Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 24, 2008
CompletedFirst Posted
Study publicly available on registry
June 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJuly 26, 2013
July 1, 2013
7 months
June 24, 2008
July 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tetanus seroconversion rate
1 month and 6 month post vaccination
Study Arms (2)
Levamisole
EXPERIMENTALTwo 50 mg levamisole tablets daily, six days before and six days after Td vaccination.
Placebo
PLACEBO COMPARATORTwo placebo tablets daily, six days before and six days after Td vaccination.
Interventions
Eligibility Criteria
You may qualify if:
- being under regular hemodialysis for more than 3 months
- unprotective baseline levels of antitetanus IgG
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences
Shiraz, Fars, 1978 - 71345, Iran
Related Publications (1)
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.
PMID: 24341659DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamad Mahdi Sagheb, MD
Shiaz University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
June 24, 2008
First Posted
June 26, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
July 26, 2013
Record last verified: 2013-07