Efficacy of a High and Accelerated Dose of Hepatitis B Vaccine in Alcoholic Patients: A Randomized Clinical Trial

PURPOSE: A randomized, double-blind trial was conducted to compare the efficacy of a high-dose versus standard-dose hepatitis B vaccine in alcoholic patients. PATIENTS AND METHODS: One hundred ten alcoholic patients were randomized to either receive the standard dose (20 μg at 0, 1, and 6 months) or a high dose (40 μg at 0, 1, 2, and 6 months) of recombinant hepatitis B vaccine (Engerix-B®). Patients were monitored for relapse of drinking using self-report, serial serum carbohydrate deficient transferrin, and collateral verification. The final titer of antibody to hepatitis B surface antigen (anti-HBs) was obtained 12 months after the first vaccine dose; a seroconversion was defined as a titer greater than 10 mIU/ml. RESULTS: One hundred subjects completed the study; 10 of these had clinical or pathological evidence of cirrhosis. Thirty-six out of 48 (75%) of patients administered the high-dose regimen seroconverted compared with 24 of 52 (46%) in the standard dose group (P<0.005). The mean anti-HBs titer of the high dose group was significantly greater than of the standard dose group (76.4 versus 39.4 mIU/ml, P<0.01). Logistic regression demonstrated a significant effect on seroconversion for the vaccine dose (P<0.005) and serum albumin ( ) but not for the other variables such as race, age, drinking during the study, serum creatinine, arm muscle circumference, and cirrhosis. CONCLUSIONS: A high- and accelerated-dose regimen of hepatitis B improves the serological response in alcoholic patients. This regimen (currently recommended for hemodialysis patients) should now also be considered for patients with a history of alcoholism.