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Safety and immunogenicity of hepatitis A vaccine in patients with chronic liver disease
Author(s) -
Keeffe Emmet B.,
Iwarson Sten,
McMahon Brian J.,
Lindsay Karen L.,
Koff Raymond S.,
Manns Michael,
Baumgarten Renate,
Wiese Manfred,
Fourneau Marc,
Safary Assad,
Clemens Ralf,
Krause David S.
Publication year - 1998
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510270336
Subject(s) - medicine , hepatitis a vaccine , hepatitis a , hepatitis , immunogenicity , hepatitis b , viral hepatitis , vaccination , hepatitis b vaccine , immunology , chronic liver disease , vaccination schedule , liver disease , hepatitis c , fulminant hepatitis , virology , gastroenterology , hepatitis b virus , antibody , immunization , cirrhosis , virus , hbsag
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.