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

• 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
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2006.02.008

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.