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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammad mahdi Sagheb, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00705692
First received: June 24, 2008
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Renal Dialysis
Drug: Levamisole
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • tetanus seroconversion rate [ Time Frame: 1 month and 6 month post vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00705692

Locations
Iran, Islamic Republic of
Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of, 1978 - 71345
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Principal Investigator: Mohamad Mahdi Sagheb, MD Shiaz University of Medical Sciences
  More Information

No publications provided by Shiraz University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mohammad mahdi Sagheb, Associate Professor of Medicine, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00705692     History of Changes
Other Study ID Numbers: 86_3893
Study First Received: June 24, 2008
Last Updated: July 24, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
Tetanus
Vaccines
Renal Dialysis
Levamisole

Additional relevant MeSH terms:
Tetanus
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Levamisole
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014