title: Effects of Oral Levamisole as an Adjuvant to Hepatitis B Vaccine in HIV/ AIDS Patients: A Randomized Controlled Trial.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Liver Disease and Hepatitis Research Center, Kermanshah University of Medical Sciences, Kermanshah, IR Iran.
authors.forename: Babak
authors.initials: B
authors.lastname: Sayad
authors.forename: Seyyed Moayed
authors.initials: SM
authors.lastname: Alavian
authors.forename: Farid
authors.initials: F
authors.lastname: Najafi
authors.forename: Bita
authors.initials: B
authors.lastname: Soltani
authors.forename: Maria
authors.initials: M
authors.lastname: Shirvani
authors.forename: Alireza
authors.initials: A
authors.lastname: Janbakhsh
authors.forename: Feyzollah
authors.initials: F
authors.lastname: Mansouri
authors.forename: Mandana
authors.initials: M
authors.lastname: Afsharian
authors.forename: Siavash
authors.initials: S
authors.lastname: Vaziri
authors.forename: Arash
authors.initials: A
authors.lastname: Alikhani
authors.forename: Homayoon
authors.initials: H
authors.lastname: Bashiri
keywords: HIV; Hepatitis B Virus; Levamisole; Vaccination