title: A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant.
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.
authors.affiliation: Division of Infectious Diseases and Immunology, St. Louis University, MO 63110-0250, USA.
authors.forename: T C
authors.initials: TC
authors.lastname: Heineman
authors.forename: M L
authors.initials: ML
authors.lastname: Clements-Mann
authors.forename: G A
authors.initials: GA
authors.lastname: Poland
authors.forename: R M
authors.initials: RM
authors.lastname: Jacobson
authors.forename: A E
authors.initials: AE
authors.lastname: Izu
authors.forename: D
authors.initials: D
authors.lastname: Sakamoto
authors.forename: J
authors.initials: J
authors.lastname: Eiden
authors.forename: G A
authors.initials: GA
authors.lastname: Van Nest
authors.forename: H H
authors.initials: HH
authors.lastname: Hsu
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007108:Immune Tolerance; D007117:Immunization, Secondary; D008297:Male; D011136:Polysorbates / Q000009:adverse effects / Q000032:analysis*; D013185:Squalene / Q000009:adverse effects / Q000032:analysis* / Q000276:immunology*; D013997:Time Factors
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D017325:Hepatitis B Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene