title: Safety and immunogenicity of an inactivated hepatitis A candidate vaccine in healthy adult volunteers.
abstract: The reactogenicity and immunogenicity of a formaldehyde-inactivated hepatitis A vaccine have been investigated. Three different dose levels of vaccine (180, 360 and 720 ELISA units) were administered to healthy volunteers according to a 0, 1, 2 and 12 month schedule. The vaccine was safe and well tolerated. Reactions observed following vaccination were essentially mild and were not dependent upon the quantity of antigen administered. All subjects had measurable titres of anti-HAV antibodies after the full vaccination course; the immune response to the vaccine was dose-related. Antibody titres in vaccinees at month 13 were between 60- and 190-fold higher than those observed in a group of subjects given anti-HAV immunoglobulin.
authors.affiliation: Institute of Specific Prophylaxis and Tropical Medicine, University of Vienna, Austria.
authors.forename: G
authors.initials: G
authors.lastname: Wiedermann
authors.forename: F
authors.initials: F
authors.lastname: Ambrosch
authors.forename: H
authors.initials: H
authors.lastname: Kollaritsch
authors.forename: H
authors.initials: H
authors.lastname: Hofmann
authors.forename: C
authors.initials: C
authors.lastname: Kunz
authors.forename: E
authors.initials: E
authors.lastname: D'Hondt
authors.forename: A
authors.initials: A
authors.lastname: Delem
authors.forename: F E
authors.initials: FE
authors.lastname: André
authors.forename: A
authors.initials: A
authors.lastname: Safary
authors.forename: J
authors.initials: J
authors.lastname: Stéphenne
mesh_terms: D000293:Adolescent; D000328:Adult; D000917:Antibody Formation / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D005069:Evaluation Studies as Topic; D005260:Female; D005557:Formaldehyde / Q000494:pharmacology; D006507:Hepatovirus / Q000276:immunology*; D006801:Humans; D007116:Immunization, Passive; D008297:Male; D008875:Middle Aged; D014611:Vaccination / Q000009:adverse effects / Q000592:standards; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology* / Q000494:pharmacology; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000494:pharmacology; D014771:Virion / Q000276:immunology
chemical_list: D015164:Vaccines, Inactivated; D014761:Viral Hepatitis Vaccines; D005557:Formaldehyde