Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients

Phase 2

Completed

• Conditions: Renal Dialysis
• Interventions: Drug: Levamisole; Drug: Placebo

• Registration Number: NCT00705692
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• being under regular hemodialysis for more than 3 months
• unprotective baseline levels of antitetanus IgG

Exclusion Criteria

• tetanus diphtheria (Td) vaccination in past year
• leukopenia (WBC<1500 cells/mcL)
• immunosuppressive drug exposure in past 2 months
• recent hospitalization or history of transfusion of blood products in the past 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levamisole	Levamisole	Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.
Placebo	Placebo	Two placebo tablets daily, six days before and six days after Td vaccination.

Primary Outcome Measures

Name	Time	Method
tetanus seroconversion rate	1 month and 6 month post vaccination

Trial Locations

Locations (1)

Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of