Joshi, NKumar, ASreenivas, D VPalan, SNagarjuna Kumar, Y R2000-04-172009-05-292000-04-172009-05-292000-04-17Joshi N, Kumar A, Sreenivas DV, Palan S, Nagarjuna Kumar YR. Safety and immunogenicity of indigenous recombinant hepatitis B vaccine (Shanvac-B) in comparison with commercially available vaccine. Indian Journal of Gastroenterology. 2000 Apr-Jun; 19(2): 71-3http://imsear.searo.who.int/handle/123456789/65759AIM: To assess the clinical safety, reactogenicity and immunogenicity of an indigenously developed recombinant hepatitis B vaccine (Shanvac-B; Shantha Biotechnics) and to compare it with another commercially available vaccine (Engerix-B, SmithKline Beecham) in healthy adults. METHODS: 120 healthy adults randomLy received 20 micrograms of either Engerix-B (Group A; n = 61) or Shanvac-B (Group B; n = 59) in 0, 1, 2 months schedule. Anti HBs was assessed using commercially available AUSAB kits (Abbott Laboratories) one month after each dose. RESULTS: Protective seroconversion rates after first, second and third dose were 10%, 62.7% and 91.4%, respectively in Group A and 22.4%, 68.9% and 96.4% in Group B, respectively. The geometric mean titer (GMT) after the third dose was significantly high in Group B (419 mIU/mL) than in Group A (140 mIU/mL; p < 0.001). The GMT was significantly higher in women in both the groups. The indigenous vaccine was found to be clinically safe and well tolerated without significant side effects. CONCLUSION: The recombinant hepatitis B vaccine (Shanvac-B) developed in India is safe, well tolerated, and highly immunogenic, with high seroconversion and GMT response.engAdultChi-Square DistributionEnzyme-Linked Immunosorbent AssayFemaleHepatitis Antibodies --immunologyHepatitis B --prevention & controlHepatitis B Vaccines --administration & dosageHumansMaleRecombinant Proteins --administration & dosageVaccines, DNA --administration & dosageClinical Trial