Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-21 @ 5:39 PM
Study NCT ID:
NCT03729102
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Tolerance After Frequent Rabies Booster Vaccinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011818', 'term': 'Rabies'}], 'ancestors': [{'id': 'D018353', 'term': 'Rhabdoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The serum samples from all participants would be labelled as the codes, of which the laboratory technicians could not access to the groups or other details of the participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There would be two study groups. Those who had received primary immunization would be the control group. While persons who had received primary immunization and later received booster vaccination for at least 3 times would be the study group.\n\nAll participants would be given one dose of rabies vaccine and monitored the immunological cells and cytokines before and after the rabies booster injection.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2018-11-01', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cytokines', 'timeFrame': 'Change from baseline of quantitative measurement of cytokines levels would be measured before (baseline) and one month after receipt of rabies booster vaccination and compared between 2 arms', 'description': 'Cytokines i.e., IL-10, TGF-Beta are measured by ELISA'}], 'primaryOutcomes': [{'measure': 'Rabies specific regulatory T cells', 'timeFrame': 'Change from baseline of numbers of Rabies specific regulatory T cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms', 'description': 'Rabies specific regulatory T cells are measured by flow cytometry method'}, {'measure': 'Rabies specific regulatory B cells', 'timeFrame': 'Change from baseline of numbers of Rabies specific regulatory B cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms', 'description': 'Rabies specific regulatory B cells are measured by flow cytometry method'}, {'measure': 'Rabies specific T follicular helper cells', 'timeFrame': 'Change from baseline of numbers of Rabies specific T follicular helper cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms', 'description': 'Rabies specific T follicular helper cells are measured by flow cytometry method'}], 'secondaryOutcomes': [{'measure': 'Rabies Neutralizing Antibody Titers (RNab)', 'timeFrame': 'before (baseline) and one month after receipt of rabies booster vaccination', 'description': 'Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rabies vaccination'], 'conditions': ['Rabies']}, 'descriptionModule': {'briefSummary': 'To study immunological tolerance effect after frequent rabies booster vaccination', 'detailedDescription': 'Previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. We study immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Previously received rabies vaccination\n\nExclusion Criteria:\n\n* Had immunocompromised conditions\n* Received blood or blood product within 3 months\n* Received anti-malarial drugs'}, 'identificationModule': {'nctId': 'NCT03729102', 'briefTitle': 'Immunological Tolerance After Frequent Rabies Booster Vaccinations', 'organization': {'class': 'OTHER', 'fullName': 'Queen Saovabha Memorial Institute'}, 'officialTitle': 'Immunological Tolerance After Frequent Rabies Booster Vaccinations', 'orgStudyIdInfo': {'id': 'QSMI-IRB 2/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Persons who had received primary immunization', 'interventionNames': ['Biological: Blood drawn after rabies vaccine booster vaccination']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Persons who had received primary immunization and later received booster vaccination for at least 3 times', 'interventionNames': ['Biological: Blood drawn after rabies vaccine booster vaccination']}], 'interventions': [{'name': 'Blood drawn after rabies vaccine booster vaccination', 'type': 'BIOLOGICAL', 'description': 'All participants would be given one dose of rabies vaccine and monitor the immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cells, cytokines i.e., IL-10, TGF-Beta, and Rabies neutralizing antibody titers, before and after the booster injection', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suda Punrin, MD', 'role': 'CONTACT', 'email': 'sudapunrin@gmail.com', 'phone': '+66 2 2520161', 'phoneExt': '125'}, {'name': 'Terapong Tantawichien, MD', 'role': 'CONTACT', 'email': 'terapong_tantawichien@hotmail.com', 'phone': '+66 2 2520161', 'phoneExt': '132'}], 'facility': 'Queen Saovabha Memorial Institute', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'centralContacts': [{'name': 'Suda Sibunruang, MD', 'role': 'CONTACT', 'email': 'sudapunrin@gmail.com', 'phone': '+66 2 2520161', 'phoneExt': '125'}, {'name': 'Terapong Tantawichien, MD', 'role': 'CONTACT', 'email': 'terapong_tantawichien@hotmail.com', 'phone': '+66 2 2520161', 'phoneExt': '125'}], 'overallOfficials': [{'name': 'Suda Sibunruang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Saovabha Memorial Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Saovabha Memorial Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suda Sibunruang', 'investigatorAffiliation': 'Queen Saovabha Memorial Institute'}}}}