Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-05 @ 8:07 AM
Study NCT ID:
NCT00705692
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2008-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007978', 'term': 'Levamisole'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2008-06-24', 'studyFirstSubmitQcDate': '2008-06-25', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tetanus seroconversion rate', 'timeFrame': '1 month and 6 month post vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tetanus', 'Vaccines', 'Renal Dialysis', 'Levamisole'], 'conditions': ['Renal Dialysis']}, 'referencesModule': {'references': [{'pmid': '24341659', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being under regular hemodialysis for more than 3 months\n* unprotective baseline levels of antitetanus IgG\n\nExclusion Criteria:\n\n* tetanus diphtheria (Td) vaccination in past year\n* leukopenia (WBC\\<1500 cells/mcL)\n* immunosuppressive drug exposure in past 2 months\n* recent hospitalization or history of transfusion of blood products in the past 3 months.'}, 'identificationModule': {'nctId': 'NCT00705692', 'briefTitle': 'Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '86_3893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levamisole', 'description': 'Two 50 mg levamisole tablets daily, six days before and six days after Td vaccination.', 'interventionNames': ['Drug: Levamisole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Two placebo tablets daily, six days before and six days after Td vaccination.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levamisole', 'type': 'DRUG', 'armGroupLabels': ['Levamisole']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1978 - 71345', 'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Mohamad Mahdi Sagheb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiaz University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Mohammad mahdi Sagheb', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}