OBJECTIVES: The association of anti-HBs immunoglobulins and anti-HBV vaccine could increase the immunogenicity of the latter. The aim of this prospective randomized trial was to compare the immunogenicity of anti-HBs vaccination and serovaccination in alcoholic patients with cirrhosis. METHODS:Alcoholic patients with cirrhosis were randomized in 2 groups: a) Vaccination group: 3 i.m. injections of GenHevac B followed by one booster at month 9; b) Serovaccination group: same vaccination schedule followed by one i.m. injection of anti-HBs immunoglobulins (500 IU). RESULTS:Twenty-five patients (17 males and 8 females, mean age 56 years) were included in the study: 13 received a vaccination and 12 received a serovaccination. After 12 months, the seroconversion rates were 69% and 67% in vaccination and in serovaccination groups, respectively. The predictive factors of non responsiveness were as following: Child B cirrhosis, low number of CD8, a high CD4/CD8 rate, the existence of HLA DR7 antigen, and the absence of HLA DR1 antigen. CONCLUSION: In alcoholic patients with cirrhosis, serovaccination does not increase the immunogenicity of anti-HBs vaccination and should not be recommended.
RCT Entities:
OBJECTIVES: The association of anti-HBs immunoglobulins and anti-HBV vaccine could increase the immunogenicity of the latter. The aim of this prospective randomized trial was to compare the immunogenicity of anti-HBs vaccination and serovaccination in alcoholicpatients with cirrhosis. METHODS:Alcoholicpatients with cirrhosis were randomized in 2 groups: a) Vaccination group: 3 i.m. injections of GenHevac B followed by one booster at month 9; b) Serovaccination group: same vaccination schedule followed by one i.m. injection of anti-HBs immunoglobulins (500 IU). RESULTS: Twenty-five patients (17 males and 8 females, mean age 56 years) were included in the study: 13 received a vaccination and 12 received a serovaccination. After 12 months, the seroconversion rates were 69% and 67% in vaccination and in serovaccination groups, respectively. The predictive factors of non responsiveness were as following: Child B cirrhosis, low number of CD8, a high CD4/CD8 rate, the existence of HLA DR7 antigen, and the absence of HLA DR1 antigen. CONCLUSION: In alcoholicpatients with cirrhosis, serovaccination does not increase the immunogenicity of anti-HBs vaccination and should not be recommended.