Rapid Communication
Copyright ©2005 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 7, 2005; 11(45): 7165-7168
Published online Dec 7, 2005. doi: 10.3748/wjg.v11.i45.7165
Evaluation of immunogenicity and reactogenicity of recombinant DNA hepatitis B vaccine produced in India
Zahid Hussain, Syed S Ali, Syed A Husain, Mohammad Raish, Deepika R Sharma, Premashis Kar
Zahid Hussain, Premashis Kar, PCR Hepatitis Laboratory, Department of Medicine, Maulana Azad Medical College, New Delhi 110002, India
Syed S Ali, Deepika R Sharma, Panacea Biotec Ltd, Industrial Estate, Mathura Road, New Delhi 110044, India
Zahid Hussain, Syed A Husain, Mohammad Raish, Human Genetics Laboratory, Department of Biosciences, Jamia Millia Islamia, New Delhi 110025, India
Author contributions: All authors contributed equally to the work.
Supported by the Panacea Biotec Limited, New Delhi 110044, India
Correspondence to: Dr Premashis Kar, Department of Medicine, Maulana Azad Medical College, New Delhi 110002, India. pkar@vsnl.com
Telephone: +91-11-23230132 Fax: +91-11-23230132
Received: November 23, 2004
Revised: January 23, 2005
Accepted: January 26, 2005
Published online: December 7, 2005

AIM: (1) To gain information on immune responses to an accelerated schedule of 0, 1, and 2 mo in paramedical staff and BDS students who are at an increased risk of getting hepatitis B infection and come under high risk groups. (2) To assess the efficacy and safety of Enivac-HB in different age groups, using genetically modified yeast strain Pichia pastoris, a new recombinant hepatitis B vaccine developed and manufactured in India.

METHODS: A prospective, comparative, and single blinded trial of rapid (0, 1, and 2 mo) hepatitis B immunization schedulewas reported. A total of three hundred and seven (212 females and 95 males) healthy volunteers divided into three age groups (18-29, 30-39, and 40-49) were enrolled after screening for markers of hepatitis B. All the volunteers received 20 mg of the vaccine intramuscularly at 0, 1, and 2 mo.

RESULTS: Geometric mean titers were calculated pre and post vaccination. Before immunization the GMT was 0.0124 mIU/mL. One month after the administration of the third dose of recombinant vaccine 296/307 (96.5%) subjects achieved seroprotective levels of anti-HBs. The geometric mean anti-HBs titers achieved after one month of the third dose was 2 560.0 mIU/mL. The geometric mean anti-HBs titer of males was 2 029.0 mIU/mL, while that of the females was 2 759.0 mIU/mL. In the age group of 18-29 years, anti-HBs titer was 3 025.0 mIU/mL, while that in the age group of 30-39 years was 2 096.0 mIU/mL. In third age group of 40-49 years, anti-HBs titer was 1 592.0 mIU/mL. Hyper-responses (anti-HBs≥100 mIU/mL) were shown in 88.0% (271/307) of subjects. Eleven (3.5%) subjects responded poorly to the vaccine in the age group of 40-49 years. There was only mild pain at the site of injection otherwise there were no other adverse drug reactions (ADRs).

CONCLUSION: This vaccine (Enivac-HB) is safe and efficacious, providing significant protection after the third dose and rapid hepatitis B immunization schedule of 0, 1, and 2 mo can be recommended whenever rapid protection is the goal.

Keywords: Enivac-HB, Pichia pastoris, Anti-HBs antibody, Hepatitis B vaccine