protocolSection identificationModule nctId: NCT06272812, orgStudyIdInfo id: IAVI C113, briefTitle: A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: International AIDS Vaccine Initiative, class: NETWORK, collaborators name: Biofabri, SLU, collaborators name: Universidad de Zaragoza, descriptionModule briefSummary: A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region., conditionsModule conditions: Tuberculosis (TB), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4300, type: ESTIMATED, armsInterventionsModule interventions name: MTBVAC, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the protective efficacy of of MTBVAC against bacteriologically confirmed pulmonary TB disease, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment as compared to placebo., secondaryOutcomes measure: To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo., secondaryOutcomes measure: To evaluate the protective efficacy of MTBVAC candidate vaccine against definite Xpert MTB/RIF Ultra positive pulmonary TB disease diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo., secondaryOutcomes measure: To evaluate the protective efficacy of one dose of MTBVAC candidate vaccine against clinical TB, as compared to placebo, secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine., secondaryOutcomes measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants., secondaryOutcomes measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants., eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False