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Recombinant‐yeast‐derived hepatitis b vaccine in healthy adults: Safety and two‐year immunogenicity of early investigative lots of vaccine
Author(s) -
Butterly Lynn,
Watkins Eloise,
Dienstag Jules L.
Publication year - 1989
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.1890270217
Subject(s) - immunogenicity , virology , medicine , vaccination , titer , hepatitis b vaccine , antibody , hepatitis a vaccine , recombinant dna , immunology , hepatitis b , biology , hepatitis b virus , virus , biochemistry , hbsag , gene
We tested the safety and long‐term immunogenicity of two of the early investigative lots of a recombinant‐yeast‐derived hepatitis B vaccine in immunocompetent adults. Three 10‐μg doses of recombinant hepatitis B vaccine (Merck Sharp & Dohme Research Laboratories, West Point, PA) were administered by deltoid intramuscular injection at time 0, 1, and 6 months to 65 seronegative adult health workers. Following a complete three‐injection course, 98% of vaccinees acquired anti‐HBs, 97% at levels >10 mlU/ml, and 95% maintained such “protective” antibody levels at 1 year. At 2 years, 93% retained antibody, but only 68% had levels >10 mlU/ml. In those who responded to vaccination by achieving any detectable level of antibody, the peak geometric mean titer of anti‐HBs, measured at 9 months, was 741 ± 6 mlU/ml the geometric mean titer fell to 348 ± 6 at 1 year and to 66 ± 7 at 2 years. Side effects were trivial, and levels of yeast antibody, as measured by radioimmunoassay, were not changed from prevaccine levels. No serious adverse effects were encountered, and neither type B nor non‐B hepatitis occurred in any vaccinee. These findings demonstrate that the recombinant yeast hepatitis B vaccine is safe and immunogenic but that 10 μg of the early investigative lots of the recombinant vaccine is less immunogenic than 20 μg of the plasma‐derived vaccine. Recipients of early investigative vaccine lots should be considered for booster vaccination with currently available, more immunogenic vaccine lots.