RESUMO
AIM: To establish the safety and efficacy of an indigenously developed r-hepatitis B vaccine using an accelerated schedule and to highlight the social awareness and commitment in preventing the spreading of hepatitis B virus infection. METHODS: The study was a multicentric, double blind, randomized (3:1) study using three doses of vaccine immunization schedule (20 mug for those above 10 years old and 10 mug for those below 10 years old) on d 0, 30 and 60. One hundred and sixty-six subjects were enrolled (87 males and 76 females aged 5-35 years). The main outcome measure was assessment of immunogenicity and safety. RESULTS: A 100% seroconversion response was observed on the 30(th) d after the 1(st) injection in both the experimental groups. The sero-protection data reported a 41.2-65.6% response on the 30(th) d after the 1(st) injection and reached 100% on the 60(th) d. Descriptive statistical analysis showed a geometric mean titer value of 13.77 mIU/mL in the test (BEVAC) group and 10.95 mIU/mL in the commercial control (ENGERIX-B) group on the 30(th) d after the 1(st) injection. The response on the 60(th) d showed a geometric mean titre value (GMT) of 519.84 mIU/mL in the BEVAC group and 475.46 mIU/mL in the ENGERIX-B group. On the 90(th) d, the antibody titer response was observed to be 2627.58 mIU/mL in the BEVAC group and 2272.72 mIU/mL in the ENGERIX-B group. Two subjects in each group experienced pains at injection site after the first vaccination. A total of six subjects in both groups experienced a solicited adverse reaction, which included pains, swelling and redness at the injection site, three subjects in the group-B had a pain at the injection site after the third dose. No other serious adverse events occurred and no dose-related local or general symptoms were observed during the study. CONCLUSION: The vaccine is safe, efficacious and immunogenic in comparison with the well documented ENGERIX-B.
