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

June 24, 2008
July 24, 2013
March 2008
October 2008   (final data collection date for primary outcome measure)
tetanus seroconversion rate [ Time Frame: 1 month and 6 month post vaccination ] [ Designated as safety issue: Yes ]
Td seroconversion rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00705692 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Renal Dialysis
  • Drug: Levamisole
  • Drug: Placebo
  • Experimental: Levamisole
    Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.
    Intervention: Drug: Levamisole
  • Placebo Comparator: Placebo
    Two placebo tablets daily, six days before and six days after Td vaccination.
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00705692
86_3893
Yes
Mohammad mahdi Sagheb, Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
Not Provided
Principal Investigator: Mohamad Mahdi Sagheb, MD Shiaz University of Medical Sciences
Shiraz University of Medical Sciences
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP