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 a lcoholic patients. PATIENTS AND METHODS: One hundred ten alcoholic pat ients were randomized to either receive the standard dose (20 mu g at 0, 1, and 6 months) or a high dose (40 mu g at 0, 1, 2, and 6 months) of recombinant hepatitis B vaccine (Engerix-B(R)). Patients were monit ored for relapse of drinking using self-report, serial serum carbohydr ate deficient transferrin, and collateral verification. The final tite r of antibody to hepatitis B surface antigen (anti-HBs) was obtained 1 2 months after the first vaccine dose; a seroconversion was defined as a titer greater than 10 mlU/ml. RESULTS: One hundred subjects complet ed the study; 10 of these had clinical or pathological evidence of cir rhosis. Thirty-six out of 48 (75%) of patients administered the high-d ose 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 versu s 39.4 mlU/ml, P <0.01). Logistic regression demonstrated a significan t effect on seroconversion for the vaccine dose (P <0.005) and serum a lbumin (P = 0.05) but not for the other variables such as race, age, d rinking during the study, serum creatinine, arm muscle circumference, and cirrhosis. CONCLUSIONS: A high- and accelerated-dose regimen of he patitis B improves the serological response in alcoholic patients. Thi s regimen (currently recommended for hemodialysis patients) should now also be considered for patients with a history of alcoholism. (C) 199 7 by Excerpta Medica, Inc.