As. Rosman et al., EFFICACY OF A HIGH AND ACCELERATED DOSE OF HEPATITIS-B VACCINE IN ALCOHOLIC PATIENTS - A RANDOMIZED CLINICAL-TRIAL, The American journal of medicine, 103(3), 1997, pp. 217-222
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.