Safety and immunogenicity of indigenous recombinant hepatitis B vaccine (Shanvac-B) in comparison with commercially available vaccine.
OBJECTIVE
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.


CONCLUSIONS
The recombinant hepatitis B vaccine (Shanvac-B) developed in India is safe, well tolerated, and highly immunogenic, with high seroconversion and GMT response.
Joshi
N
N
Department of Gastroenterology, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad.
Kumar
A
A
Sreenivas
D V
DV
Palan
S
S
Nagarjuna Kumar
Y R
YR
D000328:Adult; D016009:Chi-Square Distribution; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006508:Hepatitis Antibodies / Q000276:immunology; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage; D019444:Vaccines, DNA / Q000008:administration & dosage*
D006508:Hepatitis Antibodies; D017325:Hepatitis B Vaccines; D011994:Recombinant Proteins; D019444:Vaccines, DNA