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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00705692

Enrollment

Registered

2008-06-26

Start date

2008-03-31

Completion date

2008-11-30

Last updated

2013-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

Tetanus, Vaccines, Renal Dialysis, Levamisole

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.

Interventions

DRUGLevamisole

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
tetanus seroconversion rate	1 month and 6 month post vaccination

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026