Background: Previous data showed that new recombinant hepatitis B virus vaccine, which contains the S-protein component of the HBV surface together with the Pre-S1 and Pre-S2, is considerably more immunogenic than a second-generation recombinant I-IBV vaccine.
Objectives:To compare the immunogenicity and safety of a novel recombinant HBV vaccine S1, Pre-S1 and Pre-S2 protein components of the hepatitis B surface antigen - BioTM
HepTM 10 לg dose, to a licensed vaccine containing only the S-protein component - Engerix-B, 20 לg dose.
Methods: A prospective randomized study included 524 adults - 260 in the Bio-Hep group and 264 in the Engerix-B group. Both vaccines were administered in a three-dose regimen given at 0, 1 and 6 months, and adverse events were recorded on a diary card 5 days after each vaccination. lmmunogenicity was tested by measuring anti-hepatitis B surface antibody.
Results: One month after the third injection, 98% of the BioHepTM subjects were found to be seroprotected vs. 85.1% of the Engerix-B group. In addition, the geometric mean titers were 2,203 mlU/ml and 326 mlU/ml in the Bio-Hep-B and Engerix-B groups respectively. An immunogenic advantage of Bio-Hep-B was suggested by the rapid onset of antibody response - 66.5% were seroconverted one month after the first injection as compared to 19.3% in the Engerix-B group. No unexpected adverse events were observed, and the recorded events were mild in both groups.
Conclusions: BioHepTM, a novel recombinant HBV vaccine containing 5, Pre-S1 and Pre-S2 protein components. at a lower dose, is safe and more immunogenic than the conventional HBV vaccine that contains only S protein.