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.

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Background: A considerable number of people remain unprotected against hepatitis B. These people may require immunization at short notice before being exposed to situations or locations where a risk of infection is present. Currently, full active immunization against hepatitis B, when administered according to recommended schedules, takes 2-6 months. This open, randomized multicentric study evaluated the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in adults when it was administered according to three different rapid vaccination schedules. Methods: Five hundred and twenty four healthy adults (aged 18-59 years) were randomly divided into three groups. Hepatitis B vaccine was given intramuscularly in the deltoid muscle at months 0, 1, and 2 (group A); weeks 0, 14, and 28 (group B); and weeks 0, 7, and 21 (group C). Symptoms were recorded by the subjects on individual diary cards. AntiHBs were measured using radioimmunoassay (Ausab-Abbott); a seroprotective titer was defined as 10 IU/L. Results: At day 28, no significant difference in seroprotection rates (SPRs) i.e., seroconversion >= 10 IU/L,was observed, between groups B (55.6%) and C (65.2%), but both these groups had significantly greater SPRs than group A (15.0%). Although not significant (p=.07), groups B and C also had higher SPRs than group A (78.5% and 76.4% versus 65%) at day 56. One month after completing the three dose schedules, the SPRs were as follows: 89.0% (group A); 78.5% (group B); and 76.4% (group C), increasing to > 94% at month 7 to 8 in all three groups. The SPRs at month 13 were 95.8%, 98.9%, and 98.6%, respectively. Among the three groups, no significant differences were observed from month 2 onwards in either SPRs or geometric mean titers. In groups A, B, and C, 3.7%, 5.0%, and 7.1% of the vaccine injections were associated with local symptoms. Also 8.3%, 6.2%, and 6.3% of subjects exhibited general symptoms following each vaccine dose; all symptoms were transient and resolved spontaneously. Conclusions: This recombinant hepatitis B vaccine administered at weeks 0, 7, 21, or at weeks 0, 14, 28, rapidly elicits high rates of seroprotection, which persist at least until month 12.

We report on molecular characterization of hepatitis C virus (HCV) isolates in intravenous drug abusers, as compared to non-drug using patients with posttransfusion hepatitis or sporadic hepatitis of unknown origin. Virus typing was performed by RFLP analysis of PCR products in the 5' NCR. Subtyping was done by hybridization with subtype specific probes or by sequencing in the NS4 and NS5 region, respectively. HCV subtype 1b was found most commonly among all the isolates. However, the subtype 3a had a high prevalence (about 46%) in the group of drug addicts. In these subtype 3a isolates the N-terminal part of the E2 protein was highly variable. This confirms the presence of a hypervariable region (HVR1) in this envelope protein found in all hepatitis C viruses. Each subtype 3a isolate examined had a characteristic unique hypervariable region in the E2 protein. It is noteworthy that there are four amino acids in this region which were highly conserved between all HCV sequences published. It can be assumed that such conserved amino acids are significant for structure and function of this viral protein. In our HCV subtype 3a isolates the NS5 sequences were highly conserved.

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