The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical Trial

Despite its proven efficacy, the hepatitis B vaccine requires improvements in immune enhancement and durability, especially in the elderly. Levamisole, an immune modulator, has been tested as an adjuvant to hepatitis B vaccine in several studies in immune-compromised populations. However, we aimed t...

Full description

Bibliographic Details
Main Authors: Mousalreza Hosseini, Payman Shalchiantabrizi, Maliheh Dadgarmoghaddam, Saeideh Ahmady-Simab, Azizollah Behjati, Masoumeh Salari
Format: Article
Language:English
Published: Tehran University of Medical Sciences 2017-06-01
Series:Iranian Journal of Allergy, Asthma and Immunology
Subjects:
Online Access:https://ijaai.tums.ac.ir/index.php/ijaai/article/view/873
_version_ 1818267027560726528
author Mousalreza Hosseini
Payman Shalchiantabrizi
Maliheh Dadgarmoghaddam
Saeideh Ahmady-Simab
Azizollah Behjati
Masoumeh Salari
author_facet Mousalreza Hosseini
Payman Shalchiantabrizi
Maliheh Dadgarmoghaddam
Saeideh Ahmady-Simab
Azizollah Behjati
Masoumeh Salari
author_sort Mousalreza Hosseini
collection DOAJ
description Despite its proven efficacy, the hepatitis B vaccine requires improvements in immune enhancement and durability, especially in the elderly. Levamisole, an immune modulator, has been tested as an adjuvant to hepatitis B vaccine in several studies in immune-compromised populations. However, we aimed to evaluate the effect of levamisole on the immune response to hepatitis B vaccine in healthy subjects. In this randomized clinical trial, healthy family members of chronic hepatitis B patients were given twenty-microgram intramuscular injections of hepatitis B vaccine at 0, 1, and 6 months and 50 miligrams of oral  levamisole twice a day for two weeks with every vaccination dose. Serum hepatitis B surface antibody (HBsAb) levels of ultimately 98 individuals were measured one month after the final vaccination dose and compared to those of 119 subjects that received placebo and vaccine with an identical regimen. HBsAb levels >10 mIU/mL were considered protective. The Student’s t-test, Mann-Whitney test, Kruskal–Wallis analysis (quantitative comparison in age groups), Chi-square test, and the Pearson correlation were used to analyze data. p<0.05 was considered significant. Serum HBsAb levels were significantly higher in the test group (p<0.001). All test subjects had levels above 50 mIU/mL (86.7% exceeding 100 mIU/mL). The quantitative response according to age groups was remarkable (p=0.01 and p<0.001 for placebo and levamisole, respectively), while that of gender was insignificant (p=0.9). Unlike HBsAb titers amongst controls, levels in the levamisole group were affected by smoking (p=0.79 and p=0.006, respectively). We conclude that oral levamisole as an adjuvant to the hepatitis B vaccine enhances the anti-HBs antibody in healthy vaccinees.
first_indexed 2024-12-12T20:16:04Z
format Article
id doaj.art-56eb86a4203945faa0d64dcbb4c4be26
institution Directory Open Access Journal
issn 1735-1502
1735-5249
language English
last_indexed 2024-12-12T20:16:04Z
publishDate 2017-06-01
publisher Tehran University of Medical Sciences
record_format Article
series Iranian Journal of Allergy, Asthma and Immunology
spelling doaj.art-56eb86a4203945faa0d64dcbb4c4be262022-12-22T00:13:22ZengTehran University of Medical SciencesIranian Journal of Allergy, Asthma and Immunology1735-15021735-52492017-06-01163873The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical TrialMousalreza Hosseini0Payman Shalchiantabrizi1Maliheh Dadgarmoghaddam2Saeideh Ahmady-Simab3Azizollah Behjati4Masoumeh Salari5Department of Gasteroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Internal Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Community Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IranThe Vice Chancellor of Research, Mashhad University of Medical Sciences, Mashhad, IranImmonology Research Center, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Internal Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IranDespite its proven efficacy, the hepatitis B vaccine requires improvements in immune enhancement and durability, especially in the elderly. Levamisole, an immune modulator, has been tested as an adjuvant to hepatitis B vaccine in several studies in immune-compromised populations. However, we aimed to evaluate the effect of levamisole on the immune response to hepatitis B vaccine in healthy subjects. In this randomized clinical trial, healthy family members of chronic hepatitis B patients were given twenty-microgram intramuscular injections of hepatitis B vaccine at 0, 1, and 6 months and 50 miligrams of oral  levamisole twice a day for two weeks with every vaccination dose. Serum hepatitis B surface antibody (HBsAb) levels of ultimately 98 individuals were measured one month after the final vaccination dose and compared to those of 119 subjects that received placebo and vaccine with an identical regimen. HBsAb levels >10 mIU/mL were considered protective. The Student’s t-test, Mann-Whitney test, Kruskal–Wallis analysis (quantitative comparison in age groups), Chi-square test, and the Pearson correlation were used to analyze data. p<0.05 was considered significant. Serum HBsAb levels were significantly higher in the test group (p<0.001). All test subjects had levels above 50 mIU/mL (86.7% exceeding 100 mIU/mL). The quantitative response according to age groups was remarkable (p=0.01 and p<0.001 for placebo and levamisole, respectively), while that of gender was insignificant (p=0.9). Unlike HBsAb titers amongst controls, levels in the levamisole group were affected by smoking (p=0.79 and p=0.006, respectively). We conclude that oral levamisole as an adjuvant to the hepatitis B vaccine enhances the anti-HBs antibody in healthy vaccinees.https://ijaai.tums.ac.ir/index.php/ijaai/article/view/873ImmunizationHepatitis B vaccinesLevamisole
spellingShingle Mousalreza Hosseini
Payman Shalchiantabrizi
Maliheh Dadgarmoghaddam
Saeideh Ahmady-Simab
Azizollah Behjati
Masoumeh Salari
The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical Trial
Iranian Journal of Allergy, Asthma and Immunology
Immunization
Hepatitis B vaccines
Levamisole
title The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical Trial
title_full The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical Trial
title_fullStr The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical Trial
title_full_unstemmed The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical Trial
title_short The Effect of Oral Levamisole Co-administration on the Level of Immune Response to Hepatitis B Vaccine in Healthy Individuals: A Randomized Clinical Trial
title_sort effect of oral levamisole co administration on the level of immune response to hepatitis b vaccine in healthy individuals a randomized clinical trial
topic Immunization
Hepatitis B vaccines
Levamisole
url https://ijaai.tums.ac.ir/index.php/ijaai/article/view/873
work_keys_str_mv AT mousalrezahosseini theeffectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT paymanshalchiantabrizi theeffectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT malihehdadgarmoghaddam theeffectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT saeidehahmadysimab theeffectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT azizollahbehjati theeffectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT masoumehsalari theeffectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT mousalrezahosseini effectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT paymanshalchiantabrizi effectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT malihehdadgarmoghaddam effectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT saeidehahmadysimab effectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT azizollahbehjati effectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial
AT masoumehsalari effectoforallevamisolecoadministrationonthelevelofimmuneresponsetohepatitisbvaccineinhealthyindividualsarandomizedclinicaltrial