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

The safety and immunogenicity of a novel hepatitis B virus (HBV) vaccine co ntaining recombinant PreS2 and S antigens combined with MF59 adjuvant (HBV/ MF59) was evaluated in healthy adults (N=230) who were randomized to receiv e 2 or 3 immunizations of either the study vaccine or a licensed control va ccine (Recombivax HB(R)). After a single immunization, 105 of 118 (89%) rec ipients 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 follow ing 3 doses of licensed vaccine given over 6 months (2,346 mIU/ml; P < 0.00 1). The GMT following 3 injections of HBV/MF59 (249,917 mIU/ml) was 100-fol d higher than licensed vaccine (P < 0.001), Anti-PreS2 antibodies were elic ited in over 90% of the subset of HBV/MF59 recipients tested, Both vaccines were well tolerated; transient, mild-to-moderate local inflammation was th e major postinjection reaction.(C) 1999 Elsevier Science Ltd. All rights re served.