Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-06-09 @ 10:05 AM
Study NCT ID:
NCT03228069
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2017-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rabies specific regulatory T cells', 'timeFrame': 'Numbers of Rabies specific regulatory T cells after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.', 'description': 'Rabies specific regulatory T cells is measured by flow cytometry method'}], 'primaryOutcomes': [{'measure': 'Rabies Neutralizing Antibody Titers (RNab)', 'timeFrame': 'GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.', 'description': 'Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)'}], 'secondaryOutcomes': [{'measure': 'Rabies specific T cell response', 'timeFrame': 'Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.', 'description': 'Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rabies vaccination'], 'conditions': ['Rabies']}, 'descriptionModule': {'briefSummary': 'To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before', 'detailedDescription': 'Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy HIV-infected adults\n* Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.\n\nExclusion Criteria:\n\n* Have any active opportunistic infections\n* Received blood or blood product within 3 months\n* Received anti-malarial drugs\n* Received rabies vaccination in a previous year.'}, 'identificationModule': {'nctId': 'NCT03228069', 'briefTitle': 'Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults', 'organization': {'class': 'OTHER', 'fullName': 'Queen Saovabha Memorial Institute'}, 'officialTitle': 'Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults', 'orgStudyIdInfo': {'id': '1/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single visit 4-site ID vaccination', 'description': 'Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.', 'interventionNames': ['Procedure: Blood drawn after rabies booster vaccination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional IM vaccination', 'description': 'Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.', 'interventionNames': ['Procedure: Blood drawn after rabies booster vaccination']}], 'interventions': [{'name': 'Blood drawn after rabies booster vaccination', 'type': 'PROCEDURE', 'description': 'Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.', 'armGroupLabels': ['Conventional IM vaccination', 'single visit 4-site ID vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'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': '132'}], 'facility': 'Queen Saovabha Memorial Institute', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], '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': '132'}], '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': 'Medical doctor', 'investigatorFullName': 'Suda Sibunruang', 'investigatorAffiliation': 'Queen Saovabha Memorial Institute'}}}}