A Study on Effect of Levamisole on Seroconversion Rate of Hemodialysis Patients to Td Vaccination - Full Text View

Sponsored by:	Shiraz University of Medical Sciences
Information provided by:	Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00705692

Purpose

to determine seroconversion of hemodialysis(HD) patients due to chronic renal failure ,after receiving Td booster vaccine and evaluate the effect of Levamisole(LMS) on antitetanus and antidiphtheria levels after receiving Td booster vaccine .

Condition	Intervention	Phase
Kidney Disease	Drug: Levamisole Biological: Tetanus diphtheria vaccine Drug: Placebo	Phase II Phase III

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Levamisole Levamisole hydrochloride Diphtheria-Tetanus Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study on the Antitetanus and Antidiphtheria Antibody Titer in the Hemodialysis Patients and Comparison of Their Response to Td Booster Vaccine and Placebo With Td Booster Vaccine and Levamisole .Shiraz -1386

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

Primary Outcome Measures:

Td seroconversion rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment:	33
Study Start Date:	March 2008
Study Completion Date:	June 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator randomized hemodialysis patients, unprotected to diphteria and tetanous who received tetanus diphteria vaccine plus Levamisole tablets	Drug: Levamisole 100 mg/day po,2 tab 50 mg stat in morning QD 6 days before and after receiving Td vaccine Biological: Tetanus diphtheria vaccine IM injection 0.5 CC stat of Td vaccine,
B: Placebo Comparator randomized hemodialysis patients, unprotected to diphteria and tetanous who received tetanus diphtheria vaccine plus placebo tablets	Biological: Tetanus diphtheria vaccine IM injection 0.5 CC stat of Td vaccine, Drug: Placebo Placebo 2 tab po every morning QD

Detailed Description:

First antitetanus and antidiphtheria levels of hemodialysis patients were evaluated be ELISA method.

then unprotected patients to both Tetanus and Diphtheria who did not have risk factors to develop Levamisoles side effects,were selected.

then the patients were randomized to 2 groups after approval of patients to participate in this double blind research.

then all the patients received Td booster vaccine,first group received Levamisole 100mg/day 6 days before and after receiving vaccine and placebo 2 tab/day. then serum samples obtained from patients 1 month after receiving Td vaccine to determine level of antitetanus and antidiphtheria antibody by ELISA method.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of chronic Renal Disease
Must be able to swallow tablets
currently under hemodialysis
unprotected levels of antitetanus and antidiphtheria IgG levels at start of trail before receiving Td vaccine

Exclusion Criteria:

Leukopenia at start and during experiment
receiving Cytotoxic drugs
Hospitalized in last 3 months
receiving Td vaccine in the last year prior to trial

Contacts and Locations

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

Locations

Iran, Islamic Republic of, Fars
Shiraz Medical Science University, Faghihi Hospital Hemodialysis Center
Shiraz, Fars, Iran, Islamic Republic of, 1978 - 71345

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

Principal Investigator:	Sharareh Sajjadi, Med.Intern	Shiaz University of Medical Science
Study Director:	Mohamad Mehdi Sagheb, Nephrologist	Shiaz University of Medical Science
Principal Investigator:	Golmehr Sajjady, GP	Dundee University of Medical Science

More Information

Additional Information:

Shiraz University of Medical Sciences official site This link exits the ClinicalTrials.gov site

Publications:

Sagheb MM, Sajjadi S, Sajjadi G. Antitetanus toxoid antibody titer of chronic hemodialysis patients in iran. Iran J Immunol. 2008 Mar;5(1):45-50.

Responsible Party:	Shiraz Uronephrology Research Center ( Vice chanceler for research of Shiraz Medical Science University )
Study ID Numbers:	86_3893
Study First Received:	June 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705692 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:

antitetanous IgG level
antidiphtheria IgG level
hemodialysis patients
Levamisole
Td booster vaccine

LMS effect
seroconversion rate
HD cases
HD patients

Study placed in the following topic categories:

Antibodies
Immunologic Factors
Urologic Diseases
Adjuvants, Immunologic
Anthelmintics

Levamisole
Kidney Diseases
Antirheumatic Agents
Immunoglobulins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Anthelmintics
Pharmacologic Actions
Antiparasitic Agents

Urologic Diseases
Therapeutic Uses
Kidney Diseases
Levamisole
Antirheumatic Agents
Antinematodal Agents

ClinicalTrials.gov processed this record on May 06, 2009