- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00705692
Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients
July 24, 2013 updated by: Mohammad mahdi Sagheb, Shiraz University of Medical Sciences
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of, 1978 - 71345
- Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Levamisole
Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.
|
|
PLACEBO_COMPARATOR: Placebo
Two placebo tablets daily, six days before and six days after Td vaccination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tetanus seroconversion rate
Time Frame: 1 month and 6 month post vaccination
|
1 month and 6 month post vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mohamad Mahdi Sagheb, MD, Shiaz University of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ACTUAL)
October 1, 2008
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
June 24, 2008
First Submitted That Met QC Criteria
June 25, 2008
First Posted (ESTIMATE)
June 26, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 26, 2013
Last Update Submitted That Met QC Criteria
July 24, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Clostridium Infections
- Tetanus
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antirheumatic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Levamisole
Other Study ID Numbers
- 86_3893
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Dialysis
-
Trakya UniversityCompleted
-
University of PittsburghNational Institute of Nursing Research (NINR); University of IowaCompleted
-
Inje UniversityKorea University Guro Hospital; Seoul National University; Hallym University... and other collaboratorsCompleted
-
Universidad Miguel Hernandez de ElcheCompleted
-
National University Hospital, SingaporeNational University of SingaporeUnknown
-
Far Eastern Memorial HospitalUnknown
-
Hamamatsu UniversityMaruyama Memorial General Hospital; Seirei Hamamatsu General Hospital; Iwata... and other collaboratorsTerminated
-
Hamamatsu UniversityMaruyama Memorial General Hospital; Seirei Hamamatsu General Hospital; Iwata... and other collaboratorsCompleted
-
The First Affiliated Hospital of Zhejiang Chinese...Not yet recruiting
-
Rabin Medical CenterNot yet recruitingRenal Dialysis
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States