Rapid Communication
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World J Gastroenterol. Jun 14, 2007; 13(22): 3084-3089
Published online Jun 14, 2007. doi: 10.3748/wjg.v13.i22.3084
Comparison of three different recombinant hepatitis B vaccines: GeneVac-B, Engerix B and Shanvac B in high risk infants born to HBsAg positive mothers in India
Vijayakumar Velu, Subhadra Nandakumar, Saravanan Shanmugam, Suresh Sakharam Jadhav, Prasad Suryakant Kulkarni, Sadras Panchatcharam Thyagarajan
Vijayakumar Velu, Subhadra Nandakumar, Saravanan Shanmugam, Sadras Panchatcharam Thyagarajan, Department of Medical Microbiology, Dr ALM PGIBMS, University of Madras, Chennai 600113 and National referral Centre for viral hepatitis, India
Vijayakumar Velu, Vaccine Research Centre, Department of Microbiology and Immunology, Emory University, Atlanta, Georgia 30329, United States
Saravanan Shanmugam, Sadras Panchatcharam Thyagarajan, YRG Centre for AIDS Research and Education, VHS campus, Taramani, Chennai 600113, India
Suresh Sakharam Jadhav, Prasad Suryakant Kulkarni, Serum Institute of India Ltd, Pune, India
Author contributions: All authors contributed equally to the work.
Correspondence to: Dr. Sadras Panchatcharam Thyagarajan, YRG Center for AIDS Research and Education, Taramani, Voluntary Health Services, Chennai 600113, India. vvjai2000@yahoo.com
Telephone: +91-44-22542929 Fax: +91-44-22542939
Received: February 15, 2007
Revised: March 10, 2007
Accepted: March 26, 2007
Published online: June 14, 2007
Abstract

AIM: To evaluate a low cost Indian recombinant hepatitis B vaccine GeneVac-B® for its immunogenicity and safety in comparison to Engerix B® and Shanvac B® vaccine in high risk newborn infants born to hepatitis B surface antigen (HBsAg) positive mothers.

METHODS: A total of 158 infants were enrolled in the study. Fifty eight infants were enrolled in the GeneVac-B® group while 50 each were included for Engerix B® and Shanvac B® groups. A three-dose regimen of vaccination; at birth (within 24 h of birth), 1st mo and 6 mo. were adopted with 10 μg dosage administered uniformly in all the three groups. Clinical and immunological parameters were assessed for safety and immunogenicity of the vaccines, in all the enrolled infants.

RESULTS: Successful follow up until seven months of age was achieved in 83% (48/58) for GeneVac-B®, 76% (38/50) and 64% (32/50) for Engerix B® and Shanvac B® groups respectively. 100% seroconversion and seroprotection was achieved in all the three groups of infants. The geometric mean titers of anti-HBs one month after the completion of three dose of vaccination were 90.5, 80.9 and 72.5 mIU/mL in GeneVac-B®, Engerix B® and Shanvac B® vaccine group respectively. Furthermore the level of anti-HBs increases with age of babies who were born to HBsAg positive mothers. The GMT values of anti-HBs were 226.7, 193.9 and 173.6 mIU/mL respectively in GeneVac-B®, Engerix B® and Shanvac B® groups one year after the completion of the three doses of vaccine. No systemic reactions were reported in infants during the entire vaccination process of GeneVac-B® and the other two vaccines. Clinical safety parameters remained within the normal limits throughout the study period.

CONCLUSION: The study concludes that there is no significant difference between the three recombinant hepatitis B vaccines. Administration of these vaccines within 24 h of birth to babies, born to HBsAg positive mothers will reduce the incidence of HBV infection.

Keywords: GeneVac-B, Maternal screening, High risk infants, Infant vaccination