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

doi:10.1016/S0264-410X(99)00088-2

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 journal › Article › peer-review

89 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 language	English (US)
Pages (from-to)	2769-2778
Number of pages	10
Journal	Vaccine
Volume	17
Issue number	22
DOIs	https://doi.org/10.1016/S0264-410X(99)00088-2
State	Published - 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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10.1016/S0264-410X(99)00088-2

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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{\textregistered}). 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.",

keywords = "Adjuvant, Clinical trials, Hepatitis B vaccine, Immunologic",

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T1 - A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant

AU - Heineman, Thomas C.

AU - Clements-Mann, Mary Lou

AU - Poland, Gregory A.

AU - Jacobson, Robert M.

AU - Izu, Allen E.

AU - Sakamoto, Doreen

AU - Eiden, Joseph

AU - Van Nest, Gary A.

AU - Hsu, Henry H.

PY - 1999/7/16

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KW - Adjuvant

KW - Clinical trials

KW - Hepatitis B vaccine

KW - Immunologic

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

Abstract

Keywords

ASJC Scopus subject areas

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