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

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00705692

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Drug: Levamisole Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levamisole Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.	Drug: Levamisole
Placebo Comparator: Placebo Two placebo tablets daily, six days before and six days after Td vaccination.	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Levamisole

Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.

Drug: Levamisole

Placebo Comparator: Placebo

Two placebo tablets daily, six days before and six days after Td vaccination.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

tetanus seroconversion rate [1 month and 6 month post vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.