title: Safety and immunogenicity of hepatitis A vaccine in patients with chronic liver disease.
abstract: Acute hepatitis A superimposed on chronic liver disease (CLD) has been associated with severe or fulminant hepatitis. An open, multicenter study was performed to compare the safety and immunogenicity of an inactivated hepatitis A vaccine in patients with CLD with that in healthy subjects. A secondary objective was to compare the safety of the hepatitis A vaccine with that of a commercial hepatitis B vaccine in subjects with chronic hepatitis C. A total of 475 subjects over the age of 18 years were enrolled into 1 of 5 groups according to history, serological data, and previous diagnosis. Patients in groups 1 (healthy adults), 2 (chronic hepatitis B), 3 (chronic hepatitis C), and 5 (other CLD not caused by viral hepatitis) were vaccinated with two doses of inactivated hepatitis A vaccine, 6 months apart. Patients in group 4 (chronic hepatitis C) received 3 doses of a recombinant hepatitis B vaccine, according to a 0-, 1-, and 6-month schedule. Local injection-site symptoms were the most common reactions reported following vaccination in all groups (35.5% of all doses), with the hepatitis B vaccine eliciting fewer injection-site symptoms than the hepatitis A vaccine (19.8% compared with 37.5%). Although a higher percentage of healthy subjects (93%) seroconverted after a single dose of the hepatitis A vaccine than did subjects with chronic hepatitis C (73.7%) or CLD of nonviral etiologies (83.1%), more than 94% of all vaccinees were seropositive for anti-HAV after the complete vaccination course. At each time point, a lower geometric mean concentration of anti-HAV was observed for each group of CLD patients compared with the healthy control subjects. In conclusion, hepatitis A vaccine was well tolerated and induced a satisfactory immune response in patients with chronic hepatitis B, chronic hepatitis C, and miscellaneous CLD.
authors.affiliation: Stanford University Medical Center, California, USA.
authors.forename: E B
authors.initials: EB
authors.lastname: Keeffe
authors.forename: S
authors.initials: S
authors.lastname: Iwarson
authors.forename: B J
authors.initials: BJ
authors.lastname: McMahon
authors.forename: K L
authors.initials: KL
authors.lastname: Lindsay
authors.forename: R S
authors.initials: RS
authors.lastname: Koff
authors.forename: M
authors.initials: M
authors.lastname: Manns
authors.forename: R
authors.initials: R
authors.lastname: Baumgarten
authors.forename: M
authors.initials: M
authors.lastname: Wiese
authors.forename: M
authors.initials: M
authors.lastname: Fourneau
authors.forename: A
authors.initials: A
authors.lastname: Safary
authors.forename: R
authors.initials: R
authors.lastname: Clemens
authors.forename: D S
authors.initials: DS
authors.lastname: Krause
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D005260:Female; D022362:Hepatitis A Vaccines; D017957:Hepatitis A Virus, Human / Q000276:immunology*; D006509:Hepatitis B / Q000276:immunology; D006526:Hepatitis C / Q000276:immunology; D006801:Humans; D008107:Liver Diseases / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014611:Vaccination; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects* / Q000276:immunology
chemical_list: D022362:Hepatitis A Vaccines; D014761:Viral Hepatitis Vaccines