Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-31 @ 5:19 PM
Study NCT ID:
NCT02097095
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Specimens for this sub-study are collected from an interventional Phase 2 study (TB-018 see NCT 01755598) and later analyzed for correlates of risk to tuberculosis.\n\nPBMC/Plasma; Whole Blood cell count; Intracellular RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3253}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collect and store biological samples for future use to evaluate potential biological markers correlated to the risk for tuberculosis.', 'timeFrame': '36 months in parallel with main study TB-018 (NCT01755598).', 'description': 'Additional blood samples will be collected from participants that have agreed to be in this sub-study of TB-018 (NCT01755598).'}], 'secondaryOutcomes': [{'measure': 'Collect and store biological samples for future use to evaluate immune correlates of protection from tuberculosis in subjects vaccinated with GSK 692342 (M72/AS01E).', 'timeFrame': '36 months in parallel with main study TB-018 (NCT01755598).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Correlates of risk', 'TB', 'Tuberculosis', 'Sub-study', 'TB-018'], 'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': 'This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which biological samples will be collected for future investigations on biological correlates, markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, "A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals\' candidate tuberculosis (TB) vaccine GSK 692342 (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region", (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but will have additional blood samples collected for the sub-study.', 'detailedDescription': 'Additional information in the protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have consented to participate in TB-018 will be approached for participation in this sub-study. Subjects who have consented to participate in TB-018 are not required to participate in this sub-study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for inclusion criteria into TB-018.\n\nExclusion criteria:\n\nTo be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for exclusion criteria into TB-018.'}, 'identificationModule': {'nctId': 'NCT02097095', 'briefTitle': 'Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)', 'organization': {'class': 'OTHER', 'fullName': 'Aeras'}, 'officialTitle': 'Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis', 'orgStudyIdInfo': {'id': 'C-041-972'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccine group', 'description': 'TB vaccine GSK 692342 (M72/AS01E) administered on study TB-018'}, {'label': 'Placebo Comparator', 'description': 'Placebo administered on study TB-018'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bernard Landry, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aeras'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aeras', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}