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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Trial

Conditions
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Renal Dialysis

Intervention / Treatment
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* Drug: Levamisole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levamisole<br>Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination. | Drug: Levamisole<br> <br> |
| Placebo Comparator: Placebo<br>Two placebo tablets daily, six days before and six days after Td vaccination. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tetanus seroconversion rate |  | 1 month and 6 month post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tetanus, Vaccines, Renal Dialysis, Levamisole