Evaluation of the immunogenicity of a recombinant vaccine against hepatitis B containing S and pre-S2 sequences using two different schedules.

The immunogenicities of hepatitis B virus vaccines containing S and pre-S2 regions were compared using two different schedules of immunization (A: 0-1-2-12 months and B: 0-1-6 months). Two hundred males and females aged 17-22 years were vaccinated with 20 micrograms per dose. The follow-up period was extended up to 13 months. One month after the booster dose anti-HBs were detected in 98.9% of those vaccinated with schedule A and 100% of those vaccinated with schedule B. Geometric mean titres (GMT) of anti-HBs were significantly higher with schedule A than schedule B, reaching GMT of 16269.7 mIU ml-1 and 4372.4 mIU ml-1, respectively, one month after the booster dose. Seroconversion rates for the anti-pre-S2 antibodies one month after the booster dose were 89.4% for schedule A and 76.6% for schedule B. GMT were 157.8 mIU ml-1 and 67.5 mIU ml-1, respectively. We conclude that both vaccines elicit high titres of anti-HBs and anti-pre-S2 antibodies. Immunity lasts longer in schedule A than in schedule B.

RCT Entities:   Population Interventions Outcomes