Immunogenicity and tolerance of a yeast-derived hepatitis B vaccine in homosexual men.
A yeast-derived recombinant DNA vaccine against hepatitis B was administered to 314 active homosexual men lacking serum markers for hepatitis B virus. Volunteers were vaccinated intramuscularly in the deltoid region at 0, 1, and 6 months with either a 20- or 40-micrograms dose per injection. Serologic tests for syphilis and human immunodeficiency virus were positive in 3.2% and 2.0%, respectively. The overall seroconversion rates for anti-HBs were 35%, 97%, and 98% after the first, second, and third injection, respectively. The geometric mean titres of anti-HBs antibodies at 7 months were 955 IU/l and 2541 IU/l, for the 20 and 40 micrograms doses, respectively. Among 183 completely vaccinated subjects, 97% had an anti-HBs titre greater than 10 IU/l. Tolerance of the vaccine was excellent. Among the 183 subjects followed up for at least 7 months, two volunteers developed HBsAg and anti-HBc within one month of the first vaccine injection and one anti-HBc just before the third dose of vaccine. However, no subject experienced clinical hepatitis or ALT elevations.
Prinsen
H
H
Department of Microbiology, Institute of Tropical Medicine, Antwerp, Belgium.
Goilav
C
C
Safary
A
A
André
F E
FE
Piot
P
P
D000293:Adolescent; D000328:Adult; D000941:Antigens / Q000627:therapeutic use*; D004274:DNA, Recombinant / Q000276:immunology; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis*; D006716:Homosexuality; D006801:Humans; D008297:Male; D008875:Middle Aged; D012441:Saccharomyces cerevisiae / Q000235:genetics; D013997:Time Factors; D014611:Vaccination / Q000009:adverse effects; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*
D000941:Antigens; D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies; D014614:Vaccines, Synthetic