Effects of Oral Levamisole as an Adjuvant to Hepatitis B Vaccine in HIV/ AIDS Patients: A Randomized Controlled Trial

Background: human immunodeficiency virus (hiv) infected patients are also frequently exposed to the hepatitis b virus (hbv), due to the common routes of transmission, therefore, prevention of hepatitis b results in decreased complications of the disease. objectives: since the immune response of hiv patients to hepatitis b vaccination is less robust than that found in healthy individuals, this study aimed to evaluate the effect of a levamisole adjuvant on increasing the immune response. patients and methods: in this study, 89 hiv infected patients, without a history of hbv infection or vaccination, were randomly allocated into experimental (44 patients) and control (45 patients) groups. hbv vaccination was performed using the hepavax-gene tf vaccine, 40 μg three times at intervals of; zero, one, and three months. levamisole 50 mg twice a day or a placebo, was administered to the experimental and control groups, respectively, for a period of six days before to six days after the vaccination. immune response was evaluated by measuring hepatitis b surface antibodies (hbsab) concurrently with the second and third vaccine administration, and at one and three months at the conclusion of the vaccination program. results: the immune response following the threevaccinations was higher in those who were receiving levamisole compared with the controls (90% vs. 65.38%) (p = 0.05). furthermore, the immune response and the mean antibody titer following the repeated vaccination in the experimental group showed a higher increase than in the control group. the immune response and the mean titer of antibody were not associated with; age, sex, body mass index, history of smoking and/or intravenous drug use in either of the groups. however, regarding cd4+ cells more than 200 cell/mm3, mean antibody production significantly increased in both groups. conclusions: using levamisole with the hepatitis b vaccination can increase the immune response and antibody titer mean in hiv infected patients. since these patients have a more complete response with cd4+ cells more than 200 cell/mm3, vaccination and effective adjuvants seem to be most beneficial when cd4+ cells are greater than 200 cell/mm3, in hiv infected patients.