title: Clinical experience with an inactivated hepatitis A vaccine.
abstract: Clinical trials of an inactivated hepatitis A vaccine have encompassed 104 studies completed by December 1993 in 27 countries. Studies involved 50,677 subjects and administration of > 120,000 vaccine doses. Results show that the vaccine is safe, clinically well-tolerated, and highly immunogenic in all age groups. A seroconversion rate of 100% is achieved 1 month after primary vaccination. Vaccine-induced antibody titers persist after a primary vaccination course for > or = 1 year with a single dose of 1440 ELISA units (EL.U.) in adults and after two doses of 360 EL.U. in children. A booster dose 6-12 months after the first vaccine dose induces very high antibody titers, which according to a mathematical model, are expected to protect against hepatitis A for > 20 years. The vaccine is equally immunogenic when administered simultaneously with other traveler vaccines, therefore enabling flexible and convenient vaccination against hepatitis A.
authors.affiliation: SmithKline Beecham Biologicals, Rixensart, Belgium.
authors.forename: R
authors.initials: R
authors.lastname: Clemens
authors.forename: A
authors.initials: A
authors.lastname: Safary
authors.forename: A
authors.initials: A
authors.lastname: Hepburn
authors.forename: C
authors.initials: C
authors.lastname: Roche
authors.forename: W J
authors.initials: WJ
authors.lastname: Stanbury
authors.forename: F E
authors.initials: FE
authors.lastname: André
mesh_terms: D000328:Adult; D002648:Child; D002986:Clinical Trials as Topic; D015658:HIV Infections / Q000150:complications; D006506:Hepatitis A / Q000150:complications / Q000517:prevention & control*; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D017957:Hepatitis A Virus, Human / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000097:blood; D006801:Humans; D010865:Pilot Projects; D014195:Travel; D014612:Vaccines / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D014612:Vaccines; D015164:Vaccines, Inactivated; D014761:Viral Hepatitis Vaccines