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

authors:

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

Liver Disease and Hepatitis Research Center, Kermanshah University of Medical Sciences, babaksayad@yahoo.com, IR Iran
Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, IR Iran
Health Research Center, Kermanshah University of Medical Sciences, IR Iran
Hepatitis Monthly: Vol.12, issue 9; 6234
published online: September 30, 2012
article type: Research Article
received: May 9, 2012
accepted: June 13, 2012
DOI: https://doi.org/10.5812/hepatmon.6234

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. 2012;12(9):6234. https://doi.org/10.5812/hepatmon.6234.

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.

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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