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


Babak Sayad ORCID 1 , * , Seyyed Moayed Alavian 2 , Farid Najafi 3 , Bita Soltani ORCID 1 , Maria Shirvani ORCID 1 , Alireza Janbakhsh ORCID 1 , Feyzollah Mansouri ORCID 1 , Mandana Afsharian ORCID 1 , Siavash Vaziri ORCID 1 , Arash Alikhani ORCID 1 , Homayoon Bashiri ORCID 1

1 Liver Disease and Hepatitis Research Center, Kermanshah University of Medical Sciences, [email protected], IR Iran

2 Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, IR Iran

3 Health Research Center, Kermanshah University of Medical Sciences, IR Iran

How to Cite: Sayad B, Moayed Alavian S, Najafi F, Soltani B, Shirvani M, et al. Effects of Oral Levamisole as an Adjuvant to Hepatitis B Vaccine in HIV/ AIDS Patients: A Randomized Controlled Trial, Hepat Mon. Online ahead of Print ; 12(9):6234. doi: 10.5812/hepatmon.6234.


Hepatitis Monthly: 12 (9); 6234
Published Online: September 30, 2012
Article Type: Research Article
Received: May 9, 2012
Accepted: June 13, 2012


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 ?g 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.

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