Immunogenicity of a new, low-cost recombinant hepatitis B vaccine derived from Hansenula polymorpha in adults

Immunogenicity of a new, low-cost recombinant hepatitis B vaccine derived from Hansenula polymorpha in adults

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 using Hansenula polymorpha yeast. We decided to assess the immunogenicity, and reactogenicity of t...

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Bibliographic Details
Published in:Vaccine Vol. 24; no. 17; pp. 3457 - 3460
Main Authors: Kulkarni, P.S., Raut, S.K., Patki, P.S., Phadke, M.A., Jadhav, S.S., Kapre, S.V., Dhorje, S.P., Godse, S.R.
Format: Journal Article
Language:English
Published: Oxford Elsevier Ltd 24-04-2006
Elsevier
Subjects:
Adult
Adults
Applied microbiology
Biological and medical sciences
Cost
Female
Fundamental and applied biological sciences. Psychology
GeneVac-B
Hansenula polymorpha
Hepatitis B Antibodies - blood
Hepatitis B vaccine
Hepatitis B Vaccines - adverse effects
Hepatitis B Vaccines - economics
Hepatitis B Vaccines - immunology
Hepatitis B virus
Human viral diseases
Humans
Immunogenicity
Infectious diseases
Male
Medical sciences
Microbiology
Middle Aged
Miscellaneous
Mycology
Pichia - genetics
Prospective Studies
Reactogenicity
Recombinant Proteins - immunology
Vaccination
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vaccines, Synthetic - immunology
Viral diseases
Viral hepatitis
Hepatitis B vaccine
GeneVac-B
Adults
Immunogenicity
Cost
Reactogenicity
Human
Yeast
Toxicity
Hepatic disease
Vaccine
Fungi
Infection
Viral hepatitis B
Viral hepatitis A
Viral disease
Digestive diseases
Adult
Ascomycetes
Hansenula polymorpha
Thallophyta
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Summary: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 using Hansenula polymorpha yeast. We decided to assess the immunogenicity, and reactogenicity of this vaccine in a large adult population. Seven hundred eighty-eight adults subjects (age: 19–57 years, male:female ratio 35:1) received three 20 μg doses of a H. 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 1 mIU/ml, and seroprotective if more than 10 mIU/ml. 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 443 mIU/ml (95% CI 407–482). Seroprotection was 96% in age group <40 years, while the same was 91% in >40 years group (Odd's ratio—2.9100, Z value—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. Three standard doses of the H. 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.
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ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2006.02.008