title: Reactogenicity and immunogenicity of different lots of a yeast-derived hepatitis B vaccine.
abstract: Several lots of a yeast-derived hepatitis B vaccine at different doses and a 20 micrograms dose of plasma-derived vaccine were tested in young healthy adults and compared with respect to risk of hypersensitivity reactions, reactogenicity, and immunogenicity. No signs of hypersensitivity either pre-existing or vaccine-induced were observed. Reactogenicity was low and similar in all vaccine groups. It was not dose related and unaffected by the number of injections. Immunogenicity was evaluated for a 0, 1, 2, and 12 month vaccination schedule. Seroconversion rates (greater than or equal to 10 IU/l) were not significantly different between the purified yeast- and plasma-derived vaccines one month after the second vaccination whereas the percentage of seroconversion was slightly lower in the groups receiving only partly purified recombinant vaccines. Although geometric mean titres induced by the plasma-derived vaccine were somewhat higher after the first months, the antibody titres induced by the recombinant vaccine were at least as high as those elicited by a plasma-derived vaccine following the booster dose.
authors.affiliation: Institute for Specific Prophylaxis and Tropical Medicine, University of Vienna.
authors.forename: G
authors.initials: G
authors.lastname: Wiedermann
authors.forename: F
authors.initials: F
authors.lastname: Ambrosch
authors.forename: P
authors.initials: P
authors.lastname: Kremsner
authors.forename: C
authors.initials: C
authors.lastname: Kunz
authors.forename: P
authors.initials: P
authors.lastname: Hauser
authors.forename: E
authors.initials: E
authors.lastname: Simoen
authors.forename: F
authors.initials: F
authors.lastname: André
authors.forename: A
authors.initials: A
authors.lastname: Safary
mesh_terms: D000941:Antigens / Q000627:therapeutic use*; D004274:DNA, Recombinant / Q000276:immunology; D004306:Dose-Response Relationship, Immunologic; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000235:genetics / Q000276:immunology; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D012441:Saccharomyces cerevisiae / Q000235:genetics; D013997:Time Factors; D014611:Vaccination / Q000009:adverse effects; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000941:Antigens; D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D014614:Vaccines, Synthetic