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

Author(s):
Babak SayadBabak SayadBabak Sayad ORCID1,*, Seyyed Moayed AlavianSeyyed Moayed Alavian2, Farid NajafiFarid Najafi3, Bita SoltaniBita SoltaniBita Soltani ORCID1, Maria ShirvaniMaria ShirvaniMaria Shirvani ORCID1, Alireza JanbakhshAlireza JanbakhshAlireza Janbakhsh ORCID1, Feyzollah MansouriFeyzollah MansouriFeyzollah Mansouri ORCID1, Mandana AfsharianMandana AfsharianMandana Afsharian ORCID1, Siavash VaziriSiavash VaziriSiavash Vaziri ORCID1, Arash AlikhaniArash AlikhaniArash Alikhani ORCID1, Homayoon BashiriHomayoon BashiriHomayoon Bashiri ORCID1
1Liver Disease and Hepatitis Research Center, Kermanshah University of Medical Sciences, [email protected], IR Iran
2Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, IR Iran
3Health Research Center, Kermanshah University of Medical Sciences, IR Iran

Hepatitis Monthly:Vol. 12, issue 9; 6234
Published online:Sep 30, 2012
Article type:Research Article
Received:May 09, 2012
Accepted:Jun 13, 2012
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. doi: 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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