Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients
Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to Hepatitis B virus (HBV) vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response rate in hemodialysis patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Trial|
- tetanus seroconversion rate [ Time Frame: 1 month and 6 month post vaccination ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.
Placebo Comparator: Placebo
Two placebo tablets daily, six days before and six days after Td vaccination.
Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to HBV vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on Td vaccine response rate in hemodialysis patients. In this randomized double-blind placebo-controlled trial 40 hemodialysis patients who had not received tetanus vaccination in a year before investigation and had unprotective anti-tetanus immunoglobulin G (IgG) levels (<0.1 International Unit [IU]/ml) were enrolled. These patients were randomized into two equal groups to receive one dose of intramuscular Td vaccine supplemented with either levamisole 100 mg or placebo daily, six days before and six days after vaccination. The anti-tetanus IgG levels were measured 1 and 6 months after vaccination.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705692
|Iran, Islamic Republic of|
|Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences|
|Shiraz, Fars, Iran, Islamic Republic of, 1978 - 71345|
|Principal Investigator:||Mohamad Mahdi Sagheb, MD||Shiaz University of Medical Sciences|