• IMA sites
  • IMAJ services
  • IMA journals
  • Follow us
  • Alternate Text Alternate Text
עמוד בית
Thu, 25.07.24

Original Articles

IMAJ | volume

Journal 5, May 2001
pages: 328-332

Safety and immunogenicity of a new mammalian cell-derived recombinant hepatitis B vaccine containing PR-S1 and PRE-S2 antigens in adults

    Summary

    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.

    Legal Disclaimer: The information contained in this website is provided for informational purposes only, and should not be construed as legal or medical advice on any matter.
    The IMA is not responsible for and expressly disclaims liability for damages of any kind arising from the use of or reliance on information contained within the site.
    © All rights to information on this site are reserved and are the property of the Israeli Medical Association. Privacy policy

    2 Twin Towers, 35 Jabotinsky, POB 4292, Ramat Gan 5251108 Israel