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

Primary Purpose

Renal Dialysis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Levamisole
Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Dialysis focused on measuring Tetanus, Vaccines, Renal Dialysis, Levamisole

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levamisole

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

tetanus seroconversion rate

Secondary Outcome Measures

Full Information

First Posted
June 24, 2008
Last Updated
July 24, 2013
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00705692
Brief Title
Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients
Official Title
Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Dialysis
Keywords
Tetanus, Vaccines, Renal Dialysis, Levamisole

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levamisole
Arm Type
Experimental
Arm Description
Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two placebo tablets daily, six days before and six days after Td vaccination.
Intervention Type
Drug
Intervention Name(s)
Levamisole
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
tetanus seroconversion rate
Time Frame
1 month and 6 month post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Mahdi Sagheb, MD
Organizational Affiliation
Shiaz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
1978 - 71345
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24341659
Citation
Fallahzadeh MK, Sajjadi S, Singh N, Khajeh M, Sagheb MM. Effect of levamisole supplementation on tetanus vaccination response rates in haemodialysis patients: a randomized double-blind placebo-controlled trial. Nephrology (Carlton). 2014 Jan;19(1):27-31. doi: 10.1111/nep.12158.
Results Reference
derived

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

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