title: Safety and immunogenicity of an inactivated hepatitis A vaccine: effect of dose and vaccination schedule.
abstract: The safety and immunogenicity of three doses (360 ELISA units [EU], 720 EU, and 1440 EU) and four immunization schedules (0, 1, and 2; 0, 1, and 6; 0, 1, and 12; 0, 2, and 4 months) of an inactivated hepatitis A vaccine were investigated in 80 healthy adult volunteers. Adverse effects were mild and comparable to those in a control group given hepatitis B vaccine. Antibody levels presumed to be protective (> or = 20 mIU/mL) were achieved after one injection in 90% of vaccinees given 360 and 720 EU and in 100% given 1440 EU. After two injections, 100% of vaccinees seroconverted regardless of the dose of vaccine given. All vaccine schedules were highly immunogenic. The accelerated and high-dose schedule could be useful for people who need to be rapidly immunized. The 12-month schedule induced very high levels of anti-hepatitis A virus but had problems with compliance. The 0-, 2-, and 4-month schedule produced higher antibody levels than the conventional 0-, 1-, and 6-month schedule (P = .016). This suggests that the hepatitis A vaccine could be incorporated into existing pediatric vaccine schedules.
authors.affiliation: Dept. of Medicine, St. Louis University School of Medicine, MO 63104.
authors.forename: T U
authors.initials: TU
authors.lastname: Westblom
authors.forename: S
authors.initials: S
authors.lastname: Gudipati
authors.forename: C
authors.initials: C
authors.lastname: DeRousse
authors.forename: B R
authors.initials: BR
authors.lastname: Midkiff
authors.forename: R B
authors.initials: RB
authors.lastname: Belshe
mesh_terms: D000293:Adolescent; D000328:Adult; D002460:Cell Line; D005260:Female; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control*; D022362:Hepatitis A Vaccines; D006801:Humans; D008297:Male; D008875:Middle Aged; D012449:Safety; 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: D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated; D014761:Viral Hepatitis Vaccines