a GMC of 493.47 mIU/mL. A prebooster anti-HBs cutoff level of 1.28 mIU/mL was predictive for an immune response, with a sensitivity and specificity of 71.2% and 71.4%, respectively (p = 0.001, 95% CI, likelihood ratio: 2.49). Among 14 participants unresponsive to the booster dose, 78.5% responded to the second vaccine series with a GMC of 670.82 mIU/mL. Approximately 44.6% of participants required a booster dose 18-26 years after primary vaccination. Prebooster anti-HBs titration may predict the response to booster doses. Further studies with larger groups are needed to confirm these findings.
Collapse
Affiliation(s)
- Halil İbrahim Erdoğdu
- Department of Internal Medicine, Health Research Center, Kafkas University, Kars, Turkey.
| | | | | | | | - İhsan Topaloğlu
- Department of Chest Diseases, Health Research Center, Kafkas University, Kars, Turkey
| | - Kevser Tural
- Department of Thoracic Cardiovascular Surgery, Health ScıEnces University Mehmet Akif Ersoy Hospital, Istanbul, Turkey
| |
Collapse
|
3
|
Caldera F, Kane S, Long M, Hashash JG. AGA Clinical Practice Update on Noncolorectal Cancer Screening and Vaccinations in Patients With Inflammatory Bowel Disease: Expert Review. Clin Gastroenterol Hepatol 2025; 23:695-706. [PMID: 39800200 DOI: 10.1016/j.cgh.2024.12.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2024] [Revised: 12/15/2024] [Accepted: 12/18/2024] [Indexed: 01/15/2025]
Abstract
DESCRIPTION The aim of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to provide Best Practice Advice statements for gastroenterologists and other healthcare providers who provide care to patients with inflammatory bowel disease (IBD). The focus is on IBD-specific screenings (excluding colorectal cancer screening, which is discussed separately) and vaccinations. We provide guidance to ensure that patients are up to date with the disease-specific cancer screenings and vaccinations, as well as advice for mental health and general well-being. METHODS This expert review was commissioned and approved by the AGA CPU Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPU Committee and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. The Best Practice Advice statements were drawn from reviewing existing literature combined with expert opinion to provide practical advice on the screening for noncolorectal cancers and vaccinations in patients with IBD. Because this was not a systematic review, formal rating of the quality of evidence or strength of the presented considerations was not performed. Best Practice Advice Statements BEST PRACTICE ADVICE 1: All adult patients with IBD should receive age-appropriate cancer screening. BEST PRACTICE ADVICE 2: Adult women with IBD should follow age-appropriate screening for cervical dysplasia. Data are insufficient to determine whether patients receiving combined immunosuppression or thiopurines require more frequent screening. Shared decision making and individual risk stratification are encouraged. BEST PRACTICE ADVICE 3: All adult patients with IBD should follow skin cancer primary prevention practices by avoiding excessive exposure to the sun's ultraviolet radiation. Patients on immunomodulators, anti-tumor necrosis factor biologic agents, or small molecules should undergo yearly total body skin exam. Patients with any history of thiopurine use should continue with yearly total body skin exam even after thiopurine cessation. BEST PRACTICE ADVICE 4: At every colonoscopy, a thorough perianal and anal examination should be performed. Special attention should be made to inspection of the anal canal of patients with perianal Crohn's disease, with anal stricture, with human papillomavirus, with human immunodeficiency virus, and who engage in anoreceptive intercourse. BEST PRACTICE ADVICE 5: Gastroenterology clinicians should discuss age-appropriate vaccines with adult patients who have IBD and share responsibility with primary care providers for administering these vaccines. Patients with IBD should follow the adult immunization schedule advised by the Centers for Disease Control and Prevention (CDC) for all vaccines with the exception of live vaccines; Patients receiving immune-modifying agents should be counseled against receiving live vaccines; Immunization history to the 2 live pediatric vaccines, varicella and measles, mumps, and rubella vaccine series, is presumptive evidence of immunity. All adults 18 to 26 years of age should receive human papillomavirus vaccine series, and those between 27 and 45 of age years should be vaccinated if they are likely to have a new sexual partner. BEST PRACTICE ADVICE 6: Inactivated vaccines are safe in patients with IBD, and their administration is not associated with exacerbation of IBD activity. We suggest that patients receive vaccines at the earliest opportunity and preferably be off corticosteroids or at the lowest tolerable corticosteroid dose. BEST PRACTICE ADVICE 7: All adult patients with IBD should be evaluated for latent hepatitis B infection. Patients who have previously completed a full hepatitis B vaccine series but are not seroprotected (hepatitis B surface antibody [anti-HBs] <10 mIU/mL) should receive a single challenge dose of hepatitis B vaccine; Four to 8 weeks after this challenge dose, their anti-HBs levels should be measured to evaluate for an amnestic response. An amnestic response, indicated by an anti-HBs level ≥10 mIU/mL (seroprotection), suggests immunologic memory, and no further doses are needed. If no amnestic response is observed, the patient should complete a second full 2- or 3-dose series of hepatitis B vaccination. BEST PRACTICE ADVICE 8: All adult patients with IBD should receive an annual inactivated influenza vaccine. Patients receiving anti-tumor necrosis factor monotherapy or who have undergone a solid organ transplant recipients can benefit from a high-dose influenza vaccine. Adults 65 years of age and older should receive a high-dose, recombinant, or adjuvanted influenza vaccine. Live attenuated intranasal vaccines should be avoided. BEST PRACTICE ADVICE 9: All adult patients with IBD 19 to 64 years of age should receive an initial pneumococcal vaccine, with an subsequent second pneumococcal vaccine administered at 65 years of age and older. BEST PRACTICE ADVICE 10: All adult patients with IBD who are 60 years of age and older should receive a respiratory syncytial virus vaccine. There is no preference for any of the available respiratory syncytial virus vaccines. BEST PRACTICE ADVICE 11: All adult patients 19 years of age and older receiving immune-modifying therapies, or with plans to initiate immune-modifying therapies, should receive a recombinant herpes zoster vaccine series, regardless of their prior varicella vaccination status. BEST PRACTICE ADVICE 12: Bone densitometry should be considered in patients with IBD, regardless of age, when risk factors for osteopenia and osteoporosis are present. These risk factors include low body mass index (<20 kg/m2), >3 months of cumulative corticosteroid exposure, current smoking, postmenopausal status, or hypogonadism. In the absence of other factors, bone densitometry should be considered for postmenopausal women and men 65 years or older. BEST PRACTICE ADVICE 13: All adult patients with IBD should be screened for depression and anxiety annually. Patients who screen positive for depression or anxiety should be referred to the appropriate specialist, be it their primary care physician or a mental health specialist.
Collapse
Affiliation(s)
- Freddy Caldera
- Division of Gastroenterology and Hepatology, Department of Medicine, School of Medicine & Public Health, University of Wisconsin-Madison, Madison, Wisconsin.
| | - Sunanda Kane
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
| | - Millie Long
- Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina
| | - Jana G Hashash
- Inflammatory Bowel Disease Center, Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida.
| |
Collapse
|
4
|
Jayasekera CR, Rajasooriyar C, Richards C, Arora S, Borad MJ. Transforming Hepatocellular Carcinoma Treatment in Lower Income Countries. Mayo Clin Proc 2025; 100:605-608. [PMID: 40057864 DOI: 10.1016/j.mayocp.2024.12.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/25/2024] [Revised: 11/30/2024] [Accepted: 12/18/2024] [Indexed: 04/05/2025]
Affiliation(s)
- Channa R Jayasekera
- Liver Transplant Program, Mayo Clinic, Phoenix, AZ; Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ.
| | - Chrishanthi Rajasooriyar
- Teaching Hospital Jaffna, Jaffna, Sri Lanka; Tellipalai Trail Cancer Hospital, Jaffna, Sri Lanka
| | - Clayton Richards
- Cancer ECHO Initiative, Project ECHO; University of New Mexico Health Sciences Center, Albuquerque, NM
| | - Sanjeev Arora
- Cancer ECHO Initiative, Project ECHO; University of New Mexico Health Sciences Center, Albuquerque, NM
| | - Mitesh J Borad
- Liver and Biliary Cancer Research Program, Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ; Mayo Clinic Comprehensive Cancer Center, Phoenix, AZ
| |
Collapse
|
5
|
Sayan Kaya FB, Doğruyol AR, Öztürk H, Canbaz S, Ören Çelik MM. Vaccine hesitancy and acceptance among hemodialysis patients: a cross-sectional study in Turkey. BMC Public Health 2025; 25:1037. [PMID: 40098119 PMCID: PMC11917104 DOI: 10.1186/s12889-025-22206-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2025] [Accepted: 03/05/2025] [Indexed: 03/19/2025] Open
Abstract
BACKGROUND Vaccine hesitancy remains a significant issue threatening public health. The study aimed to determine the vaccination status of patients undergoing hemodialysis for chronic kidney disease and to analyze their levels of vaccine hesitancy. METHODS This cross-sectional analytical study was conducted in hemodialysis centers located in Ankara, the capital of Turkey. Data collection involved a structured questionnaire capturing sociodemographic details, comorbidities, vaccination history, and hesitancy levels, coupled with the Vaccine Hesitancy Scale (VHS), a 9-item tool validated in Turkish that measures trust in vaccines and perceived risks. RESULTS Among the 548 participants (mean age: 60.4 ± 12.9 years, range: 18-93; 57.8% male), 38.9% had a high school education or higher, and 52.7% reported income below their expenses. Despite 92.7% having received at least one vaccine during adulthood, knowledge about vaccines was limited, with only 7.7% answering all vaccine-related questions correctly. Influenza (73.4%) and hepatitis B (58.4%) were the most administered vaccines. The median VHS score was 32 (range: 11-45), with 84.7% scoring above 25, reflecting low overall hesitancy. Participants who identified physicians (76.6%) and healthcare workers (57.5%) as trusted sources of vaccine information tended to have lower hesitancy scores (p < 0.001). No significant associations were found between hesitancy and gender, education, income level, or general health perception. CONCLUSIONS While vaccination rates among hemodialysis patients are relatively high, critical gaps in knowledge persist, emphasizing the need for targeted educational programs. The active involvement of healthcare professionals is crucial to reduce hesitancy and enhance vaccine confidence in this vulnerable population.
Collapse
Affiliation(s)
| | - Ayşe Rumeysa Doğruyol
- Department of Public Health, Istanbul Faculty of Medicine, Istanbul University, Capa, Istanbul, 34390, Turkey
| | | | - Sevgi Canbaz
- Department of Public Health, Istanbul Faculty of Medicine, Istanbul University, Capa, Istanbul, 34390, Turkey
| | - Meryem Merve Ören Çelik
- Department of Public Health, Istanbul Faculty of Medicine, Istanbul University, Capa, Istanbul, 34390, Turkey.
| |
Collapse
|
6
|
Kimera A, Rujumba J, Ndikuno CK, Ndeezi G, Mukiza N, Basenero A, Piloya T, Bakeera-Kitaka S, Nabulya R, Nalumansi AM, Namagembe A, Bagala I, Namutosi A, Kobel E, Bazaali Z, Nansubuga C, Kinera I, Sekina H, Kitonsa JP, Kule I, Musiime V. Immune response and associated factors to Hepatitis B vaccination among children under five attending care at mulago hospital. BMC Pediatr 2025; 25:175. [PMID: 40057675 PMCID: PMC11889928 DOI: 10.1186/s12887-024-05366-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2024] [Accepted: 12/25/2024] [Indexed: 05/13/2025] Open
Abstract
BACKGROUND Hepatitis B is a major global health concern, with chronic infections affecting approximately 296 million people yearly. A 2009 survey in East Africa showed a prevalence rate of 6.5%, with Uganda's rate at 10.3% and Northern Uganda at 20.7%. Therefore, this study sought to determine the immune response to Hepatitis B vaccination and associated factors among children under five attending outpatient care at Mulago Assessment Centre Pediatrics clinic. METHODS A cross-sectional study involving 301 children aged 1 to under 5 years at Mulago National Referral's Pediatrics clinic was conducted in February 2023. Children were consecutively enrolled and screened for Hepatitis B core antibodies, with anti-HBs antibody titers measured. A pretested semi-structured questionnaire was administered to caregivers. Data analysis was conducted using STATA Version 13.0. Logistic regression analysis was done to determine factors associated with immune response, a binary outcome. RESULTS All 301 children tested negative for Hepatitis B core antibodies. Children's ages ranged between 1 and 4 years with most aged 2 years, 89/301(29.6%). The immune response varied from 2 IU/ml to 1000 IU/ml, with a median of 86.2 IU/ml (IQR: 14.5-239.4). The prevalence of good immune response was 77.4% (233/301) (95% CI: 72.3-81.8%), with 58.4% (95% CI: 51.9-64.6%) classified as very good responders. The factors associated with immune response were child age (aOR = 0.40; 95% CI: 0.16-0.97; p = 0.044) and caregiver HIV status (aOR = 0.17; 95% CI: 0.04-0.71; p = 0.014). CONCLUSION Children had protective antibody levels against the Hepatitis B virus, but it is still below the expected level by the World Health Organization. The child's age and caregiver's HIV status were associated with immune response. Emphasis needs to be made on the Hepatitis B birth dose and booster vaccinations, especially for children over 1 year and at-risk groups, to lower transmission rates and enhance long-term Hepatitis B protection.
Collapse
Affiliation(s)
- Andrew Kimera
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
| | - Joseph Rujumba
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | | | - Grace Ndeezi
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | | | - Andrew Basenero
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Theresa Piloya
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Sabrina Bakeera-Kitaka
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | | | | | - Agnes Namagembe
- USAID Maternal, Child Health, and Nutrition Activity, Washington, United States
| | - Irene Bagala
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Agatha Namutosi
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Esther Kobel
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Zakia Bazaali
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Caroline Nansubuga
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Irene Kinera
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Hassan Sekina
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - James Peter Kitonsa
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Isiah Kule
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| | - Victor Musiime
- Department of Pediatrics, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
| |
Collapse
|
7
|
Xie C, Zhou B, Yao D, Wang X, Zhong L, Qiu C, Zhang J. A cell-penetrating bispecific antibody suppresses hepatitis B virus replication and secretion. Virus Res 2025; 353:199531. [PMID: 39863173 PMCID: PMC11841211 DOI: 10.1016/j.virusres.2025.199531] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/09/2024] [Revised: 01/22/2025] [Accepted: 01/22/2025] [Indexed: 01/27/2025]
Abstract
Hepatitis B virus (HBV) represents one of the major pathogenic factor that leads to chronic liver diseases and the development of hepatocellular carcinoma (HCC). The currently approved anti-HBV drugs cannot eradicate the virus or block the development of HCC. HBV nucleocapsid consists of the hepatitis B core antigen (HBcAg) and the HBV relaxed-circular partially double-stranded DNA (rcDNA), indispensable in virus replication. The present study reported a cell-penetrating bispecific antibody targeting HBcAg and preS1, fused with the cell-penetrating peptide R9TAT, named Anti-preS1 × Anti-HBcAg-R9TAT. The antibody could recognize preS1 and HBcAg and internalize into living cells efficiently, suppressing the extracellular hepatitis B surface antigen (HBsAg) and hepatitis B envelope antigen, and the intracellular HBsAg and HBcAg in vitro. This cell-penetrating bispecific antibody is a novel approach to suppressing HBV replication and secretion and is a promising anti-HBV therapeutic antibody candidate.
Collapse
Affiliation(s)
- Chongwei Xie
- Medical Research Center, Yuebei People's Hospital, Shantou University Medical College, 512025, Shaoguan, China; Shenzhen Immuthy Biotech Co., Ltd, 518107, Shenzhen, Guangdong, China
| | - Bing Zhou
- Institute for Hepatology, National Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, The Second Affiliated Hospital, School of Medicine, Southern University of Science and Technology, 518112, Shenzhen, Guangdong, China
| | - Da Yao
- The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, 518037, Shenzhen, Guangdong, China
| | - Xin Wang
- Institute for Hepatology, National Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, The Second Affiliated Hospital, School of Medicine, Southern University of Science and Technology, 518112, Shenzhen, Guangdong, China
| | - Lihong Zhong
- The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, 518037, Shenzhen, Guangdong, China
| | - Chuanghua Qiu
- The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, 518037, Shenzhen, Guangdong, China.
| | - Junfang Zhang
- Medical Research Center, Yuebei People's Hospital, Shantou University Medical College, 512025, Shaoguan, China; Shenzhen Immuthy Biotech Co., Ltd, 518107, Shenzhen, Guangdong, China.
| |
Collapse
|
8
|
Zhou H, Yang J, Zhang J, Liu P, Yao D. A real-world pharmacovigilance analysis of hepatitis B vaccine using the U.S. Vaccine Adverse Event Reporting System (VAERS) database. Sci Rep 2025; 15:6022. [PMID: 39972053 PMCID: PMC11840001 DOI: 10.1038/s41598-025-90135-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2024] [Accepted: 02/11/2025] [Indexed: 02/21/2025] Open
Abstract
Hepatitis B vaccines (HBVs) are widely used duo to their high clinical use and mild effects. However, as post-marketing data accumulate, several serious adverse events (SAEs) following HBV have been reported. Currently, quantitative studies based on real-world data are lacking, and information on their adverse events is limited. Adverse reaction signals of the HBV were mined and analyzed using the U.S. Vaccine Adverse Event Reporting System (VAERS) to provide a reference for the safe clinical use of this vaccine. Multiple statistical methods, including the reporting odds ratio (ROR) method, the Medicines and Healthcare Products Regulatory Agency (MHRA) method, and the Bayesian Confidence Propagation Neural Network (BCPNN) method, were utilized to identify signals of HBV-associated adverse reactions, and positive signals consistent with designated medical events (DMEs) were singled out for focused comparison and discussion. Analysis of 54,136 HBV-related adverse events (AEs) identified 254 positive signals across 22 System Organ Classifications (SOCs), with General disorders and administration site conditions being the most common. Three potential positive new signals consistent with Preferred Terms (PTs) were identified in DME: Aplastic anaemia, Dermatitis exfoliative, and Haemolytic anaemia. This study suggests that HBV has a potential risk in terms of causing Aplastic anaemia, Dermatitis exfoliative, and Haemolytic anaemia. Some subtypes of Aplastic anaemia, Dermatitis exfoliative, Haemolytic anaemia are autoimmune diseases, and immunization may stimulate potential autoimmune genetic predisposition, people with autoimmune diseases or a family history of hereditary immune diseases should be monitored after receiving HBV. Health professionals should be contacted to take measures to help if anaemia, palpitations, and high fever occur.
Collapse
Affiliation(s)
- Huting Zhou
- School of Pharmacy, Nanjing Medical University, Nanjing, 211166, Jiangsu, China
| | - Jiale Yang
- School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, 211198, Jiangsu, China
| | - Jinbo Zhang
- School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, 211198, Jiangsu, China
| | - Pengcheng Liu
- School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, 211198, Jiangsu, China
| | - Dongning Yao
- School of Pharmacy, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.
| |
Collapse
|
9
|
Kar S, Verma D, Mehrotra S, Prajapati VK. Reconfiguring the immune system to target cancer: Therapies based on T cells, cytokines, and vaccines. ADVANCES IN PROTEIN CHEMISTRY AND STRUCTURAL BIOLOGY 2025; 144:77-150. [PMID: 39978976 DOI: 10.1016/bs.apcsb.2024.10.017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/22/2025]
Abstract
Over the years, extensive research has been dedicated to performing in-depth analysis of cancer to uncover the intricate details of its nature - including the types of cancer, causative agents, stimulators of disease progression, factors contributing to poor prognosis, and efficient therapies to restrict the metastatic aggressiveness. This chapter highlights the mechanisms through which different arms of the host immune system - namely cytokines, lymphocytes, antigen-presenting cells (APCs) -can be mobilized to eradicate cancer. Most malignant tumors are either poorly immunogenic, or are harbored in a highly immuno-suppressive microenvironment. This is why reinforcing the host's anti-tumor defenses, through infusion of pro-inflammatory cytokines, tumor antigen-loaded APCs, and anti-tumor cytotoxic cells has emerged as a viable treatment option against cancer. The chapter also highlights the ongoing preclinical and clinical studies in different malignancies and the outcome of various therapies. Although these methods are not foolproof, and antigen escape variants can still evade or develop resistance to customized therapies, they achieve disease stabilization in several cases when conventional treatments fail. In many instances, combination therapies involving cytokines, T cells, and vaccinations prove more effective than monotherapies. The limitations of the current therapies are also discussed, along with ongoing modifications aimed at improving efficacy.
Collapse
Affiliation(s)
- Sramona Kar
- Department of Biochemistry, University of Delhi South Campus, Benito Juarez Road, Dhaula Kuan, New Delhi, India
| | - Divya Verma
- Department of Biochemistry, University of Delhi South Campus, Benito Juarez Road, Dhaula Kuan, New Delhi, India
| | - Sanjana Mehrotra
- Department of Human Genetics, Guru Nanak Dev University, Amritsar, Punjab, India
| | - Vijay Kumar Prajapati
- Department of Biochemistry, University of Delhi South Campus, Benito Juarez Road, Dhaula Kuan, New Delhi, India.
| |
Collapse
|
10
|
Singh S, Mishra AK, Yachha M, Singh TP, Katiyar H, Kaul A, Dhiman RK, Bhadauria DS, Goel A. Seroprotection achieved with standard four-dose schedule of hepatitis B vaccine in people with chronic kidney disease: A real-life data. Indian J Gastroenterol 2025; 44:88-94. [PMID: 39298024 DOI: 10.1007/s12664-024-01685-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/19/2024] [Accepted: 08/24/2024] [Indexed: 09/21/2024]
Abstract
BACKGROUND AND OBJECTIVES Hepatitis B virus (HBV) infection is common in people with chronic kidney diseases (CKD). The guidelines recommend four doses, 2.0 mL each, of HBV vaccine, given at zero, one, two and six months in these patients. However, real-life data on the effectiveness of this schedule are limited. We retrospectively reviewed the HBV vaccine response in the CKD population. METHODS The study included adult (≥ 18 years) patients with glomerular filtration rate < 60 mL/min, if they had received four doses (each of 2.0 mL volume) of HBV vaccine and anti-HBs titer was measured at ≥ 1 month of the last dose of vaccine. Participants with hepatitis C or human immunodeficiency virus (HIV) coinfection, organ transplant recipients, active or remote malignancy or use of immunosuppressive medication were excluded. Anti-HBs antibody was measured with two different assays with their limits of detection up to 500 mIU/mL and 1000 mIU/mL. The presence of detectable anti-HBs antibody and anti-HBs titer ≥ 10 mIU/mL defined seroconversion and seroprotection, respectively. RESULTS The study included 208 patients (71.9% males; age 44 [33-55] years; CKD stage II/III/IV/V in 1.4%/7.2%/26.4%/64.9%; 46% on maintenance hemodialysis [MHD]). Overall, seroconversion and seroprotection were achieved in 174 (83.7%) and 161 (77.4%) participants and anti-HBs titer, measured three (2-8) months after the fourth dose, was 124 (12-500) mIU/mL. The median anti-HBs antibody levels at ≤ 6, 7-12, 13-24 and 24 months after the fourth doses were 116, 478, 43 and 70 mIU/mL, respectively. Age, body mass index, stage of CKD, serum albumin and dialysis status were not associated with seroprotection (p < 0.05). CONCLUSION A standard vaccination schedule of four 2.0 mL doses of HBV vaccine in CKD patients induces reasonably good and sustained seroprotection.
Collapse
Affiliation(s)
- Surender Singh
- Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Ajay Kumar Mishra
- Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Monika Yachha
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Thakur Prashant Singh
- Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Harshita Katiyar
- Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Anupma Kaul
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Radha Krishna Dhiman
- Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Dharmendra Singh Bhadauria
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India
| | - Amit Goel
- Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India.
| |
Collapse
|
11
|
Chien LN, Vargas-Zambrano JC, Ku MY. Decreasing hepatitis B seroprevalence in pregnant women in Taiwan between 2016 and 2021: a claim-based cohort study. BMC Public Health 2025; 25:111. [PMID: 39789546 PMCID: PMC11721186 DOI: 10.1186/s12889-025-21308-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/21/2024] [Accepted: 01/03/2025] [Indexed: 01/12/2025] Open
Abstract
BACKGROUND Hepatitis B virus (HBV) surface antigen (HBsAg) seroprevalence was high before the national vaccine policy was introduced in Taiwan, indicating significant HBV infection rates. The success of the HBV immunization program and other preventive measures likely led to decreased HBsAg prevalence among pregnant women. This study reports on the HBV seroprevalence among pregnant women in Taiwan from 2016 to 2021, including those potentially affected by the universal hepatitis B vaccination at birth. METHODS This claim-based cohort study included pregnant women with hospital-based prenatal HBV screening data: 162,662 for HBsAg and 161,729 for HBeAg, from 2016 to 2021. Patient medical records were reviewed to collect information on demographic characteristics and other health conditions. Logistic regression models were used to identify risk factors associated with HBsAg and HBV e antigen (HBeAg) positivity. RESULTS The seroprevalence for HBsAg and HBeAg during the study period was 4.0% and 0.6%, respectively. HBsAg positivity was highest among women born before July 1984 (pre-vaccination period; 8.6%), decreasing to 2.2% among those born between July 1986 and 1988 (national vaccination implementation) and further declining to 1.1% for those born after 1997. These data underscore the crucial role of large-scale immunization strategies in controlling HBV infections. Similarly, HBeAg positivity was highest among pregnant women born before the vaccination program (~ 1.0%), decreasing significantly to 0.4% for those born after 1989. The results showed geographic variations, potentially reflecting factors such as the mother's age and foreign nationality. However, the birth year was the most crucial factor associated with HBV marker positivity. CONCLUSIONS The implementation of national vaccination programs has demonstrated significant success in reducing HBV seroprevalence among pregnant women, which is particularly evident in the substantial decrease in HBsAg seroprevalence in Taiwan post-July 1986. These findings emphasize the importance of continued and consistent vaccination efforts, supporting the need for ongoing public health strategies to combat HBV infections effectively.
Collapse
Affiliation(s)
- Li-Nien Chien
- Institute of Health and Welfare Policy, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
| | | | - Meng-Yun Ku
- Graduate Institute of Data Science, College of Management, Taipei Medical University, Taipei, Taiwan
| |
Collapse
|
12
|
Machado-Alba JE, Machado-Duque ME, Gaviria-Mendoza A, Vargas-Zambrano JC. Timeliness for vaccination according to the expanded immunization program in children under 6 years of age in Colombia between 2014 and 2019. Hum Vaccin Immunother 2024; 20:2395685. [PMID: 39233398 PMCID: PMC11382698 DOI: 10.1080/21645515.2024.2395685] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2024] [Revised: 08/05/2024] [Accepted: 08/19/2024] [Indexed: 09/06/2024] Open
Abstract
The aim was to estimate the vaccination timeliness defined as the proportion of children under 6 years of age who received their immunization in the time range established by the Colombian Expanded Immunization Program (EIP). A retrospective cohort study that collected reports of vaccination opportunities between 2014 and 2019 provided by the Ministry of Health. Age, sex, city, ethnicity, health system affiliation regimen, vaccine applied, and timing of vaccination were considered for the time range under study. A total of 3,370,853 immunized children were included from all regions of the country. More than 80% of children had a timeliness to get most vaccines. The exceptions were yellow fever (17%) and seasonal influenza (42%). No differences in timeliness were found according to geographic region or by health system affiliation regime, but the average timeliness for all vaccines of children of the indigenous population (65.8% ±18.4%) was lower than that of the rest of the population (78·6% ± 19·3%) (p = 0·021). The timeliness for vaccination under the EIP of Colombia is high, with proportions of 72-96%, but intergroup differences were identified, mainly lower timeliness among indigenous people. These findings warrant improvement strategies that would guarantee the immunization of the entire child population.
Collapse
Affiliation(s)
- Jorge Enrique Machado-Alba
- Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma SA, Pereira, Colombia
| | - Manuel Enrique Machado-Duque
- Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma SA, Pereira, Colombia
- Grupo de Investigación Biomedicina, Facultad de Medicina, Fundación Universitaria Autónoma de las Américas, Pereira, Colombia
| | - Andrés Gaviria-Mendoza
- Grupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma SA, Pereira, Colombia
- Grupo de Investigación Biomedicina, Facultad de Medicina, Fundación Universitaria Autónoma de las Américas, Pereira, Colombia
| | | |
Collapse
|
13
|
Ibragimov R, Nabirova D, Denebaeva A, Kurbanov B, Horth R. Prevalence of hepatitis B surface antibody among previously vaccinated healthcare workers in Tashkent, Uzbekistan. Hum Vaccin Immunother 2024; 20:2435142. [PMID: 39693189 PMCID: PMC11789720 DOI: 10.1080/21645515.2024.2435142] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2024] [Revised: 11/13/2024] [Accepted: 11/23/2024] [Indexed: 12/20/2024] Open
Abstract
Healthcare workers (HCW) have high occupational risk for hepatitis B and Uzbekistan held two HCW vaccination campaigns in 2015 and 2022. Hepatitis B antibody testing (anti-HBs) after Hepatitis B (HepB) vaccination is recommended by the U.S. CDC and WHO for HCW, but Uzbekistan does not have such a policy. In 2023, we randomly selected HCW from the campaign registries. Participants who agreed were interviewed at their workplaces. Vaccination doses were self-reported. Testing for hepatitis B surface antigen (HBsAg), Total hepatitis B core antibody (anti-HBc), and anti-HBs were concurrently performed. We used multivariable Poisson regression to assess factors associated with anti-HBs ≥10 mIU/mL. Of 334 participants, 205 were vaccinated in 2015 and 129 in 2022. Median age was 40 years (interquartile range 35-49 years), and 87% were female. Most (71%) reported having completed the three doses, 21% two doses and 7% one dose. Testing revealed that 5% had an active HBV infection, 4% had a resolved infection, and 91% had detectable vaccine-derived antibodies. Among those (n = 303), 71% had anti-HBs ≥10 mIU/mL. For those who reported receiving 1, 2, and 3 doses, protective titers were 59%, 70%, and 72%, respectively. Protective titers were lower for HCW that worked in clinics versus hospitals (aPR = 0.92, CI: 0.87-0.98, p = .01) adjusting for age, dose number and presence of chronic conditions. Strategies to improve completion of the 3-dose series and policies for post-vaccination immunity testing 1-2 months after completion of the 3-dose HepB series could help identify workers who may require revaccination or are currently infected.
Collapse
Affiliation(s)
- Rafail Ibragimov
- Central Asia Field Epidemiology Training Program, Almaty, Kazakhstan
- Department of Medical and Preventive Care, Kazakh National Medical University Named After S. D. Asfendiyarov, Almaty, Kazakhstan
- Department of Scientific Research, Innovation, and Training, Committee for Sanitary and Epidemiological Welfare and Public Health under the Ministry of Health, Tashkent, Uzbekistan
| | - Dilyara Nabirova
- Central Asia Field Epidemiology Training Program, Almaty, Kazakhstan
- Department of Medical and Preventive Care, Kazakh National Medical University Named After S. D. Asfendiyarov, Almaty, Kazakhstan
- Division of Global Health Protection in Central Asia, United States Centers for Disease Control and Prevention, Almaty, Kazakhstan
| | - Alfiya Denebaeva
- Central Asia Field Epidemiology Training Program, Almaty, Kazakhstan
- AIDS Prevention and Control Center, Almaty, Kazakhstan
| | - Botirjon Kurbanov
- Central Asia Field Epidemiology Training Program, Almaty, Kazakhstan
- Department of Scientific Research, Innovation, and Training, Committee for Sanitary and Epidemiological Welfare and Public Health under the Ministry of Health, Tashkent, Uzbekistan
| | - Roberta Horth
- Central Asia Field Epidemiology Training Program, Almaty, Kazakhstan
- Department of Medical and Preventive Care, Kazakh National Medical University Named After S. D. Asfendiyarov, Almaty, Kazakhstan
- Division of Global Health Protection in Central Asia, United States Centers for Disease Control and Prevention, Almaty, Kazakhstan
| |
Collapse
|
14
|
Petrovsky N. Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine. Hum Vaccin Immunother 2024; 20:2363016. [PMID: 38839044 PMCID: PMC11155708 DOI: 10.1080/21645515.2024.2363016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2024] [Accepted: 05/29/2024] [Indexed: 06/07/2024] Open
Abstract
Recombinant protein vaccines represent a well-established, reliable and safe approach for pandemic vaccination. SpikoGen® is a recombinant spike protein trimer manufactured in insect cells and formulated with Advax-CpG55.2 adjuvant. In murine, hamster, ferret and non-human primate studies, SpikoGen® consistently provided protection against a range of SARS-CoV-2 variants. A pivotal Phase 3 placebo-controlled efficacy trial involving 16,876 participants confirmed the ability of SpikoGen® to prevent infection and severe disease caused by the virulent Delta strain. SpikoGen® subsequently received a marketing authorization from the Iranian FDA in early October 2021 for prevention of COVID-19 in adults. Following a successful pediatric study, its approval was extended to children 5 years and older. Eight million doses of SpikoGen® have been delivered, and a next-generation booster version is currently in development. This highlights the benefits of adjuvanted protein-based approaches which should not overlook when vaccine platforms are being selected for future pandemics.
Collapse
Affiliation(s)
- Nikolai Petrovsky
- Research Department, Australian Respiratory and Sleep Medicine Institute Ltd, Adelaide, Australia
- Research Department, Vaxine Pty Ltd, Warradale, Australia
| |
Collapse
|
15
|
Alves YM, Berra TZ, Tavares RBV, Zini N, Ferreira QR, Andrade LKDA, Tártaro AF, Pelodan MEP, Vigato BF, Silveira BK, Assumpção ALBNM, Popolin MAP, Curvo PA, Protti-Zanatta S, Serrano-Gallardo MDP, Arcêncio RA, Palha PF, Ballestero JGDA. Vaccination Coverage at Birth in Brazil: Spatial and Temporal Trends in the Impact of COVID-19 on Uptake of BCG and Hepatitis B Vaccines. Vaccines (Basel) 2024; 12:1434. [PMID: 39772094 PMCID: PMC11728551 DOI: 10.3390/vaccines12121434] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2024] [Revised: 12/03/2024] [Accepted: 12/11/2024] [Indexed: 01/16/2025] Open
Abstract
INTRODUCTION Vaccines are a significant public health achievement, which are crucial for child survival and disease control globally. In Brazil, the National Immunization Program (PNI) manages vaccination schedules, including essential vaccines like BCG and Hepatitis B, administered at birth. Despite achieving over 95% coverage for years, vaccination rates have declined since 2016, a trend exacerbated by the COVID-19 pandemic. This study aims to analyze spatial and temporal trends in BCG and Hepatitis B vaccination coverage at birth, identify areas with spatial variation in these trends, classify the identified trends, and investigate the pandemic's impact on vaccination adherence. METHODS This is an ecological study with real-world data from Brazil, focusing on vaccination coverage from 2014 to 2023. Utilizing the Spatial Variation in Temporal Trends (SVTT) technique, the study identifies municipalities' vaccination trends. It also employs time series analysis and Interrupted Time Series methods to evaluate the pandemic's impact on vaccination rates, using data from the PNI and the Information System on Live Births (SINASC). RESULTS Between January 2014 and December 2023, Brazil administered 25,902,207 doses of the BCG vaccine to children at birth, with 3911 municipalities (70.24%) showing declining trends, particularly in Florianópolis. Similarly, 22,962,434 doses of the Hepatitis B vaccine were administered, with 3284 municipalities also experiencing declines. CONCLUSIONS It is crucial that public health policies be reevaluated to address regional disparities in vaccination coverage, particularly in more vulnerable areas. Focused interventions, such as awareness campaigns, improved access to vaccination services, and strengthened monitoring, are fundamental to reversing this trend.
Collapse
Affiliation(s)
- Yan Mathias Alves
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Thaís Zamboni Berra
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Reginaldo Bazon Vaz Tavares
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Nathalia Zini
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Quézia Rosa Ferreira
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Licia Kellen de Almeida Andrade
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Ariela Fehr Tártaro
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Maria Eduarda Pagano Pelodan
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Beatriz Fornaziero Vigato
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Beatriz Kuroda Silveira
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Ana Luiza Brasileiro Nato Marques Assumpção
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | | | - Patricia Abrahão Curvo
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Simone Protti-Zanatta
- Nursing Department, Federal University of São Carlos, São Carlos 13565-905, São Paulo, Brazil;
| | | | - Ricardo Alexandre Arcêncio
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Pedro Fredemir Palha
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| | - Jaqueline Garcia de Almeida Ballestero
- Department of Maternal-Infant and Public Health Nursing, Ribeirão Preto College of Nursing, University of São Paulo, Ribeirão Preto 14040-902, São Paulo, Brazil; (T.Z.B.); (R.B.V.T.); (N.Z.); (Q.R.F.); (L.K.d.A.A.); (A.F.T.); (M.E.P.P.); (B.F.V.); (B.K.S.); (A.L.B.N.M.A.); (P.A.C.); (R.A.A.); (P.F.P.)
| |
Collapse
|
16
|
Yan B, Zhang X, Lv J, Feng Y, Meng X, Lin X, Zhang Y, Wang S, Ji F, Chen M, Yuan X, Tao Z, Zhang L. Seroprevalence of hepatitis B among the general population in Shandong Province, Eastern China, an update 30 years after the implementation of the neonatal vaccination program. BMC Infect Dis 2024; 24:1433. [PMID: 39695996 DOI: 10.1186/s12879-024-10340-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2024] [Accepted: 12/11/2024] [Indexed: 12/20/2024] Open
Abstract
BACKGROUND In 1992, Hepatitis B vaccine was first recommended for routine neonatal immunization in China. This study aimed to estimate the prevalence of hepatitis B virus (HBV) infection in Shandong Province, eastern China (updating our previous study in 2014), and to help guide the efforts of hepatitis B elimination. METHODS We determined prevalence of HBV infection from the remaining serum samples collected through a population-based survey, which was originally intended for a seroepidemiological survey of anti-SARS-CoV-2 antibodies conducted in 2023. The samples (n = 5000) were obtained from individuals all-aged over 1 year residing in ten counties of Shandong Province. The chemiluminescence microparticle immunoassay was used to detect serological markers of HBV. RESULTS In total, 4999 samples were eligible for the test of hepatitis B. The overall prevalence of HBsAg, anti-HBs, and anti-HBc in the 2023 survey was 2.25% (95%CI:1.64-2.87), 46.21% (95%CI:44.05-48.38), and 25.17% (95%CI:23.46-26.88), respectively. The HBsAg prevalence has dropped to 0.28% among individuals younger than 30 years, particularly with less than 0.1% among children aged 1-14 (considerably below the 8% prevalence recorded in 1992). The peak prevalence of HBsAg was observed in individuals aged 40-49 years (5.63%), followed by those aged 30-39 (3.11%). CONCLUSION The Shandong Province has achieved substantial success in controlling HBV infection among the younger generation through the newborn routine vaccination program. To accelerate progress towards the goal of eliminating hepatitis B in the province, additional strategies should also be adopted in parallel, including increasing diagnostic coverage, expanding antiviral treatment, and enhancing hepatitis B vaccine coverage for HBV-susceptible adults.
Collapse
Affiliation(s)
- Bingyu Yan
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Xiaomeng Zhang
- School of Public Health, Shandong University Cheeloo College of Medicine, Jinan, China
| | - Jingjing Lv
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Yi Feng
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Xin Meng
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Xiaojuan Lin
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Yan Zhang
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Suting Wang
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Feng Ji
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Meng Chen
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Xinyu Yuan
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Zexin Tao
- Shandong Center for Disease Control and Prevention, Jinan, China
| | - Li Zhang
- Shandong Center for Disease Control and Prevention, Jinan, China.
- School of Public Health, Shandong University Cheeloo College of Medicine, Jinan, China.
| |
Collapse
|
17
|
de Villiers MJ, de Villiers E, Nayagam S, Hallett TB. Direct and indirect effects of hepatitis B vaccination in four low- and middle-income countries. Epidemics 2024; 49:100798. [PMID: 39541625 PMCID: PMC11649532 DOI: 10.1016/j.epidem.2024.100798] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2024] [Revised: 10/03/2024] [Accepted: 10/03/2024] [Indexed: 11/16/2024] Open
Abstract
Population-level vaccination effects of the hepatitis B vaccine were investigated in four low- and middle-income countries with different levels of vertical and horizontal transmission. Indirect vaccination effects constitute a large proportion of overall vaccination effects of the vaccination programmes in all four countries (over 70% by 2030 in all four countries). However, countries with higher levels of vertical transmission benefit less from indirect vaccination effects from the infant hepatitis B vaccine series during the first decades of the vaccination programme, making the birth dose vaccine more important in these countries. Vaccination, even at levels that do not fully control transmission, has a great effect on the development of disease as it also increases the average age of infection, thereby causing a decrease in the number of chronic infections relative to the number of acute infections.
Collapse
Affiliation(s)
- Margaret J de Villiers
- MRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, United Kingdom.
| | | | - Shevanthi Nayagam
- MRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, United Kingdom; Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom
| | - Timothy B Hallett
- MRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, United Kingdom
| |
Collapse
|
18
|
Zoa-Assoumou S, M'boyis-Kamdem H, Mougola-Bissiengou P, Nzengui-Nzengui GF, Kombila-Koumavor C, Mbani-Okouma M, Mourembou G, Ndjoyi-Mbiguino A. Seroprevalence of hepatitis B virus markers of infection and immunity among people living in Libreville, Gabon. IJID REGIONS 2024; 13:100448. [PMID: 39885836 PMCID: PMC11780383 DOI: 10.1016/j.ijregi.2024.100448] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Revised: 09/06/2024] [Accepted: 09/06/2024] [Indexed: 02/01/2025]
Abstract
Objectives In Gabon, data on hepatitis B virus (HBV) infection are limited to hepatitis B surface antigen (HBsAg) detection among specific populations and rural regions. This is the first study aimed at determining the seroprevalence of HBV markers among the Gabonese population. Methods A retrospective study was conducted from January 2002 through December 2022. All patients who requested HBV marker screening (HBsAg, anti-HBc, anti-HBs, anti-HBe, hepatitis B e antigen) were included in this study. Results A total of 496 people were included in this study. The prevalence of HBV exposure was high (59.5%) and significantly associated with age, sex, pregnancy status, and social status. Among individuals with evidence of HBV exposure, only 89 (33.7%) had effectively cleared the virus. Overall, HBsAg was detected in 108 of the 496 (21.8%) people included in the study. HBsAg infection was more common among individuals in the 16-25 (35.1%) and 26-35-year (30.6%) age groups. Moreover, most of HBsAg-infected patients were health care workers (HCWs) (P = 0.0096). Among the 496 individuals included in this study, 126 (25.4%) were still susceptible to HBV. Most of the susceptible female patients were pregnant (P <0.0001). HCWs had a significantly lower probability of being naïve to HBV infection (P = 0.0001). There was a similar prevalence of susceptibility in male and female patients (50 [24.5%] male and 76 [26.0%] female patients). Only 15.1% of the studied population was vaccinated. Conclusions Our findings revealed a high seroprevalence of HBV infection in the study area and very low HBV immunization coverage. Additional care and resources should be provided to promote HBV vaccination and block vertical HBV transmission.
Collapse
Affiliation(s)
- Samira Zoa-Assoumou
- University of Health Sciences, Department of Bacteriology-Virology, Libreville, Gabon
- University of Hassan II Casablanca, Faculty of Sciences and Technologies Mohammedia, Laboratory of Virology, Microbiology and Quality/Ecotoxicology and Biodiversity, Casablanca, Morocco
| | - Hervé M'boyis-Kamdem
- University of Health Sciences, Department of Bacteriology-Virology, Libreville, Gabon
| | | | | | | | - Marina Mbani-Okouma
- University of Health Sciences, Department of Bacteriology-Virology, Libreville, Gabon
| | - Gael Mourembou
- University of Health Sciences, Department of Bacteriology-Virology, Libreville, Gabon
| | | |
Collapse
|
19
|
Girmay G, Bewket G, Amare A, Angelo AA, Wondmagegn YM, Setegn A, Wubete M, Assefa M. Seroprevalence of viral hepatitis B and C infections among healthcare workers in Ethiopia: A systematic review and meta-analysis. PLoS One 2024; 19:e0312959. [PMID: 39509362 PMCID: PMC11542802 DOI: 10.1371/journal.pone.0312959] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2024] [Accepted: 10/15/2024] [Indexed: 11/15/2024] Open
Abstract
BACKGROUND Healthcare workers (HCWs) are at higher risk of contracting hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. Currently, there is no estimate of pooled data on the prevalence of HBV and HCV infections among HCWs in the country. Thus, this review aimed to determine the pooled prevalence of hepatitis B and C infections among HCWs in Ethiopia. MATERIALS AND METHODS A comprehensive literature search was conducted using electronic databases, including PubMed, Cochrane Library, Science Direct, Hinari, and African Journals Online to identify pertinent articles from the inception to April 2024. The protocol has been registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD42024527940) and conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data were extracted independently by two authors and analyzed using STATA version 11 software. A random-effect model and Egger's test were computed to estimate the pooled prevalence and assess publication bias, respectively. RESULTS A total of 18 studies involving4,948 healthcare workers were included in this review to estimate the pooled prevalence of HBV and HCV infections among HCWs in Ethiopia. The overall prevalence of HBV was 5.93% (95% CI; 3.22-8.63). The sub-group analysis showed that the prevalence of HBV among medical waste handlers and health professionals was8.6% (95% CI; 3.01-14.13) and 4.98% (95% CI; 1.85-8.11), respectively. The combined prevalence of HCV was 1.12% (95% CI; -4.19-6.43). In the sub-group analysis, the prevalence of HCV among medical waste handlers and health professionals was1.44% (95% CI; -5.28-8.18) and 0.59% (95% CI; -8.09-9.27), respectively. CONCLUSION In this review, we found a higher (5.93%) and moderate (1.12%) prevalence of HBV and HCV infections, respectively among Ethiopian HCWs. Therefore, to reduce the infectious burden of HBV and HCV among HCWs; there is a need to strict adherence to infection prevention and control measures. In addition, adequate HBV vaccination coverage for HCWs is mandatory to reduce the burden of HBV infection in the country.
Collapse
Affiliation(s)
- Getu Girmay
- Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Gezahegn Bewket
- Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Azanaw Amare
- Department of Medical Microbiology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Abiy Ayele Angelo
- Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Yenesew Mihret Wondmagegn
- Department of Medical Parasitology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Abebaw Setegn
- Department of Medical Parasitology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| | - Menberu Wubete
- Department of Medical Laboratory sciences, College of Medicine and Health Sciences, Dire Dawa University, Dire Dawa, Ethiopia
| | - Muluneh Assefa
- Department of Medical Microbiology, School of Biomedical and Laboratory Science, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
| |
Collapse
|
20
|
Solomon-Rakiep T, Olivier J, Amponsah-Dacosta E. Towards contextualized complex systems approaches to scaling-up hepatitis B birth-dose vaccination in the African region: a qualitative systematic review. Front Public Health 2024; 12:1389633. [PMID: 39512716 PMCID: PMC11540787 DOI: 10.3389/fpubh.2024.1389633] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2024] [Accepted: 10/08/2024] [Indexed: 11/15/2024] Open
Abstract
Background Despite the longstanding implementation of universal hepatitis B infant vaccination programs, the World Health Organization African region (WHO AFRO) maintains the highest prevalence (2.5%) of chronic hepatitis B virus (HBV) infection among children ≤5 years of age. Scaling-up hepatitis B birth-dose (HepB BD) vaccination could avert mother-to-child transmission of HBV infection and advance regional progress towards eliminating viral hepatitis. Objective To describe whether - and how - complexities within the health system or intervention influence the performance of HepB BD vaccination programs in the WHO AFRO. Methods Using a complexity perspective, we conducted a qualitative systematic review of literature published between 2009-2022. A Boolean search strategy retrieved relevant literature indexed in PubMed, EBSCOhost databases, Scopus, and Web of Science, with supplementary searches conducted to identify any missed articles. No language restrictions were applied. Data extraction, synthesis and analysis were guided by a systems-based logic model tailored to systematic reviews of complex interventions. Results Our search yielded 672 published records. Of these, 28 (26 English, 2 French) were eligible for inclusion. Among the 12 WHO AFRO member states represented, the origin of evidence weighted highest in Nigeria (n = 12) and Senegal (n = 5). The performance of HepB BD vaccination programs across member states are influenced by underlying complexities across eight cross-cutting themes: (i) availability and interpretation of HepB BD vaccination policies, (ii) capacity of vaccine supply and cold chain systems, (iii) availability of equitable and sustainable financing, (iv) capacity and capability of health care workers (HCWs), (v) immunization monitoring systems and impaired feedback loops, (vi) influence of context vs system design on the timeliness of vaccination, (vii) maternal knowledge and socio-economic factors, and (viii) wider contextual factors (geography, climate, cultural practices). Conclusion Countries looking to introduce, or scale-up HepB BD vaccination programs will benefit from careful consideration of components of the intervention design that are dependent on the end-user's context and capabilities in accessing the vaccine; the adherence and interpretation of essential components of the policy; the provision of adequate support of stakeholders specifically HCWs and government ministries; and the need for innovative approaches to underlying complexities. Lessons offered by these African experiences provide pragmatic approaches to successfully implementing HepB BD vaccination programs in the region.
Collapse
Affiliation(s)
- Tasneem Solomon-Rakiep
- Health Policy and Systems Division, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town, South Africa
- Vaccines for Africa Initiative, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town, South Africa
| | - Jill Olivier
- Health Policy and Systems Division, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town, South Africa
| | - Edina Amponsah-Dacosta
- Vaccines for Africa Initiative, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town, South Africa
| |
Collapse
|
21
|
Shindano TA, Horsmans Y. Low level of awareness and prevention of hepatitis B among Congolese healthcare workers: urgent need for policy implementation. Front Public Health 2024; 12:1463455. [PMID: 39440169 PMCID: PMC11493591 DOI: 10.3389/fpubh.2024.1463455] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2024] [Accepted: 09/23/2024] [Indexed: 10/25/2024] Open
Abstract
The Democratic Republic of Congo (DRC) is a country with many public health challenges, including those related to the prevention and management of viral hepatitis B. Healthcare workers, who are at the frontline of patient care, are particularly at risk of contracting and spreading this virus, especially given its high prevalence in the general population. This paper examines the level of awareness and preventive measures among Congolese healthcare workers. Overall, the data show that health workers are under-immunized and lack formal training in hepatitis B prevention and management. In addition to limited awareness, health facilities are insufficiently involved in the implementation of standardized infection control protocols, the provision of personal protective equipment and routine hepatitis B vaccination programmes. There also appears to be a lack of clear and effective national policies outlining the main axes of infection control targets by 2030. This calls for urgent policy implementation focusing on mandatory vaccination, training, resource availability, adherence to infection control practices and comprehensive post-exposure management.
Collapse
Affiliation(s)
- Tony Akilimali Shindano
- Université Catholique de Bukavu, Bukavu, Democratic Republic of Congo
- Hôpital Provincial Général de Référence de Bukavu, Bukavu, Democratic Republic of Congo
- Department of Internal Medicine, University of Kindu, Kindu, Democratic Republic of Congo
- Center for Tropical Diseases and Global Health, CTDGH, Bukavu, Democratic Republic of Congo
| | - Yves Horsmans
- Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert, Belgium
| |
Collapse
|
22
|
Hutton DW, Toy M, Yang D, Zhang H, Handanagic S, Armstrong PA, Wasley A, Menzies NA, Pham H, Salomon JA, So SK. Modelling the potential impact of global hepatitis B vaccination on the burden of chronic hepatitis B in the United States. J Viral Hepat 2024; 31:614-622. [PMID: 39037155 PMCID: PMC11534504 DOI: 10.1111/jvh.13982] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/19/2024] [Revised: 06/14/2024] [Accepted: 07/03/2024] [Indexed: 07/23/2024]
Abstract
About 80% of persons with chronic hepatitis B virus (HBV) infection in the United States are non-US-born. Despite improvements in infant hepatitis B vaccination globally since 2000, work remains to attain the World Health Organization's (WHO) global 2030 goal of 90% vaccination. We explore the impacts on the United States of global progress in hepatitis B vaccination since 2000 and of achieving WHO hepatitis B vaccination goals. We simulated immigrants with HBV infection arriving to the United States from 2000 to 2070 using models of the 10 countries from which the largest numbers of individuals with HBV infection were born. We estimated costs in the United States among these cohorts using a disease simulation model. We simulated three scenarios: a scenario with no progress in infant vaccination for hepatitis B since 2000 (baseline), current (2020) progress and achieving WHO 2030 goals for hepatitis B vaccination. We estimate current hepatitis B vaccination progress since the 2000 baseline in these 10 countries will lead to 468,686 fewer HBV infections, avoid 35,582 hepatitis B-related deaths and save $4.2 billion in the United States through 2070. Achieving the WHO 2030 90% hepatitis B infant vaccination targets could lead to an additional 16,762 fewer HBV infections, 989 fewer hepatitis B-related deaths and save $143 million through 2070. Global hepatitis B vaccination since 2000 reduced prevalence of HBV infection in the United States. Achieving the WHO 2030 infant vaccination goals globally could lead to over one hundred million dollars in additional savings.
Collapse
Affiliation(s)
- David W. Hutton
- Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA
| | - Mehlika Toy
- Asian Liver Center, Department of Surgery, Stanford University School of Medicine, Stanford, California, USA
| | - Danwei Yang
- Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA
| | - Hanwen Zhang
- Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA
| | - Senad Handanagic
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
| | - Paige A. Armstrong
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
| | - Annemarie Wasley
- Global Immunizations Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
| | - Nicolas A. Menzies
- Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA
| | - Hang Pham
- Asian Liver Center, Department of Surgery, Stanford University School of Medicine, Stanford, California, USA
| | - Joshua A. Salomon
- Department of Health Policy, Stanford University School of Medicine, Stanford, California, USA
- Center for Health Policy, Freeman Spogli Institute for International Studies, Stanford University, Stanford, California, USA
| | - Samuel K. So
- Asian Liver Center, Department of Surgery, Stanford University School of Medicine, Stanford, California, USA
| |
Collapse
|
23
|
Gong X, Zheng C, Fang Q, Xu W, Yin Z. Survey of Hepatitis B Vaccination Coverage and Surface Antibody-Positive Rates in People Aged 1-59 Years in 2006 and 2024. Open Forum Infect Dis 2024; 11:ofae589. [PMID: 39431151 PMCID: PMC11488135 DOI: 10.1093/ofid/ofae589] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/27/2024] [Accepted: 10/02/2024] [Indexed: 10/22/2024] Open
Abstract
Background Implementing hepatitis B vaccination is an important strategy to reduce hepatitis B virus infection and disease burden. Suboptimal adult hepatitis B vaccination coverage limits the further reduction of hepatitis B virus infection. Methods A multistage stratified random sampling method was adopted to survey the permanent population aged 1-59 in 2006 and 2024. We calculated the vaccination coverage rate, hepatitis B surface antibody (HBsAb)-positive rate, rate difference, and their 95% confidence intervals (CIs) of the 2 survey populations, and used the 95% CI and χ2 test to determine whether the difference in rate was statistically significant. Results Six hundred twenty-three people were surveyed in 2006 and 606 people were surveyed in 2024. From 2006 to 2024, the hepatitis B vaccination coverage among people aged 1-59 years increased from 54.1% to 78.9%, and the HBsAb-positive rate increased from 46.2% to 57.6%. There was no significant difference in vaccination coverage in the population <15 years of age, but the antibody-positive rate increased significantly. The vaccination coverage rate of the 15-59 age group increased significantly, but there was no statistical difference in the antibody positivity rate of the 15-49 age group, and the antibody positivity rate of the 50-59 age group increased significantly. Conclusions Hepatitis B vaccination coverage among adults was still insufficient. Hepatitis B vaccine-mediated immunity was low in adults aged 30-49 years. It is recommended to update the guidelines for hepatitis B vaccination of adults in China, cancel the assessment of risk factors and prevaccination serological screening, and emphasize universal vaccination of all unvaccinated adults to increase coverage.
Collapse
Affiliation(s)
- Xiaoying Gong
- Department of Immunity, Quzhou Center for Disease Control and Prevention, Quzhou, Zhejiang, China
| | - Canjie Zheng
- Department of Immunity, Quzhou Center for Disease Control and Prevention, Quzhou, Zhejiang, China
| | - Quanjun Fang
- Department of Immunity, Quzhou Center for Disease Control and Prevention, Quzhou, Zhejiang, China
| | - Wenjie Xu
- Department of Immunity, Quzhou Center for Disease Control and Prevention, Quzhou, Zhejiang, China
| | - Zhiying Yin
- Department of Immunity, Quzhou Center for Disease Control and Prevention, Quzhou, Zhejiang, China
| |
Collapse
|
24
|
Han X, Zhang X, Zhong L, Liu Y, Gong L, Zhang J, Wang H, Chen Q. Evaluation of the immunization efficacy and adverse reactions of hepatitis B vaccination in children with thalassemia minor. BMC Public Health 2024; 24:2641. [PMID: 39334137 PMCID: PMC11438186 DOI: 10.1186/s12889-024-18779-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2023] [Accepted: 05/06/2024] [Indexed: 09/30/2024] Open
Abstract
OBJECTIVE To assess the immunization efficacy and incidence of adverse reactions after hepatitis B vaccination in children with thalassemia based on data from real-world studies. METHODS A total of 625 children were recruited into this cross-sectional study. Subgroup analyses of different thalassemia types were performed using binary logistic regression, the factors affecting HBsAb levels were identified using multiple linear regression, and the dose-response relationship between the duration of immunization and seroconversion was explored using the restricted cubic spline (RCS) model to further assess the protective duration of the hepatitis B vaccine. RESULTS HBsAb positivity in enrolled children was 87.3% in the thalassemia group and 81.4% in the control group. Multifactorial analysis revealed that the duration of immunization, age at completion of vaccination, and whether the first dose was delayed were significant factors influencing HBsAb levels in children (P < 0.05). The threshold for HBsAb positivity may be reached when the immunization duration reaches approximately 30 months. A subgroup analysis revealed that the HBsAb positivity rate was lower in children with β-thalassemia minor compared to those with α-thalassemia minor (P = 0.001, 95% CI: 0.097 ∼ 0.536). Adverse reactions after hepatitis B vaccination were dominated by general reactions, with a statistically significant difference in injection-site redness and swelling between the thalassemia and control groups (P < 0.05). CONCLUSIONS The immunization response to the hepatitis B vaccine in children with thalassemia minor was comparable to healthy children, with no abnormal adverse effects seen.
Collapse
Affiliation(s)
- Xue Han
- School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, China
| | - Xi Zhang
- School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, China
| | - Liling Zhong
- School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, China
| | - Ying Liu
- School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, China
| | - Lifen Gong
- Heyuan Center for Disease Control and Prevention, Heyuan, China
| | - Jikai Zhang
- Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, China
| | - Hai Wang
- Heyuan Center for Disease Control and Prevention, Heyuan, China.
| | - Qingsong Chen
- School of Public Health, Guangdong Pharmaceutical University, Guangzhou, 510310, China.
| |
Collapse
|
25
|
Ley D, Lazarus S, Forati AM, Farraye FA, Smith R, Hayney MS, Caldera F. High Rates of Seroprotection to Hepatitis B After a Hepatitis B Challenge Dose in Previously Vaccinated Patients with Inflammatory Bowel Disease on Immunosuppressive Therapy. Dig Dis Sci 2024; 69:3051-3060. [PMID: 38907090 DOI: 10.1007/s10620-024-08527-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2024] [Accepted: 06/10/2024] [Indexed: 06/23/2024]
Abstract
BACKGROUND Healthy populations have high rates of sustained vaccine-induced seroprotection to hepatitis B virus, but previous studies in immunosuppressed patients with inflammatory bowel disease (IBD) have shown suboptimal seroprotection rates. A challenge dose of hepatitis B vaccine (HepB) is recommended in previously vaccinated individuals who are seronegative to elicit an anamnestic response and determine if they are seroprotected. The aim of our study was to determine sustained seroprotection rates to hepatitis B vaccine (HepB) in patients with IBD. METHODS This was a single-center prospective study of patients with IBD previously vaccinated with a three dose HepB series. Patients had a hepatitis B surface antibody (anti-HBs) drawn; if it was below 10 mIU/mL, they received a challenge dose of the HepB vaccine to assess for anamnestic response and sustained seroprotection. The primary outcome was to determine the rate of sustained seroprotection (anti-HBs ≥ 10). RESULTS A total of 168 patients met inclusion criteria, mean age 35.7 years ± 13.6 standard deviation (SD). Initially 120 (71.4%) had anti-HBs ≥ 10 mIU/mL, with median anti-HBs of 37 mIU/mL (interquartile range 0-234); 48 (28.6%) needed a challenge dose, of which 34 responded with anti-HBs ≥ 10 mIU/mL. In total, 154 (91.7%) demonstrated sustained seroprotection to HepB. Those not seroprotected were more likely to have been vaccinated on immunosuppressive therapy or after their diagnosis of IBD. CONCLUSIONS Most vaccinated patients with IBD maintain sustained seroprotection to HepB despite prolonged exposure to immunosuppression. This contradicts prior studies and shows that immunosuppression does not lead to loss of seroprotection.
Collapse
Affiliation(s)
- Dana Ley
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, Madison, WI, 53705-2281, USA
| | - Sarah Lazarus
- Department of Medicine, Hennepin Healthcare, Minneapolis, MN, USA
| | - Amir Masound Forati
- Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Francis A Farraye
- Department of Gastroenterology and Hepatology, Inflammatory Bowel Disease Center, Mayo Clinic, Jacksonville, FL, USA
| | - Ryan Smith
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, Madison, WI, 53705-2281, USA
| | - Mary S Hayney
- School of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA
| | - Freddy Caldera
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, Madison, WI, 53705-2281, USA.
| |
Collapse
|
26
|
Darar Dirir S, Ahouidi AD, Drame A, Osman Abdi W, Youssouf Kayad G, Houmed Aboubakar M, Camara M, Toure Kane C, Diop Ndiaye H. Immunoprophylaxis failure and vaccine response in infants born to mothers with chronic hepatitis B infection in Djibouti. World J Hepatol 2024; 16:1039-1050. [PMID: 39086535 PMCID: PMC11287614 DOI: 10.4254/wjh.v16.i7.1039] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/30/2023] [Revised: 05/03/2024] [Accepted: 06/04/2024] [Indexed: 07/26/2024] Open
Abstract
BACKGROUND In endemic areas, vertical transmission of hepatitis B virus (HBV) remains a major source of the global reservoir of infected people. Eliminating mother-to-child transmission (MTCT) of HBV is at the heart of World Health Organization's goal of reducing the incidence of HBV in children to less than 0.1% by 2030. Universal screening for hepatitis B during pregnancy and neonatal vaccination are the main preventive measures. AIM To evaluate the efficacy of HBV vaccination combined with one dose of immunoglobulin in children born to hepatitis B surface antigen (HBsAg)-positive mothers in Djibouti city. METHODS We conducted a study in a prospective cohort of HBsAg-positive pregnant women and their infants. The study ran from January 2021 to May 2022, and infants were followed up to 7 mo of age. HBV serological markers and viral load in pregnant women were measured using aVidas microparticle enzyme-linked immunosorbent assay (Biomérieux, Paris, France) and the automated Amplix platform (Biosynex, Strasbourg, France). All infants received hepatitis B immunoglobulin and were vaccinated against HBV at birth. These infants were closely monitored to assess their seroprotective response and for failure of immunoprophylaxis. Simple logistic regression was also used to identify risk factors associated with immunoprophylaxis failure and poor vaccine response. All statistical analyses were performed with version 4.0.1 of the R software. RESULTS Of the 50 pregnant women recruited, the median age was 31 years, ranging from 18 years to 41 years. The MTCT rate in this cohort was 4% (2/50) in HBsAg-positive women and 67% (2/3) in hepatitis B e antigen-positive women with a viral load > 200000 IU/mL. Of the 48 infants who did not fail immunoprophylaxis, 8 (16%) became poor responders (anti-HB < 100 mIU/mL) after HBV vaccination and hepatitis B immunoglobulin, while 40 (84%) infants achieved a good level of seroprotection (anti-HB > 100 mIU/mL). Factors associated with this failure of immunoprophylaxis were maternal HBV DNA levels (> 200000 IU/mL) and hepatitis B e antigen-positive status (odds ratio = 158, 95% confidence interval: 5.05-4958, P < 0.01). Birth weight < 2500 g was associated with a poor immune response to vaccination (odds ratio = 34, 95% confidence interval: 3.01-383.86, P < 0.01). CONCLUSION Despite a failure rate of immunoprophylaxis higher than the World Health Organization target, this study showed that the combination of immunoglobulin and HBV vaccine was effective in preventing MTCT of HBV. Therefore, further studies are needed to better understand the challenges associated with immunoprophylaxis failure in infants in Djibouti city.
Collapse
Affiliation(s)
- Sahal Darar Dirir
- Laboratoire Medical de la Caisse National de Sécurité Social de Djibouti, Caisse National de Sécurité Social de Djibouti, Djibouti BP 696, Senegal
| | - Ambroise D Ahouidi
- Parasitology, Institut de Recherche en santé de Surveillance épidémiologique et de Formation, Dakar 7325, Senegal
| | - Aboubacry Drame
- Ecole Doctoral, Université Alioune Diop de Bambey, Dakar 7325, Senegal
| | - Warsama Osman Abdi
- Department of Des Soins, Caisse National de Securite Social, Djibouti 696, Senegal
| | | | | | - Makhtar Camara
- Centre Hospitalier Universitaire Aristide le Dantec, Laboratoire Bactériologie-Virologie-Hôpital Aristide le Dantec, Dakar 7325, Senegal
| | - Coumba Toure Kane
- Department of Virology, Institut de Recherche en Santé de Surveillance épidémiologique et de Formation, Dakar 7325, Senegal
| | - Halimatou Diop Ndiaye
- Bacteriology and Virology Laboratory, Le Dantec University Teaching Hospital, Dakar BP 7325, Senegal.
| |
Collapse
|
27
|
Costa JP, de Carvalho A, Paiva A, Borges O. Insights into Immune Exhaustion in Chronic Hepatitis B: A Review of Checkpoint Receptor Expression. Pharmaceuticals (Basel) 2024; 17:964. [PMID: 39065812 PMCID: PMC11279883 DOI: 10.3390/ph17070964] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/24/2024] [Revised: 07/17/2024] [Accepted: 07/18/2024] [Indexed: 07/28/2024] Open
Abstract
Hepatitis B, caused by the hepatitis B virus (HBV), often progresses to chronic infection, leading to severe complications, such as cirrhosis, liver failure, and hepatocellular carcinoma. Chronic HBV infection is characterized by a complex interplay between the virus and the host immune system, resulting in immune cell exhaustion, a phenomenon commonly observed in chronic viral infections and cancer. This state of exhaustion involves elevated levels of inhibitory molecules, cells, and cell surface receptors, as opposed to stimulatory counterparts. This review aims to elucidate the expression patterns of various co-inhibitory and co-stimulatory receptors on immune cells isolated from chronic hepatitis B (CHB) patients. By analyzing existing data, the review conducts comparisons between CHB patients and healthy adults, explores the differences between HBV-specific and total T cells in CHB patients, and examines variations between intrahepatic and peripheral immune cells in CHB patients. Understanding the mechanisms underlying immune exhaustion in CHB is crucial for developing novel immunotherapeutic approaches. This detailed analysis sheds light on the immune exhaustion observed in CHB and lays the groundwork for future combined immunotherapy strategies aimed at leveraging checkpoint receptors to restore immune function and improve clinical outcomes.
Collapse
Affiliation(s)
- João Panão Costa
- Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal;
- CNC-UC—Center for Neuroscience and Cell Biology, University of Coimbra, 3004-504 Coimbra, Portugal
- CIBB—Center for Innovative Biomedicine and Biotechnology, University of Coimbra, 3004-504 Coimbra, Portugal
| | - Armando de Carvalho
- Centro Hospitalar e Universitário de Coimbra, 3004-561 Coimbra, Portugal; (A.d.C.); (A.P.)
- Faculty of Medicine, University of Coimbra, 3004-504 Coimbra, Portugal
| | - Artur Paiva
- Centro Hospitalar e Universitário de Coimbra, 3004-561 Coimbra, Portugal; (A.d.C.); (A.P.)
| | - Olga Borges
- Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal;
- CNC-UC—Center for Neuroscience and Cell Biology, University of Coimbra, 3004-504 Coimbra, Portugal
- CIBB—Center for Innovative Biomedicine and Biotechnology, University of Coimbra, 3004-504 Coimbra, Portugal
| |
Collapse
|
28
|
Liu Y, Wu D, Zhang K, Ren R, Liu Y, Zhang S, Zhang X, Cheng J, Chen L, Huang J. Detection technology and clinical applications of serum viral products of hepatitis B virus infection. Front Cell Infect Microbiol 2024; 14:1402001. [PMID: 39035352 PMCID: PMC11257880 DOI: 10.3389/fcimb.2024.1402001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2024] [Accepted: 06/12/2024] [Indexed: 07/23/2024] Open
Abstract
Viral hepatitis, caused by its etiology, hepatitis virus, is a public health problem globally. Among all infections caused by hepatitis-associated viruses, hepatitis B virus (HBV) infection remains the most serious medical concern. HBV infection particularly affects people in East Asia and Africa, the Mediterranean region, and Eastern Europe, with a prevalence rate of > 2%. Currently, approximately 1 billion people worldwide are infected with HBV, and nearly 30% of them experience chronic infection. Chronic HBV infection can lead to chronic hepatitis B (CHB), liver cirrhosis, and hepatocellular carcinoma (HCC), resulting in the related death of approximately 1 million people annually. Although preventative vaccines and antiviral therapies are currently available, there is no cure for this infection. Clinical testing is not only the gateway for diagnosis of HBV infection, but also crucial for judging the timing of medication, evaluating the effect of antiviral therapy, and predicting the risk of relapse after drug withdrawal in the whole follow-up management of hepatitis B infected persons. With advances in detection technology, it is now possible to measure various viral components in the blood to assess the clinical status of HBV infection. Serum viral products of HBV infection, such as HBV DNA, HBV RNA, hepatitis B surface antigen, hepatitis B e-antigen, and hepatitis B core-related antigen, are non-invasive indicators that are critical for the rapid diagnosis and management of related diseases. Improving the sensitivity of monitoring of these products is essential, and the development of corresponding detection technologies is pivotal in achieving this goal. This review aims to offer valuable insights into CHB infection and references for its effective treatment. We provide a comprehensive and systematic overview of classical and novel methods for detecting HBV serum viral products and discusses their clinical applications, along with the latest research progress in this field.
Collapse
Affiliation(s)
- Ying Liu
- School of Life Sciences, Zhengzhou University, Zhengzhou, Henan, China
| | - Di Wu
- School of Life Sciences, Zhengzhou University, Zhengzhou, Henan, China
| | - Kui Zhang
- State Key Laboratory of Resource Insects, College of Sericulture, Textile and Biomass Sciences, Southwest University, Chongqing, China
| | - Rongrong Ren
- Department of Clinical Laboratory, Zhejiang Hospital, Hangzhou, Zhejiang, China
| | - Yuxuan Liu
- School of Life Sciences, Zhengzhou University, Zhengzhou, Henan, China
| | - Shuya Zhang
- School of Life Sciences, Zhengzhou University, Zhengzhou, Henan, China
| | - Xuanyu Zhang
- School of Life Sciences, Zhengzhou University, Zhengzhou, Henan, China
| | - Jilin Cheng
- Department of Gastroenterology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, China
| | - Liping Chen
- Department of Gastroenterology, Shanghai Geriatric Medical Center, Shanghai, China
| | - Jun Huang
- School of Life Sciences, Zhengzhou University, Zhengzhou, Henan, China
| |
Collapse
|
29
|
Harrison J, Lind P, Sawleshwarkar S, Pasupathy D, Yapa HM. Rapid systematic review of interventions to improve antenatal screening rates for syphilis, hepatitis B, and HIV in low- and middle-income countries. Int J Gynaecol Obstet 2024; 166:3-26. [PMID: 38391190 DOI: 10.1002/ijgo.15425] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2023] [Accepted: 01/31/2024] [Indexed: 02/24/2024]
Abstract
BACKGROUND Infectious diseases including syphilis, HIV, and hepatitis B are major contributors to maternal and neonatal morbidity and mortality worldwide, especially in low- and middle-income countries (LMICs). The World Health Organization has prioritized elimination of vertical transmission of these three diseases. OBJECTIVES To rapidly assess the impact of interventions designed to improve antenatal screening rates for syphilis, HIV, and hepatitis B in LMICs and to identify areas for future implementation research. SEARCH STRATEGY A comprehensive search was conducted across PubMed, Embase, and EconLit, targeting articles published between January 1, 2013, and June 27, 2023. SELECTION CRITERIA We included quantitative interventional studies in English, involving pregnant adults (15 years or older) from LMICs. Exclusions were studies based in high-income countries, qualitative studies, or those investigating accuracy of diagnostic methods. DATA COLLECTION AND ANALYSIS From an initial 5549 potential studies, 27 were finalized for review after various screening stages. Data extraction covered aspects such as study design, intervention details, and outcomes. Findings were qualitatively synthesized within a systems thinking framework. MAIN RESULTS The interventions assessed varied in terms of geographic locations, health care system levels, and modalities. The review highlighted the effectiveness of interventions such as community health interventions, service quality improvements, and financial incentives. CONCLUSIONS The study underscores the potential of specific interventions in enhancing antenatal screening rates in LMICs. However, there is a discernible research gap concerning hepatitis B. The findings emphasize the importance of capacity building and health systems strengthening in public health interventions.
Collapse
Affiliation(s)
- J Harrison
- Reproduction and Perinatal Centre, Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia
| | - P Lind
- Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia
| | - S Sawleshwarkar
- Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia
- Sydney Infectious Diseases Institute, Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia
| | - D Pasupathy
- Reproduction and Perinatal Centre, Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia
| | - H M Yapa
- Sydney Infectious Diseases Institute, Faculty of Medicine and Health, University of Sydney, Camperdown, New South Wales, Australia
| |
Collapse
|
30
|
Expert Consensus on the Prevention and Treatment of Chronic Hepatitis B in Children. INFECTIOUS DISEASES & IMMUNITY 2024; 4:106-120. [DOI: 10.1097/id9.0000000000000122] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/27/2024]
Abstract
Abstract
The aim of this consensus is to standardize the prevention, diagnosis, and treatment of chronic hepatitis B in children and to achieve the goal of “eliminating viral hepatitis as a major public health threat by 2030” issued by the World Health Organization. Formulated by organized experts of the Chinese Society of Infectious Diseases and Chinese Society of Hepatology, Chinese Medical Association; Group of Infectious Diseases, Chinese Pediatric Society, Chinese Medical Association; and the National Clinical Research Center for Infectious Diseases (Beijing), the consensus provides the latest evidence and recommendations for the prevention, diagnosis, and treatment of chronic hepatitis B in children.
Collapse
|
31
|
Loeb TA, Gunaratne MP, Iqbal S, Anderson M, McFall AM, Amrose P, Rodgers MA, Srikrishnan AK, Balagopal A, Lucas GM, Mehta SH, Thomas DL, Cloherty G, Thio CL, Solomon SS. Hepatitis B Virus in People who Inject Drugs and Men who Have Sex With Men With HIV in India: A Cross-sectional Study. Open Forum Infect Dis 2024; 11:ofae350. [PMID: 39022392 PMCID: PMC11252851 DOI: 10.1093/ofid/ofae350] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2024] [Accepted: 06/26/2024] [Indexed: 07/20/2024] Open
Abstract
Background People with HIV (PWH) who are coinfected with hepatitis B virus (HBV) have a higher risk of mortality compared with PWH alone. Populations such as people who inject drugs (PWID) and men who have sex with men (MSM) are particularly at high risk for HBV acquisition; yet, limited epidemiological data from these populations exist on HBV prevalence from low- and middle-income country settings (LMICs). Methods We characterized the prevalence and correlates of HBV serological markers in a sample of PWID and MSM with HIV recruited across 15 Indian cities using hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), and hepatitis B surface antibody (anti-HBs). Testing of stored specimens for the presence of these markers was performed on the Abbott ARCHITECT i1000 as per the manufacturer's instructions. Correlates of ever being infected with HBV (reactive for anti-HBc and/or HBsAg) and chronic HBV (reactive for HBsAg) among those ever infected were assessed using univariable and multivariable multilevel logistic regression models accounting for site-level clustering. Results A total of 2198 (95%) of the 2314 participants recruited for the trial were screened for HBV markers. The median age among the PWID and MSM participants was 30 and 32 years, respectively. The prevalence of ever being infected with HBV was 75.6% vs 46.9% in PWID vs MSM, respectively (P < .01); prevalence of chronic infection was also higher in PWID vs MSM (14.1% vs 9.5%; P < .01). Correlates of ever being infected with HBV among PWID included unstable housing (adjusted odds ratio [aOR], 5.02) and sharing injection paraphernalia (aOR, 2.70), and among MSM, correlates included history of injection drug use (aOR, 4.87) and gender identity. The prevalence of isolated core (anti-HBc in the absence of anti-HBs) was 34.7% vs 29.4% in PWID vs MSM (P < .05). Vaccination serostatus was <10% in both populations. Conclusions In this large sample of PWID and MSM with HIV, we observed a high prevalence of serology consistent with HBV infection and low vaccination, highlighting the need for routine screening and catch-up vaccination. The high prevalence of isolated anti-HBc reactivity highlights the need to understand the risk of reactivation with this serological pattern.
Collapse
Affiliation(s)
- Talia A Loeb
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - Mihili P Gunaratne
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - Syed Iqbal
- YR Gaitonde Centre for AIDS Research and Education, Chennai, India
| | | | - Allison M McFall
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - Pradeep Amrose
- YR Gaitonde Centre for AIDS Research and Education, Chennai, India
| | | | | | - Ashwin Balagopal
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Gregory M Lucas
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Shruti H Mehta
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - David L Thomas
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | | | - Chloe L Thio
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Sunil S Solomon
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| |
Collapse
|
32
|
Hausdorff WP, Madhi SA, Kang G, Kaboré L, Tufet Bayona M, Giersing BK. Facilitating the development of urgently required combination vaccines. Lancet Glob Health 2024; 12:e1059-e1067. [PMID: 38636529 PMCID: PMC11099297 DOI: 10.1016/s2214-109x(24)00092-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2023] [Revised: 01/25/2024] [Accepted: 02/22/2024] [Indexed: 04/20/2024]
Abstract
The essence of a vaccine lies in its ability to elicit a set of immune responses specifically directed at a particular pathogen. Accordingly, vaccines were historically designed, developed, registered, recommended, procured, and administered as monopathogen formulations. Nonetheless, the control and elimination of an astonishing number of diseases was realised only after several once-separate vaccines were provided as combinations. Unfortunately, the current superabundance of recommended and pipeline vaccines is now at odds with the number of acceptable vaccine administrations and feasible health-care visits for vaccine recipients and health-care providers. Yet, few new combinations are in development because, in addition to the scientific and manufacturing hurdles intrinsic to coformulation, developers face a gauntlet of regulatory, policy, and commercialisation obstacles in a milieu still largely designed for monopathogen vaccines. We argue here that national policy makers and public health agencies should prospectively identify and advocate for the development of new multipathogen combination vaccines, and suggest ways to accelerate the regulatory pathways to licensure of combinations and other concrete, innovative steps to mitigate current obstacles.
Collapse
Affiliation(s)
- William P Hausdorff
- Center for Vaccine Innovation and Access, PATH, Washington, DC, USA; Faculty of Medicine, Université Libre de Bruxelles, Brussels, Belgium.
| | - Shabir A Madhi
- South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Johannesburg, South Africa
| | | | - Lassané Kaboré
- PATH, Center for Vaccine Innovation and Access, Dakar, Senegal; Gavi, The Vaccine Alliance, Geneva, Switzerland
| | | | - Birgitte K Giersing
- WHO Department of Immunization, Vaccines and Biologicals, Geneva, Switzerland
| |
Collapse
|
33
|
Liu X, Pang X, Wan Z, Zhao J, Gao Z, Deng H. Dopamine Inhibits the Expression of Hepatitis B Virus Surface and e Antigens by Activating the JAK/STAT Pathway and Upregulating Interferon-stimulated Gene 15 Expression. J Clin Transl Hepatol 2024; 12:443-456. [PMID: 38779516 PMCID: PMC11106351 DOI: 10.14218/jcth.2024.00051] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2024] [Revised: 04/16/2024] [Accepted: 04/17/2024] [Indexed: 05/25/2024] Open
Abstract
Background and Aims Hepatitis B virus (HBV) infection is a major risk factor for cirrhosis and liver cancer, and its treatment continues to be difficult. We previously demonstrated that a dopamine analog inhibited the packaging of pregenomic RNA into capsids. The present study aimed to determine the effect of dopamine on the expressions of hepatitis B virus surface and e antigens (HBsAg and HBeAg, respectively) and to elucidate the underlying mechanism. Methods We used dopamine-treated HBV-infected HepG2.2.15 and NTCP-G2 cells to monitor HBsAg and HBeAg expression levels. We analyzed interferon-stimulated gene 15 (ISG15) expression in dopamine-treated cells. We knocked down ISG15 and then monitored HBsAg and HBeAg expression levels. We analyzed the expression of Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway factors in dopamine-treated cells. We used dopamine hydrochloride-treated adeno-associated virus/HBV-infected mouse model to evaluate HBV DNA, HBsAg, and HBeAg expression. HBV virus was collected from HepAD38.7 cell culture medium. Results Dopamine inhibited HBsAg and HBeAg expression and upregulated ISG15 expression in HepG2.2.15 and HepG2-NTCP cell lines. ISG15 knockdown increased HBsAg and HBeAg expression in HepG2.2.15 cells. Dopamine-treated cells activated the JAK/STAT pathway, which upregulated ISG15 expression. In the adeno-associated virus-HBV murine infection model, dopamine downregulated HBsAg and HBeAg expression and activated the JAK-STAT/ISG15 axis. Conclusions Dopamine inhibits the expression of HBsAg and HBeAg by activating the JAK/STAT pathway and upregulating ISG15 expression.
Collapse
Affiliation(s)
- Xiaoquan Liu
- Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Guangdong, China
| | - Xiuqing Pang
- Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Guangdong, China
| | - Zhiping Wan
- Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Guangdong, China
| | - Jinhua Zhao
- Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Guangdong, China
| | - Zhiliang Gao
- Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Guangdong, China
- Key Laboratory of Tropical Disease Control (Sun Yat-sen University), Ministry of Education, Guangzhou, Guangdong, China
| | - Hong Deng
- Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
- Guangdong Key Laboratory of Liver Disease Research, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Guangdong, China
- Key Laboratory of Tropical Disease Control (Sun Yat-sen University), Ministry of Education, Guangzhou, Guangdong, China
| |
Collapse
|
34
|
Kong H, Cui X, Zhang Y, Xue Q, Shi J, Yao T, Guo Y, Xu X, Wang S, Feng Y. Occurrence and Reduction of Hepatitis B Vaccine Hesitancy Among Medical University Students - Shanxi Province, China, 2020. China CDC Wkly 2024; 6:431-436. [PMID: 38854750 PMCID: PMC11153866 DOI: 10.46234/ccdcw2024.081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2023] [Accepted: 01/12/2024] [Indexed: 06/11/2024] Open
Abstract
What is already known about this topic? Previous research has primarily examined the issue of hepatitis B vaccine hesitancy in migrant workers and other adult populations. However, there is a lack of studies that have specifically investigated the prevalence of hepatitis B vaccine hesitancy among university students. What is added by this report? In this study, 19.84% of students expressed hesitancy towards receiving the hepatitis B immunization. A negative correlation was observed between hepatitis B vaccine hesitancy and knowledge, attitudes, and practices related to hepatitis B. Conversely, a positive relationship was identified between hepatitis B-related knowledge and attitudes and practices. What are the implications for public health practice? This study examines the factors contributing to vaccine hesitancy towards hepatitis B at a medical university in China. The results have significant implications for developing strategies to improve hepatitis B vaccination rates.
Collapse
Affiliation(s)
- Huijuan Kong
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| | - Xufeng Cui
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| | - Ying Zhang
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| | - Qiang Xue
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
| | - Jing Shi
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| | - Tian Yao
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- First Hospital/First Clinical Medical College of Shanxi Medical University, Taiyuan City, Shanxi Province, China
| | - Yana Guo
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| | - Xiuyang Xu
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| | - Suping Wang
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| | - Yongliang Feng
- School of Public Health, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan City, Shanxi Province, China
- Key Laboratory of Coal Environmental Pathogenicity and Prevention (Shanxi Medical University), Ministry of Education, Taiyuan City, Shanxi Province, China
| |
Collapse
|
35
|
Sanchez-Gendriz I, Carvalho DDA, Galvão-Lima LJ, Sales-Moioli AIL, Brito T, Fernandes F, Henriques J, Lima T, Guedes LA, Cruz AS, Morais AHF, Santos JPQ, Arrais E, Coutinho KD, Machado GM, Cunha-Oliveira A, Dos Reis Vale Gomes CA, Valentim RAM. Digital dual test syphilis/HIV detection based on Fourier Descriptors of Cyclic Voltammetry curves. Comput Biol Med 2024; 174:108454. [PMID: 38608326 DOI: 10.1016/j.compbiomed.2024.108454] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/24/2023] [Revised: 03/10/2024] [Accepted: 04/07/2024] [Indexed: 04/14/2024]
Abstract
BACKGROUND Effective and timely detection is vital for mitigating the severe impacts of Sexually Transmitted Infections (STI), including syphilis and HIV. Cyclic Voltammetry (CV) sensors have shown promise as diagnostic tools for these STI, offering a pathway towards cost-effective solutions in primary health care settings. OBJECTIVE This study aims to pioneer the use of Fourier Descriptors (FDs) in analyzing CV curves as 2D closed contours, targeting the simultaneous detection of syphilis and HIV. METHODS Raw CV signals are filtered, resampled, and transformed into 2D closed contours for FD extraction. Essential shape characteristics are captured through selected coefficients. A complementary geometrical analysis further extracts features like curve areas and principal axes lengths from CV curves. A Mahalanobis Distance Classifier is employed for differentiation between patient and control groups. RESULTS The evaluation of the proposed method revealed promising results with classification performance metrics such as Accuracy and F1-Score consistently achieving values rounded to 0.95 for syphilis and 0.90 for HIV. These results underscore the potential efficacy of the proposed approach in differentiating between patient and control samples for STI detection. CONCLUSION By integrating principles from biosensors, signal processing, image processing, machine learning, and medical diagnostics, this study presents a comprehensive approach to enhance the detection of both syphilis and HIV. This setts the stage for advanced and accessible STI diagnostic solutions.
Collapse
Affiliation(s)
- Ignacio Sanchez-Gendriz
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil.
| | - Dionísio D A Carvalho
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Leonardo J Galvão-Lima
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Ana Isabela Lopes Sales-Moioli
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Talita Brito
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Felipe Fernandes
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Jorge Henriques
- Department of Informatics Engineering, Center for Informatics and Systems of the University of Coimbra, Universidade de Coimbra, Coimbra, Portugal
| | - Thaisa Lima
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil; Ministry of Health, Esplanada dos Ministérios, Brasília, Brazil
| | - Luiz Affonso Guedes
- Department of Computer Engineering and Automation, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Agnaldo S Cruz
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Antonio H F Morais
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil; Advanced Nucleus of Technological Innovation (NAVI), Federal Institute of Rio Grande do Norte, Natal/RN, Brazil
| | - João Paulo Q Santos
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil; Advanced Nucleus of Technological Innovation (NAVI), Federal Institute of Rio Grande do Norte, Natal/RN, Brazil
| | - Ernano Arrais
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil; Department of Biomedical Engineering, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | - Karilany Dantas Coutinho
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil; Department of Biomedical Engineering, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| | | | - Aliete Cunha-Oliveira
- Health Sciences Research Unit, Nursing (UICISA: E) and Nursing School of Coimbra (ESEnfC), Coimbra, Portugal; Center for Interdisciplinary Studies - CEIS20, University of Coimbra, Coimbra, Portugal
| | | | - Ricardo A M Valentim
- Laboratory of Technological Innovation in Health (LAIS), Hospital Universitário Onofre Lopes, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil; Department of Biomedical Engineering, Federal University of Rio Grande do Norte (UFRN), Natal/RN, Brazil
| |
Collapse
|
36
|
Andersen LL. Health Promotion and Chronic Disease Prevention at the Workplace. Annu Rev Public Health 2024; 45:337-357. [PMID: 37788631 DOI: 10.1146/annurev-publhealth-060222-035619] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/05/2023]
Abstract
The concept of workplace safety and health has focused largely on preventing accidents and on minimizing hazardous exposures. However, because workers spend a substantial part of their waking hours at the workplace, the potential to influence the health of a large proportion of the world's population through the workplace is enormous. The opportunities to carry out health promotion and chronic disease prevention activities at the workplace are countless, including (a) health screening; (b) tobacco cessation activities; (c) the promotion of healthy food choices and weight loss; (d) active breaks with physical exercise in terms of microexercise, enhancement of infrastructure to stimulate physical activity, and organization of work tasks to facilitate incidental physical activity; and (e) routine vaccinations. This review discusses the key factors necessary to implement health promotion and chronic disease prevention programs at the workplace (SWOLE model) and discusses the different foci and possibilities with respect to the differing nature of work for the blue- versus white-collar workforce.
Collapse
Affiliation(s)
- Lars Louis Andersen
- National Research Centre for the Working Environment, Copenhagen, Denmark;
- Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
| |
Collapse
|
37
|
By Y, Le LV, Suy S, Chou M, Chan PL, Heng K, Phou S, Ny C, Deng S, Phoeung CL, Mam S, Ferradini L, Babin FX, Saphonn V. Knowledge, attitudes, practices and prevalence of hepatitis B and C and hepatitis B vaccination coverage among public sector healthcare workers in Cambodia. Glob Health Med 2024; 6:108-116. [PMID: 38690134 PMCID: PMC11043119 DOI: 10.35772/ghm.2023.01097] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/31/2023] [Revised: 11/23/2023] [Accepted: 12/25/2023] [Indexed: 05/02/2024]
Abstract
Healthcare workers (HCWs) are a key population at high risk for hepatitis B (HBV) and hepatitis C (HCV) infections. We aim to study HBV vaccination coverage, seroprevalence, knowledge, attitudes, and practices towards HBV and HCV infections among HCWs in public sector in Cambodia. A nationally representative cross-sectional study was implemented in 2019, among Cambodian HCWs. A standardized questionnaire was administered to randomly selected HCWs whose blood was then sampled. We used univariate and multivariate regression to determine predictors of outcomes. Among 755 participants, we found 4.9% positive HBsAg and 2.3% positive anti-HCV Ab. HBV vaccination coverage was 59.3%. Lack of knowledge was found on the route of transmission, HBV vaccination, diagnosis and treatment of HBV and HCV. 67% of HCWs thought that all patients should be screened for HBV and HCV and about 30% of them would refuse to take care of infected patients. 58% of HCWs always recapped the needle after use. In univariate analysis, older age-group (> 50 years) is more likely to have positive anti-HCV (OR: 9.48; 95% CI: 2.36-38.18). HCWs who were younger, female or having higher education or having ever been tested, were more likely to have gotten HBV vaccinated. Multivariate analysis reconfirmed these predictors of getting vaccinated. Study findings indicated an urgent need of a national policy for Cambodian HCWs given the high prevalence of hepatitis among this group. Policy should include an effective in-service training program to improve knowledge and practices, a testing and vaccination program for HCWs and it should emphasize stigma intervention towards people living with HBV/HCV.
Collapse
Affiliation(s)
- Youlet By
- University of Health Sciences, Phnom Penh, Cambodia
- Fondation Mérieux, Phnom Penh, Cambodia
| | - Linh-Vi Le
- World Health Organization Regional Office for the Western Pacific, Manila, Philippines
| | | | | | - Po-lin Chan
- World Health Organization Regional Office for the Western Pacific, Manila, Philippines
| | - Kanika Heng
- University of Health Sciences, Phnom Penh, Cambodia
| | | | - Chanthou Ny
- University of Health Sciences, Phnom Penh, Cambodia
| | | | | | - Sovatha Mam
- University of Health Sciences, Phnom Penh, Cambodia
| | | | | | | |
Collapse
|
38
|
Mironova M, Ghany MG. Hepatitis B Vaccine: Four Decades on. Vaccines (Basel) 2024; 12:439. [PMID: 38675820 PMCID: PMC11053833 DOI: 10.3390/vaccines12040439] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2024] [Revised: 04/09/2024] [Accepted: 04/11/2024] [Indexed: 04/28/2024] Open
Abstract
Hepatitis B virus is a substantial contributor to cirrhosis and hepatocellular carcinoma (HCC) globally. Vaccination is the most effective method for prevention of hepatitis B and its associated morbidity and mortality, and the only method to prevent infection with hepatitis D virus. The hepatitis B vaccine has been used worldwide for more than four decades; it is available in a single- or triple-antigen form and in combination with vaccines against other infections. Introduction of the vaccine and administration at birth led to sustained decline in mother-to-child transmission, chronic hepatitis B, and HCC, however, global birth dose coverage remains suboptimal. In this review we will discuss different hepatitis B vaccine formulations and schedules, vaccination guidelines, durability of the response, and vaccine escape mutants, as well as the clinical and economic benefits of vaccination.
Collapse
Affiliation(s)
| | - Marc G. Ghany
- Clinical Hepatology Research Section, Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD 20892-1800, USA;
| |
Collapse
|
39
|
Olakunde BO, Ifeorah IM, Adeyinka DA, Olakunde OA, Ogundipe T, Olawepo JO, Ezeanolue EE. Immune response to hepatitis B vaccine among children under 5 years in Africa: a meta-analysis. Trop Med Health 2024; 52:28. [PMID: 38561838 PMCID: PMC10983738 DOI: 10.1186/s41182-024-00594-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2024] [Accepted: 03/17/2024] [Indexed: 04/04/2024] Open
Abstract
BACKGROUND Hepatitis B virus (HBV) infection in Africa is mostly acquired before the age of 5 years through vertical or horizontal routes. While all the countries in the World Health Organization African region have introduced HBV vaccination into their national immunization programs, the rate of protective immune response to HBV vaccine among children in Africa has not been systematically synthesized. In this study, we estimated the HBV vaccine seroprotection rate (defined as anti-HBs titer ≥ 10 IU/L) and the associated factors among under-five children who completed a primary series of HBV vaccination in Africa. METHODS We systematically searched PubMed, Web Science, and Scopus databases from inception to May 2022 for potentially eligible studies. The pooled seroprotection rate was estimated using a random-effects model with Freeman-Tukey double arcsine transformation and the associated factors were examined using odds ratio estimated by the DerSimonian and Laird method. RESULTS From the 1063 records identified, 29 studies with a total sample size of 9167 under-five children were included in the meta-analysis. The pooled seroprotection rate was 89.23% (95% CI 85.68-92.33%, I2 = 95.96%, p < 0.001). In the subgroup analyses, there was a significant difference in the rate by the assay method, vaccine dose, and vaccine combination. HIV-positive children had lower odds of achieving seroprotection when compared with HIV-negative children (OR = 0.22, 95%CI 0.12-0.40). CONCLUSIONS The majority of under-five children in Africa achieved seroprotection after completing three or four doses of HBV vaccine. However, the rate was lower among children living with HIV. This calls for interventions to timely identify and address nonresponse to HBV vaccine, particularly among immunosuppressed children.
Collapse
Affiliation(s)
- Babayemi O Olakunde
- Department of Community Prevention and Care Services, National Agency for the Control of AIDS, Abuja, Nigeria.
- Center for Translation and Implementation Research, University of Nigeria Nsukka, Enugu, Nigeria.
- Department of Population and Community Health, School of Public Health, University of North Texas Health Science Center, 3500 Camp Bowie Blvd., Fort Worth, TX, 76107, USA.
| | - Ijeoma M Ifeorah
- Center for Translation and Implementation Research, University of Nigeria Nsukka, Enugu, Nigeria
- Department of Medical Laboratory Sciences, University of Nigeria Nsukka, Enugu, Nigeria
| | - Daniel A Adeyinka
- Department of Research, Saskatchewan Health Authority, Saskatoon, SK, Canada
- Department of Public Health, Federal Ministry of Health, Abuja, Nigeria
| | - Olubunmi A Olakunde
- Department of Disease Control and Immunization, Ondo State Primary Health Care Development Agency, Ondo, Nigeria
| | | | - John O Olawepo
- Center for Translation and Implementation Research, University of Nigeria Nsukka, Enugu, Nigeria
- Department of Health Sciences, Northeastern University, Boston, MA, USA
| | - Echezona E Ezeanolue
- Center for Translation and Implementation Research, University of Nigeria Nsukka, Enugu, Nigeria
- Healthy Sunrise Foundation, Nevada, USA
| |
Collapse
|
40
|
Qiu J, Zhang S, Feng Y, Su X, Cai J, Chen S, Liu J, Huang S, Huang H, Zhu S, Wen H, Li J, Yan H, Diao Z, Liang X, Zeng F. Efficacy and safety of hepatitis B vaccine: an umbrella review of meta-analyses. Expert Rev Vaccines 2024; 23:69-81. [PMID: 38055218 DOI: 10.1080/14760584.2023.2289566] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2023] [Accepted: 11/27/2023] [Indexed: 12/07/2023]
Abstract
BACKGROUND There is a lack of synthesis of literature to determine hepatitis B vaccine (HepB) strategies for hepatitis B virus (HBV) supported by quality evidence. We aimed to explore the efficacy and safety of HepB strategies among people with different characteristics. RESEARCH DESIGN AND METHODS PubMed, Cochrane Library, Embase, and Web of Science were searched for meta-analyses comparing the efficacy and safety of HepB up to July 2023. RESULTS Twenty-one meta-analyses comparing 83 associations were included, with 16 high quality, 4 moderate, and 1 low quality assessed by AMSTAR 2. Highly suggestive evidence supports HepB booster and HepB with 1018 adjuvant (HBsAg-1018) for improved seroprotection, and targeted and universal HepB vaccination reduced HBV infection Suggestive evidence indicated that targeted vaccination decreased the rate of hepatitis B surface antibody positivity and booster doses increased seroprotection in people aged 10-20. Weak evidence suggests potential local/systemic reaction risk with nucleotide analogs or HBsAg-1018. Convincing evidence shows HLA-DPB1*04:01 and DPB1*04:02 increased, while DPB1*05:01 decreased, hepatitis B antibody response. Obesity may reduce HepB seroprotection, as highly suggested. CONCLUSION Targeted vaccination could effectively reduce HBV infection, and adjuvant and booster vaccinations enhance seroprotection without significant reaction. Factors such as obesity and genetic polymorphisms may affect the efficacy.
Collapse
Affiliation(s)
- Jiamin Qiu
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Shiwen Zhang
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Yonghui Feng
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Xin Su
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Jun Cai
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Shiyun Chen
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Jiazi Liu
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Shiqi Huang
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Haokun Huang
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Sui Zhu
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Huiyan Wen
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Jiaxin Li
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Haoyu Yan
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Zhiquan Diao
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
| | - Xiaofeng Liang
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
- Jinan University-BioKangtai Vaccine Institute, Jinan University, Shenzhen, China
| | - Fangfang Zeng
- Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou, PR China
- Jinan University-BioKangtai Vaccine Institute, Jinan University, Shenzhen, China
| |
Collapse
|
41
|
Wu J, He J, Xu H. Global prevalence of occult HBV infection in children and adolescents: A systematic review and meta-analysis. Ann Hepatol 2024; 29:101158. [PMID: 37748752 DOI: 10.1016/j.aohep.2023.101158] [Citation(s) in RCA: 6] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/28/2023] [Revised: 08/17/2023] [Accepted: 09/11/2023] [Indexed: 09/27/2023]
Abstract
INTRODUCTION AND OBJECTIVES Occult HBV infection (OBI) is a specific form of hepatitis B virus (HBV) infection and has the possibility of developing into hepatocellular carcinoma (HCC) in adults. This study aimed to estimate the global prevalence of occult HBV infection in children and adolescents. MATERIALS AND METHODS We systematically searched PubMed, Embase, Web of Science, and Cochrane databases for relevant studies on the prevalence of OBI in children and adolescents. Meta-analysis was performed using STATA 16 software. RESULTS Fifty studies were included. The overall prevalence of OBI in children and adolescents was 7.5% (95% CI: 0.050-0.103). In different risk populations, OBI prevalence was remarkably high in the HIV-infected population (24.2%, 95% CI: 0.000-0.788). The OBI prevalence was 0.8% (95% CI:0.000-0.029) in the healthy population, 3.8% (95% CI:0.012-0.074) in the general population, and 6.4% (95% CI: 0.021-0.124) in children born to HBsAg-positive mothers. Based on different serological profiles, the prevalence of OBI in HBsAg-negative and anti-HBc-positive patients was 6.6% (95% CI: 0.016-0.136), 3.0% (95% CI: 0.009-0.059) in HBsAg-negative and anti-HBc-negative patients, 4.6% (95% CI: 0.015-0.088) in HBsAg-negative and anti-HBs-positive patients, and 3.7% (95% CI: 0.001-0.102) in HBsAg-negative and anti-HBs-negative patients. CONCLUSIONS Despite HBV vaccination and hepatitis B immunoglobulin (HBIG), OBI is common in children and adolescents in high-risk groups.
Collapse
Affiliation(s)
- Jiaying Wu
- Department of Infectious Diseases, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Infection and Immunity, Chongqing, China; The First batch of key Disciplines On Public Health in Chongqing, Health Commission of Chongqing, Chongqing, China
| | - Jiayao He
- Affiliated Hospital of Chengdu University, Chengdu, China
| | - Hongmei Xu
- Department of Infectious Diseases, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Infection and Immunity, Chongqing, China; The First batch of key Disciplines On Public Health in Chongqing, Health Commission of Chongqing, Chongqing, China.
| |
Collapse
|
42
|
Amaral TDS, Alves CMDS, Rezende FR, Caetano KAA, Tipple AFV. Evaluación serológica y vacuna para la hepatitis B entre Agentes Comunitarios de Salud. Rev Lat Am Enfermagem 2023. [DOI: 10.1590/1518-8345.6107.3764] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
Abstract
Resumen Objetivo: identificar la situación de la vacunación y serología contra la hepatitis B entre agentes comunitarios de la salud, vacunar contra el virus de la hepatitis B y evaluar la respuesta inmunológica de los agentes susceptibles. Método: fase I, estudio transversal y descriptivo, entre agentes comunitarios de la salud de una capital de la región centro oeste, por medio de cuestionario autoadministrado, verificación del carné de vacunación y extracción de sangre para comprobar los marcadores serológicos para la hepatitis B. Fase II, estudio de cohorte realizado en trabajadores vacunados no inmunes e identificados en la Fase I; estos recibieron una dosis de la vacuna (dosis de desafío) y realizaron el test serológico. Resultados: participaron del estudio 109 agentes. La mayoría tenía registro de vacunación (97; 89,0%) y de cobertura de vacunación (75; 77,3%); el marcador anti-HBs (Anticuerpos contra el virus de la hepatitis B) aislado fue detectado en 78 (71,6%) de los agentes. La prevalencia de exposición al virus de la hepatitis B fue de 8,2%. De los diez agentes vacunados no inmunes, después de la dosis desafío, uno permaneció susceptible. Conclusión: a pesar de que la mayoría de los trabajadores estaban vacunados y presentaron respuesta inmunológica para la hepatitis B, la susceptibilidad, después de la dosis desafío, fue identificada. Por tanto, es necesario que exista un programa de vigilancia de la situación de vacunación y estado serológico para este virus, para promover la seguridad de estos trabajadores.
Collapse
Affiliation(s)
- Tauana de Souza Amaral
- Universidade Federal de Goiás, Brazil; Fundação de Amparo à Pesquisa no Estado de Goiás, Brazil
| | | | | | | | | |
Collapse
|
43
|
Amaral TDS, Alves CMDS, Rezende FR, Caetano KAA, Tipple AFV. Avaliação sorológica e vacinal para hepatite B entre Agentes Comunitários de Saúde. Rev Lat Am Enfermagem 2023. [DOI: 10.1590/1518-8345.6107.3766] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
Abstract
Resumo Objetivo: identificar a situação vacinal e sorológica contra hepatite B entre agentes comunitários de saúde; vacinar contra o vírus da hepatite B e avaliar a resposta imunológica dos agentes susceptíveis. Método: fase I, estudo transversal e descritivo, entre agentes comunitários de saúde de uma capital da região Centro-oeste, por meio de questionário autoaplicável, conferência do cartão vacinal e coleta de sangue para testagem dos marcadores sorológicos para hepatite B. Fase II, estudo de coorte realizado em trabalhadores vacinados não imunes e identificados na fase I. Estes receberam uma dose da vacina (dose desafio) e teste sorológico. Resultados: participaram do estudo 109 agentes. A maioria tinha registro de vacinação (97; 89,0%) e completude vacinal (75; 77,3%), já o marcador anti-HBs (anticorpos contra o vírus da hepatite B) isolado foi detectado em 78 (71,6%) agentes. A prevalência de exposição ao vírus da hepatite B foi de 8,2%. Dos dez agentes vacinados não imunes, após a dose desafio, um permaneceu susceptível. Conclusão: apesar da maioria dos trabalhadores estarem vacinados e apresentarem resposta imunológica para hepatite B, a suscetibilidade após a dose desafio foi identificada. Portanto, é necessário que haja um programa de vigilância da situação vacinal e estado sorológico para este vírus, para promover a segurança destes trabalhadores.
Collapse
Affiliation(s)
- Tauana de Souza Amaral
- Universidade Federal de Goiás, Brazil; Fundação de Amparo à Pesquisa no Estado de Goiás, Brazil
| | | | | | | | | |
Collapse
|
44
|
You H, Wang F, Li T, Xu X, Sun Y, Nan Y, Wang G, Hou J, Duan Z, Wei L, Jia J, Zhuang H. Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2022). J Clin Transl Hepatol 2023; 11:1425-1442. [PMID: 37719965 PMCID: PMC10500285 DOI: 10.14218/jcth.2023.00320] [Citation(s) in RCA: 64] [Impact Index Per Article: 32.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/09/2023] [Revised: 08/02/2023] [Accepted: 08/03/2023] [Indexed: 09/19/2023] Open
Abstract
To facilitate the achieving of the goal of "eliminating viral hepatitis as a major public health threat by 2030" set by the World Health Organization, the Chinese Society of Hepatology together with the Chinese Society of Infectious Diseases (both are branches of the Chinese Medical Association) organized a panel of experts and updated the guidelines for prevention and treatment of chronic hepatitis B in China (version 2022). With the support of available evidence, this revision of the guidelines focuses on active prevention, large scale testing, and expansion of therapeutic indication of chronic hepatitis B with the aim of reducing the hepatitis B related disease burden.
Collapse
Affiliation(s)
- Hong You
- Beijing Friendship Hospital, Capital Medical University, Beijing, China
| | - Fusheng Wang
- The Fifth Medical Center of PLA General Hospital, Beijing, China
| | - Taisheng Li
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
| | - Xiaoyuan Xu
- Peking University First Hospital, Beijing, China
| | - Yameng Sun
- Beijing Friendship Hospital, Capital Medical University, Beijing, China
| | - Yuemin Nan
- Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
| | | | - Jinlin Hou
- Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
| | - Zhongping Duan
- Beijing You-An Hospital, Capital Medical University, Beijing, China
| | - Lai Wei
- Tsinghua Changgung Hospital, Tsinghua University, Beijing, China
| | - Jidong Jia
- Beijing Friendship Hospital, Capital Medical University, Beijing, China
| | - Hui Zhuang
- Peking University Health Science Center, Beijing, China
| |
Collapse
|
45
|
Iwu-Jaja C, Iwu CD, Jaca A, Wiysonge CS. New Vaccine Introductions in WHO African Region between 2000 and 2022. Vaccines (Basel) 2023; 11:1722. [PMID: 38006054 PMCID: PMC10675678 DOI: 10.3390/vaccines11111722] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2023] [Revised: 11/05/2023] [Accepted: 11/13/2023] [Indexed: 11/26/2023] Open
Abstract
Significant progress has been made in vaccine development worldwide. This study examined the WHO African Region's vaccine introduction trends from 2000 to 2022, excluding COVID-19 vaccines. We extracted data on vaccine introductions from the WHO/UNICEF joint reporting form for 17 vaccines. We examined the frequency and percentages of vaccine introductions from 2000 to 2022, as well as between two specific time periods (2000-2010 and 2011-2022). We analysed Gavi eligible and ineligible countries separately and used a Chi-squared test to determine if vaccine introductions differed significantly. Three vaccines have been introduced in all 47 countries within the region: hepatitis B (HepB), Haemophilus influenzae type b (Hib), and inactivated polio vaccine (IPV). Between 2011 and 2022, HepB, Hib, IPV, the second dose of measles-containing vaccine (MCV2), and pneumococcal conjugate vaccine (PCV) were the five most frequently introduced vaccines. Hepatitis A vaccine has only been introduced in Mauritius, while Japanese encephalitis vaccine has not been introduced in any African country. Between 2000-2010 and 2011-2022, a statistically significant rise in the number of vaccine introductions was noted (p < 0.001) with a significant positive association between Gavi eligibility and vaccine introductions (p < 0.001). Significant progress has been made in the introduction of new vaccines between 2000 and 2022 in the WHO African Region, with notable introductions between 2011 and 2022. Commitments from countries, and establishing the infrastructure required for effective implementation, remain crucial.
Collapse
Affiliation(s)
- Chinwe Iwu-Jaja
- Communicable and Non-Communicable Diseases Cluster, World Health Organization Regional Office for Africa, Brazzaville P.O. Box 06, Congo;
| | - Chidozie Declan Iwu
- School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria 0031, South Africa;
| | - Anelisa Jaca
- Cochrane South Africa, South African Medical Research Council, Cape Town 7505, South Africa;
| | - Charles Shey Wiysonge
- Communicable and Non-Communicable Diseases Cluster, World Health Organization Regional Office for Africa, Brazzaville P.O. Box 06, Congo;
| |
Collapse
|
46
|
Wang C, Zhang S, Zhao J, Wang M, Lu QB, Liu B, Du J, Cui F. Changes and gaps of global and regional disease burden of hepatitis B infection in children younger than 5 years old between 2015 and 2019: A real-world data review. J Med Virol 2023; 95:e29241. [PMID: 38010806 DOI: 10.1002/jmv.29241] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/07/2023] [Revised: 10/11/2023] [Accepted: 11/06/2023] [Indexed: 11/29/2023]
Abstract
Hepatitis B virus (HBV) infection has been declared an ongoing health threat, especially infections among children. We compared and updated the disease burden of HBV infection and the effectiveness of vaccination among children younger than 5 years to offer indications for hepatitis B prevention across the world. The country-level data on the prevalence of hepatitis B surface antigen (HBsAg), the coverages of hepatitis B vaccine birth-dose (HepB-BD), three-dose series (HepB3), income level, population density/size, and human development index were collected from open access databases including WHO, UNICEF, and World Bank. Comparison of the prevalence of HBsAg under 5 years old between 2015 and 2019 based on vaccination coverages was conducted by the gamma generalized linear mixed model. Globally, more than 6.3 million HBV infections were estimated in children under 5 years in 2019, compared to 10.1 million in 2015 within the 179 countries involved. The pooled average prevalence of HBsAg among children younger than 5 years decreased from 1.4% (95% confidence interval [CI]: 1.1-1.8) to 0.9% (95% CI: 0.7-1.2). The rate difference or rate ratio was -0.5% (95% CI: -0.6% to -0.3%) or 0.51(95% CI: 0.44-0.58), respectively. Countries from the African region or with lower income/population density/human development indexes bore the most significant disease burden of hepatitis B. Higher coverages of hepatitis B vaccine birth-dose or primary series correlated with significant HBsAg prevalence decreases and much-decreased ratio, independently. Hepatitis B prevention among children under 5 years has significantly been achieved while remaining the most life-threatening disease burden, unequally distributed worldwide. The hepatitis B vaccination should be prioritized for all newborns, especially in those resource-constrained countries or regions.
Collapse
Affiliation(s)
- Chao Wang
- Department of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China
- Global Center for Infectious Disease and Policy Research, Peking University, Beijing, China
| | - Sihui Zhang
- Department of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China
| | - Jun Zhao
- Global Center for Infectious Disease and Policy Research, Peking University, Beijing, China
| | - Mingting Wang
- Global Center for Infectious Disease and Policy Research, Peking University, Beijing, China
| | - Qing-Bin Lu
- Department of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China
- Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing, China
| | - Bei Liu
- Department of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China
- Global Center for Infectious Disease and Policy Research, Peking University, Beijing, China
| | - Juan Du
- Global Center for Infectious Disease and Policy Research, Peking University, Beijing, China
- Global Center for Infectious Disease and Policy Research & Global Health and Infectious Diseases Group, Peking University, Beijing, China
| | - Fuqiang Cui
- Department of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China
- Global Center for Infectious Disease and Policy Research, Peking University, Beijing, China
- Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing, China
- Global Center for Infectious Disease and Policy Research & Global Health and Infectious Diseases Group, Peking University, Beijing, China
| |
Collapse
|
47
|
Roma K, Dossaji Z, Haque L, Laeeq T, Gish RG, Brosgart C. Test All for Hepatitis B Virus: Link to Care and Treatment if Quantitative DNA Positive, Vaccinate if Susceptible. Clin Liver Dis 2023; 27:997-1022. [PMID: 37778782 DOI: 10.1016/j.cld.2023.05.009] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/03/2023]
Abstract
Hepatitis B infection affects approximately 262 million people worldwide and is responsible for 900,000 deaths annually. This article reviews the major factors limiting HBV elimination, which includes limited linkage to care and complicated HBV testing and treatment guidelines. The article then provides solutions to these pressing issues.
Collapse
Affiliation(s)
- Katerina Roma
- Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, 1701 West Charleston Boulevard - Suite 230, Las Vegas, NV 89102, USA.
| | - Zahra Dossaji
- Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, 1701 West Charleston Boulevard - Suite 230, Las Vegas, NV 89102, USA
| | - Lubaba Haque
- Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, 1701 West Charleston Boulevard - Suite 230, Las Vegas, NV 89102, USA
| | - Tooba Laeeq
- Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, 1701 West Charleston Boulevard - Suite 230, Las Vegas, NV 89102, USA
| | | | - Carol Brosgart
- Medicine, Biostatistics, and Epidemiology, University of California San Francisco, San Francisco, CA, USA
| |
Collapse
|
48
|
Sheikh D, Staggers KA, Carey J, Keitel WA, Atmar RL, El Sahly HM, Whitaker JA. Delays in Hepatitis B Immunization Series Completion in People With Human Immunodeficiency Virus. Open Forum Infect Dis 2023; 10:ofad543. [PMID: 38033987 PMCID: PMC10686353 DOI: 10.1093/ofid/ofad543] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2023] [Accepted: 10/30/2023] [Indexed: 12/02/2023] Open
Abstract
Background Studies have demonstrated low hepatitis B virus (HBV) vaccine series completion among persons with human immunodeficiency virus (HIV). Methods We conducted a retrospective record review of persons entering HIV care at 2 clinics in Houston, Texas, between 2010 and 2018. Kaplan-Meier curves summarized time to receipt of HBV vaccines for those eligible for vaccination. We estimated the proportions of patients who had received 1, 2, or 3 HBV vaccine doses at 12 and 24 months after entry to care. A Prentice Williams and Peterson total time model was used to evaluate associations between patient characteristics and time to vaccination. Results Of the 5357 patients who entered care, 2718 were eligible for HBV vaccination. After 2 years of follow-up, 51.2% of those eligible had received 1 HBV vaccine, 43.2% had received 2, and 28.4% received 3 vaccines. With adjustment for significant cofactors, patients whose CD4 cell count was ≥200/μL (adjusted hazard ratio [aHR], 1.43 [95% confidence interval (CI), 1.29-1.59]) and transgender patients (1.49 [1.08-2.04]) received any given vaccine dose sooner than those with CD4 cell counts <200/μL or cisgender patients, respectively. Compared with non-Hispanic whites, Hispanic patients were vaccinated sooner (aHR, 1.28 [95% CI, 1.07-1.53]). Those with an active substance use history had a significantly longer time to vaccination than those with no substance use history (aHR, 0.73 [95% CI, .62-.85]). Conclusions Strategies are needed to increase HBV vaccine completion rates in our study population, particularly among those with CD4 cell counts <200/μL or with a substance use disorder.
Collapse
Affiliation(s)
- Daanish Sheikh
- Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA
| | - Kristen A Staggers
- Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas, USA
| | - Jennifer Carey
- Thomas Street Health Center, Harris Health System, Houston, Texas, USA
| | - Wendy A Keitel
- Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA
- Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA
| | - Robert L Atmar
- Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA
| | - Hana M El Sahly
- Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA
- Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA
| | - Jennifer A Whitaker
- Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA
- Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas, USA
| |
Collapse
|
49
|
Solomon-Rakiep T, Olivier J, Amponsah-Dacosta E. Weak Adoption and Performance of Hepatitis B Birth-Dose Vaccination Programs in Africa: Time to Consider Systems Complexity?-A Scoping Review. Trop Med Infect Dis 2023; 8:474. [PMID: 37888602 PMCID: PMC10611266 DOI: 10.3390/tropicalmed8100474] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2023] [Revised: 10/01/2023] [Accepted: 10/11/2023] [Indexed: 10/28/2023] Open
Abstract
The persistent burden of chronic hepatitis B among ≤5-year-old children in Africa suggests missed opportunities for controlling mother-to-child transmission (MTCT) of the hepatitis B virus (HBV). This scoping review maps the evidence base on the risk of HBV MTCT, the status of HBV MTCT mitigation strategies including hepatitis B birth-dose vaccination, and the role of systems complexity on the suboptimal adoption and performance of hepatitis B birth-dose vaccination programs in Africa. Overall, 88 peer-reviewed and grey literature sources published between 2000-2022 were included in this review. The growing evidence base consistently argues for a heightened risk of HBV MTCT amidst the HIV co-epidemic in the region. Without universal HBV screening programs integrated within broader antenatal care services, current selective hepatitis B birth-dose vaccination is unlikely to effectively interrupt HBV MTCT. We underscore critical health systems-related barriers to universal adoption and optimal performance of hepatitis B birth-dose vaccination programs in the region. To better conceptualize the role of complexity and system-wide effects on the observed performance of the program, we propose an adapted systems-based logic model. Ultimately, exploring contextualized complex systems approaches to scaling-up universal hepatitis B birth-dose vaccination programs should form an integral part of the regional research agenda.
Collapse
Affiliation(s)
- Tasneem Solomon-Rakiep
- Health Policy and Systems Division, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town 7925, South Africa;
- Vaccines for Africa Initiative, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town 7925, South Africa
| | - Jill Olivier
- Health Policy and Systems Division, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town 7925, South Africa;
| | - Edina Amponsah-Dacosta
- Vaccines for Africa Initiative, School of Public Health, Faculty of Health Sciences, University of Cape Town, Observatory, Cape Town 7925, South Africa
| |
Collapse
|
50
|
Xi J, Gu Z, Sun C, Chen Z, Zhang T, Chen R, Liu T, Liao H, Zou J, Yang D, Xu Q, Wang J, Wei G, Cheng Z, Lu F, Chen X. A novel hepatitis B virus capsid assembly modulator QL-007 inhibits HBV replication and infection through altering capsid assembly. Antiviral Res 2023; 218:105715. [PMID: 37683938 DOI: 10.1016/j.antiviral.2023.105715] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2023] [Revised: 09/05/2023] [Accepted: 09/05/2023] [Indexed: 09/10/2023]
Abstract
The core protein allosteric modulators (CpAMs) have shown great potential as highly effective antiviral drugs against hepatitis B virus (HBV) in preclinical studies and clinical trials. In this study, we evaluated a small molecule compound called QL-007, which could potentially influence capsid assembly, using HBV replicated and susceptible cell models as well as mice infected with rAAV-HBV. QL-007 significantly inhibited HBV replication in a dose-dependent manner both in vitro and in vivo, resulting in significant decreases in HBV DNA, 3.5 kb HBV RNA and HBeAg. Furthermore, QL-007 not only induced the formation of misshaped Cp149 capsids but also possessed the capability to disassemble HBV capsids. It is noteworthy that QL-007 effectively reduced cccDNA biosynthesis in de novo infections. Mechanistically, QL-007 blocked the encapsidation of pgRNA and induced aberrant polymers assembly at concentrations ≥100 nM, while having no impact on the stability of core proteins. In conclusion, our findings underscore the potential of QL-007 as an effective agent against HBV replication and introduce it as a novel CpAM for the antiviral treatment of chronic hepatitis B.
Collapse
Affiliation(s)
- Jingyuan Xi
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China; Department of Clinical Laboratory Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China
| | - Zhiqiang Gu
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Chunyan Sun
- Department of Nonclinical Development, Qilu Pharmaceutical Co, Ltd, 243 Gong Ye Bei Road, Jinan, Shandong, 250100, China
| | - Zimin Chen
- R&D Department, Xiamen Innobiomax Biotechnology Co, Ltd, 126 Xin Yuan Road, Xiamen, Fujian, 361022, China
| | - Ting Zhang
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Ran Chen
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China; Institute of Human Virology, Key Laboratory of Tropical Disease Control of Ministry of Education, Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou, Guangdong, 510080, China
| | - Tianyu Liu
- Medical Isotopes Research Center, Department of Radiation Medicine, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Hao Liao
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China; Department of Clinical Laboratory, Shenzhen Third People's Hospital, Southern University of Science and Technology, National Clinical Research Center for Infectious Diseases, Shenzhen, 518112, China
| | - Jun Zou
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Danli Yang
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Qiang Xu
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Jie Wang
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Guochao Wei
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China
| | - Zhe Cheng
- Department of Nonclinical Development, Qilu Pharmaceutical Co, Ltd, 243 Gong Ye Bei Road, Jinan, Shandong, 250100, China.
| | - Fengmin Lu
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China; Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Peking University People's Hospital, Beijing, 100044, China.
| | - Xiangmei Chen
- Department of Microbiology & Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, 100191, China.
| |
Collapse
|