Immunogenicity of a new, low-cost recombinant hepatitis B vaccine derived fromHansenula polymorphain adults

Background Hepatitis B virus (HBV) infection is highly prevalent world over, especially in developing countries. A new recombinant hepatitis B virus (GeneVac-B; Serum Institute of India Ltd.) vaccine is developed usingHansenula polymorphayeast. We decided to assess the immunogenicity, and reactogeni...

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Bibliographic Details
Published in:Vaccine 2006-04, Vol.24 (17), p.3457
Main Authors: Kulkarni, PS, Raut, SK, Patki, PS, Phadke, MA, Jadhav, SS, Kapre, SV, Dhorje, SP, Godse, SR
Format: Article
Language:English
Subjects:
Age
Antigens
Body mass index
Chronic illnesses
Deoxyribonucleic acid
Developing countries
Diabetes
DNA
Gender
Hematology
Hepatitis
Hypertension
Immune response
Immunogenicity
LDCs
Liver cancer
Mortality
Risk factors
Smoking
Studies
Tobacco
Vaccines
Young adults
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Summary:Background Hepatitis B virus (HBV) infection is highly prevalent world over, especially in developing countries. A new recombinant hepatitis B virus (GeneVac-B; Serum Institute of India Ltd.) vaccine is developed usingHansenula polymorphayeast. We decided to assess the immunogenicity, and reactogenicity of this vaccine in a large adult population. Material and methods Seven hundred eighty-eight adults subjects (age: 19-57 years, male:female ratio 35:1) received three 20μg doses of aH. polymorpha-derived recombinant hepatitis B vaccine in months 0, 1, and 6. All the eligible subjects had negative baseline serum HBs Ag, and anti-HBs. The anti-HBs titer was obtained 1 month after the last dose of vaccine and was considered seroconverted if more than 1mIU/ml, and seroprotective if more than 10mIU/ml. Results The seroprotection rate was 96% and seroconversion rate was 97%. Seroconversion and seroprotection rates declined with increasing age. The minimum geometric mean titre of anti HBs was 443mIU/ml (95% CI 407-482). Seroprotection was 96% in age group 40 years group (Odd's ratio--2.9100,Zvalue--2.6183, highly significant). No other factor like smoking, tobacco-chewing, alcohol consumption, chronic diseases, and obesity, affected the immune response. No significant adverse reactions were reported in any of the subjects. Conclusions Three standard doses of theH. polymorpha-derived recombinant HBV vaccine are highly immunogenic and safe in a predominantly male adult population. Young adults respond better with this vaccine. Because of its low cost, the vaccine may be a good choice in prevention of hepatitis B infection.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2006.02.008