SAFETY AND IMMUNOGENICITY OF HEPATITIS-A VACCINE IN PATIENTS WITH CHRONIC LIVER-DISEASE

Acute hepatitis A superimposed on chronic liver disease (CLD) has been associated with severe or fulminant hepatitis, An open, multicenter s tudy was performed to compare the safety and immunogenicity of an inac tivated hepatitis A vaccine in patients with CLD with that in healthy subjects. A secondary objective was to compare the safety of the hepat itis A vaccine with that of a commercial hepatitis B vaccine in subjec ts with chronic hepatitis C. A total of 475 subjects over the age of 1 8 years were enrolled into 1 of 5 groups according to history, serolog ical data, and previous diagnosis, Patients in groups 1 (healthy adult s), 2 (chronic hepatitis B), 3 (chronic hepatitis C), and 5 (other CLD not caused by viral hepatitis) were vaccinated with two doses of inac tivated hepatitis A vaccine, 6 months apart, Patients in group 4 (chro nic hepatitis C) received 3 doses of a recombinant hepatitis B vaccine , according to a 0-, 1-, and 6-month schedule, Local injection-site sy mptoms were the most common reactions reported following vaccination i n all groups (35.5% of all doses), with the hepatitis B vaccine elicit ing 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 th an did subjects with chronic hepatitis C (73.7%) or CLD of nonviral et iologies (83.1%), more than 94% of all vaccinees were seropositive for anti-HAN 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 c onclusion, hepatitis A vaccine was well tolerated and induced a satisf actory immune response in patients with chronic hepatitis B, chronic h epatitis C, and miscellaneous CLD.