A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant

Thomas C. Heineman, Mary Lou Clements-Mann, Gregory A. Poland, Robert M. Jacobson, Allen E. Izu, Doreen Sakamoto, Joseph Eiden, Gary A. Van Nest, Henry H. Hsu

Research output: Contribution to journalArticle

88 Scopus citations

Abstract

The safety and immunogenicity of a novel hepatitis B virus (HBV) vaccine containing recombinant PreS2 and S antigens combined with MF59 adjuvant (HBV/MF59) was evaluated in healthy adults (N = 230) who were randomized to receive 2 or 3 immunizations of either the study vaccine or a licensed control vaccine (Recombivax HB®). After a single immunization, 105 of 118 (89%) recipients of HBV/MF59 achieved protective serum levels of anti-HBs antibody (> 10 mIU/ml), compared with 13 of 110 (12%) recipients of licensed vaccine (P < 0.001). The geometric mean titer (GMT) after 2 doses of HBV/MF59 given 2 months apart (13,422 mIU/ml) was more than 5-fold higher than that following 3 doses of licensed vaccine given over 6 months (2,346 mIU/ml; P < 0.001). The GMT following 3 injections of HBV/MF59 (249,917 mIU/ml) was 100- fold higher than licensed vaccine (P < 0.001). Anti-PreS2 antibodies were elicited in over 90% of the subset of HBV/MF59 recipients tested. Both vaccines were well tolerated; transient, mild-to-moderate local inflammation was the major postinjection reaction.

Original languageEnglish (US)
Pages (from-to)2769-2778
Number of pages10
JournalVaccine
Volume17
Issue number22
DOIs
StatePublished - Jul 16 1999

Keywords

  • Adjuvant
  • Clinical trials
  • Hepatitis B vaccine
  • Immunologic

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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    Heineman, T. C., Clements-Mann, M. L., Poland, G. A., Jacobson, R. M., Izu, A. E., Sakamoto, D., Eiden, J., Van Nest, G. A., & Hsu, H. H. (1999). A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant. Vaccine, 17(22), 2769-2778. https://doi.org/10.1016/S0264-410X(99)00088-2