Comparative multicentre study of the immunogenicity of different hepatitis B vaccines in healthy volunteers.
In a comparative study of the immunogenicity of different hepatitis B vaccines, 339 healthy seronegative adults at three different centres were randomly allocated to receive either three doses of a yeast-derived vaccine at one of three different dose levels (10, 20, or 40 micrograms; SmithKline Biologicals) or one of two commercial plasma-derived vaccines at standard dose levels (5 micrograms, Institut Pasteur Production or 20 micrograms, Merck Sharp & Dohme). The subjects were inoculated intramuscularly in the deltoid region according to a 0, 1, and 6 month schedule. No severe or serious adverse reactions attributed to any of the vaccines were observed. One month after the third vaccine dose, seroconversion rates ranged from 95% to 100% in all groups with only 6 subjects failing to seroconvert. Although there were no statistically significant intra-centre differences in antibody levels, the Tours/Chateauroux groups generally attained higher antibody levels than those from Limoges for the same yeast-derived vaccine dose. This unexplained difference between centres was not found for the plasma-derived vaccines. Older subjects responded less well than younger ones and females attained higher antibody levels than did males. The yeast-derived vaccine is comparable to the two commercially available plasma-derived vaccines in terms of reactogenicity and immunogenicity.
Goudeau
A
A
Laboratoire de Virologie, CHU Bretonneau, Tours, France.
Denis
F
F
Mounier
M
M
Dubois
F
F
Klein
J
J
Godefroy
A
A
Ballet
M
M
Mountij
A
A
D000328:Adult; D000941:Antigens / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant / Q000276:immunology; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D012441:Saccharomyces cerevisiae / Q000235:genetics; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000627:therapeutic use*
D000941:Antigens; D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies; D014614:Vaccines, Synthetic