CLINICAL TRIAL
COMPARATIVE STUDY
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
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Immunogenicity of an accelerated vaccination regime with a combined hepatitis a/b vaccine in patients with chronic hepatitis C.

OBJECTIVES: Hepatitis A (HAV) and B (HBV) vaccinations are recommended in patients with chronic liver diseases.

METHODS: We prospectively investigated immunogenicity and safety of an accelerated vaccination protocol (0-7-21 days) with the combined hepatitis A/B vaccine (Twinrix(R)) versus the standard vaccination scheme (0-1-6 months) in hepatitis C virus-infected patients versus healthy volunteers.

RESULTS: Local and general symptoms were mostly mild in all groups. One month after completion of the accelerated vaccination or standard vaccination, with the combined hepatitis A/B vaccine anti-HAV seroconversion rates (>33 IU/l) were 89 % and 88 % in HCV-infected patients. Initial HCV-nonresponders developed protective anti-HAV antibodies in 94 % and 96 % after a booster dose. According to the anti-HBs seroprotection rate, HCV-infected patients developed protective anti-HBs titres (>10 IU/l) in 77 % and 82 % of cases one month after the accelerated and the standard vaccination scheme-at month 2 and 7, respectively. This anti-HBs seroprotection rate could even be increased to 84 % and 85 % when initial HCV-infected nonresponders where given a booster dose with the combined hepatitis A/B vaccine. Protective anti-HAV and anti-HBs titers were achieved as early as month 2 after the accelerated vaccination schedule in the majority of HCV-infected patients. Healthy subjects developed protective anti-HAV titers and anti-HBs titers in 100 % and 98 % after the accelerated and standard vaccination protocol.

CONCLUSIONS: This study is the first to have demonstrated that the accelerated combined hepatitis A/B vaccination is both safe and highly immunogenic against HAV and HBV in HCV-infected patients with well compensated liver disease.

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