R Raz1, R Koren, D Bass. 1. Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel. raz_r@clalit.org.il
Abstract
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 HBV 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--BioHep, 10 micrograms dose, to a licensed vaccine containing only the S-protein component--Engerix-B, 20 micrograms 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. Immunogenicity was tested by measuring anti-hepatitis B surface antibody. RESULTS: One month after the third injection, 98% of the BioHep subjects were found to be seroprotected vs. 85.1% of the Engerix-B group. In addition, the geometric mean titers were 2,203 mIU/ml and 326 mIU/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: BioHep, a novel recombinant HBV vaccine containing S, 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.
RCT Entities:
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 HBV 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--BioHep, 10 micrograms dose, to a licensed vaccine containing only the S-protein component--Engerix-B, 20 micrograms 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. Immunogenicity was tested by measuring anti-hepatitis B surface antibody. RESULTS: One month after the third injection, 98% of the BioHep subjects were found to be seroprotected vs. 85.1% of the Engerix-B group. In addition, the geometric mean titers were 2,203 mIU/ml and 326 mIU/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: BioHep, a novel recombinant HBV vaccine containing S, 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.
Authors: Timo Vesikari; Adam Finn; Pierre van Damme; Isabel Leroux-Roels; Geert Leroux-Roels; Nathan Segall; Azhar Toma; Gerald Vallieres; Ronnie Aronson; Dennis Reich; Samir Arora; Peter J Ruane; Clancy L Cone; Michael Manns; Catherine Cosgrove; Saul N Faust; Maheshi N Ramasamy; Nathalie Machluf; Johanna N Spaans; Bebi Yassin-Rajkumar; David Anderson; Vlad Popovic; Francisco Diaz-Mitoma Journal: JAMA Netw Open Date: 2021-10-01