Text Size

A Study on Effect of Levamisole on Seroconversion Rate of Hemodialysis Patients to Td Vaccination

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00705692
First received: June 24, 2008
Last updated: June 25, 2008
Last verified: June 2008
History of Changes

June 24, 2008
June 25, 2008
March 2008
May 2008   (final data collection date for primary outcome measure)
Td seroconversion rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00705692 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study on Effect of Levamisole on Seroconversion Rate of Hemodialysis Patients to Td Vaccination
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

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 .

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Kidney Disease
  • Drug: Levamisole
    100 mg/day po,2 tab 50 mg stat in morning QD 6 days before and after receiving Td vaccine
    Other Names:
    • levamisole,Mfg. by Rooz Daru,Tehran,Iran ,Batch NO.F-1
    • Mfg.Date 4-2006.Exp Date 4-2008
  • Biological: Tetanus diphtheria vaccine
    IM injection 0.5 CC stat of Td vaccine,
    Other Names:
    • Td vaccine,
    • Serum institute of India LCD.SII,HADAPSAR_PUNE411028 india
    • Serial N:40701-B
  • Drug: Placebo
    Placebo 2 tab po every morning QD
    Other Name: Placebo is made of starch with same shape and color as Levamisole tablets by Dr.Hesam Pharmacy
  • Active Comparator: A
    randomized hemodialysis patients, unprotected to diphteria and tetanous who received tetanus diphteria vaccine plus Levamisole tablets
    Interventions:
    • Drug: Levamisole
    • Biological: Tetanus diphtheria vaccine
  • Placebo Comparator: B
    randomized hemodialysis patients, unprotected to diphteria and tetanous who received tetanus diphtheria vaccine plus placebo tablets
    Interventions:
    • Biological: Tetanus diphtheria vaccine
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00705692
86_3893
Yes
Vice chanceler for research of Shiraz Medical Science University, Shiraz Uronephrology Research Center
Shiraz University of Medical Sciences
Not Provided
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
Shiraz University of Medical Sciences
June 2008

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