A multi-center controlled study of rapid hepatitis B vaccination using a novel triple antigen recombinant vaccine.

Hepatitis B vaccines have been available for 20 years, however, the disease still remains a global problem. Clearly, the protection of at-risk groups could be improved if a more potent vaccine with a shorter vaccination regimen were available. Hepacare is new recombinant vaccine, which contains three of the surface antigens of the HB virus and has higher immunogenicity than present single antigen (HBsAg only) vaccines. This study evaluates the potential for developing seroprotection rapidly and the viability of a 1 month/two dose regimen. A total of 400 adult subjects were vaccinated using either the present accelerated 2 month/three dose regimen of Engerix-B or a 1 month/two dose regimen of a novel triple antigen vaccine (Hepacare). Both vaccines were well tolerated. Four weeks after a single dose, the seroprotective rates for Engerix-B and the triple antigen vaccine were 5 and 17%, respectively. By month 2, 4 weeks after two doses of vaccine, it was 38 and 61%. Finally by month 3, 4 weeks after a third dose of Engerix-B or placebo, respectively, the seroprotection rates were 71 and 82%. The geometric mean titres (GMTs), of these responders was then 119 and 120 IU/l, respectively. Both vaccines were well tolerated. At all points up to and including 3 months after beginning vaccination, the novel 1 month/two dose regimen of Hepacare was significantly more effective in producing seroporotective titres than the 2 month/three dose regimen of Engerix-B (P = 0.001).

RCT Entities:   Population Interventions Outcomes