Randomized Clinical Trial Comparing Hepatitis B Vaccine Administered by 0, 6 and 14 Week versus 6, 10 and 14 Week Schedule in Healthy Infants

OBJECTIVE: This randomized, single-blinded trial was carried out to compare the sero-efficacy of hepatitis B vaccine administered to healthy infants by either of two schedules-birth, 6, 14 weeks or 6, 10 and 14 weeks. METHODS: The 74 infants born to HbsAg-negative mothers were randomized to receive recombinant hepatitis B vaccine at 0, 6 and 14 weeks (Group A) or 6, 10 and 14 weeks (Group B). Serum anti-HBs antibody titer was measured before the first dose and 6 months after the third dose by laboratory personnel blinded to the intervention. All participants received other vaccines as per the national immunization schedule. RESULTS: At 6 months after the third dose sero-conversion was 100% in both groups. A total of 97.3% of subjects in Group A were sero protected (>10 mIUml(-1)) with geometric mean titer (GMT) of 113.78 mIUml(-1) and 94.6% in Group B (GMT 107.04 mIUml(-1)) [p = 0.8]. CONCLUSION: Hepatitis B vaccination by 0, 6 and 14 weeks and 6, 10 and 14 weeks schedules are comparable in terms of sero-efficacy.