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

Shiraz University of Medical Sciences

Status and phase

Completed

Phase 2

Conditions

Renal Dialysis

Treatments

Drug: Levamisole

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00705692

86_3893

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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.