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

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705692
• Other study ID #: 86_3893
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2008
• Last updated: July 24, 2013
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: July 2013
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

Drug:
• Levamisole

• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tetanus seroconversion rate		1 month and 6 month post vaccination	Yes