Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults
- Conditions
- Tuberculosis
- Interventions
- Biological: PlaceboBiological: M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine
- Registration Number
- NCT06062238
- Lead Sponsor
- Bill & Melinda Gates Medical Research Institute
- Brief Summary
The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA-Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20081
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants receiving placebo Placebo - Participants receiving M72/AS01E-4 M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine -
- Primary Outcome Measures
Name Time Method IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB) Up to Month 49 Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weight loss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding "trace positive"), from the same or from different sputum samples collected during the 3 suspected TB visits, preferably within a 7-day time frame, before initiation of TB treatment.
- Secondary Outcome Measures
Name Time Method HIV Cohort: Number of participants with laboratory-confirmed pulmonary TB Up to Month 49 IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary TB (Less stringent laboratory-confirmed pulmonary TB case definition) Up to Month 49 Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weight loss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has at least 1 positive Mtb culture or at least 1 positive result from Xpert Ultra or similar assay (excluding "trace positive"), from the same or from different sputum samples collected during the 3 suspected TB visits, preferably within a 7-day time frame, before initiation of TB treatment.
ComposeAll Cohorts: Number of participants with serious adverse events (SAEs) Up to Month 13 IGRA-Negative Cohort: Number of participants with sustained QuantiFERON®-TB Gold Plus assay conversion Up to Month 49 All Cohorts: Number of participants with potential immunemediated diseases (pIMDs) Up to Month 13 All Cohorts: Number of participants with SAEs related to trial participation Up to Month 49 All Cohorts: Number of participants with unsolicited AEs Up to 28 days IGRA-Negative Cohort: Number of participants with laboratory-confirmed pulmonary TB Up to Month 49 All cohorts: Number of participants with seropositivity of M72-specific antibodies At Day 1, Month 1, Month 2, Month 7, Month 13, Month 37, and Month 49 All Cohorts: Number of participants with solicited adverse events (AEs) Up to 7 days All cohorts: Number of participants with geometric mean concentration (GMC) of M72-specific antibodies At Day 1, Month 1, Month 2, Month 7, Month 13, Month 37, and Month 49
Trial Locations
- Locations (54)
1209-Gates MRI Investigational Site
🇰🇪Nairobi, Kenya
1201-Gates MRI Investigational Site
🇰🇪Nairobi, Kenya
2402-Gates MRI Investigational Site
🇲🇼Chichiri, Malawi
2401-Gates MRI Investigational Site
🇲🇼Lilongwe, Malawi
1033-Gates MRI Investigational Site
🇿🇦Bloemfontein, South Africa
1016-Gates MRI Investigational Site
🇿🇦Brits, South Africa
1021-Gates MRI Investigational Site
🇿🇦Cape Town, South Africa
1024-Gates MRI Investigational Site
🇿🇦Cape Town, South Africa
1006-Gates MRI Investigational Site
🇿🇦Cape Town, South Africa
1003-Gates MRI Investigational Site
🇿🇦Cape Town, South Africa
2202-Gates MRI Investigational Site
🇮🇩Jakarta, Indonesia
2205-Gates MRI Investigational Site
🇮🇩Jakarta, Indonesia
2203-Gates MRI Investigational Site
🇮🇩Jakarta, Indonesia
1205-Gates MRI Investigational Site
🇰🇪Eldoret, Kenya
1203-Gates MRI Investigational Site
🇰🇪Homa Bay, Kenya
1206-Gates MRI Investigational Site
🇰🇪Kericho, Kenya
1207-Gates MRI Investigational Site
🇰🇪Kilifi, Kenya
1202-Gates MRI Investigational Site
🇰🇪Kisumu, Kenya
1208-Gates MRI Investigational Site
🇰🇪Machakos, Kenya
1204-Gates MRI Investigational Site
🇰🇪Mombasa, Kenya
2201-Gates MRI Investigational Site
🇮🇩Bandung, Indonesia
2204-Gates MRI Investigational Site
🇮🇩Depok, Indonesia
1034-Gates MRI Investigational Site
🇿🇦Cape Town, South Africa
1022-Gates MRI Investigational Site
🇿🇦Cape Town, South Africa
1008-Gates MRI Investigational Site
🇿🇦Cape Town, South Africa
1009-Gates MRI Investigational Site
🇿🇦Durban, South Africa
1026-Gates MRI Investigational Site
🇿🇦Durban, South Africa
1029-Gates MRI Investigational Site
🇿🇦Durban, South Africa
1010-Gates MRI Investigational Site
🇿🇦East London, South Africa
1028-Gates MRI Investigational Site
🇿🇦Johannesburg, South Africa
1031-Gates MRI Investigational Site
🇿🇦Johannesburg, South Africa
1018-Gates MRI Investigational Site
🇿🇦Johannesburg, South Africa
1020-Gates MRI Investigational Site
🇿🇦Johannesburg, South Africa
1007-Gates MRI Investigational Site
🇿🇦Johannesburg, South Africa
1014-Gates MRI Investigational Site
🇿🇦Jouberton, South Africa
1027-Gates MRI Investigational Site
🇿🇦Kimberley, South Africa
1017-Gates MRI Investigational Site
🇿🇦Klerksdorp, South Africa
1012-Gates MRI Investigational Site
🇿🇦Ladysmith, South Africa
1004-Gates MRI Investigational Site
🇿🇦Middelburg, South Africa
1002-Gates MRI Investigational Site
🇿🇦Mtubatuba, South Africa
1001-Gates MRI Investigational Site
🇿🇦Paarl, South Africa
1013-Gates MRI Investigational Site
🇿🇦Port Elizabeth, South Africa
1005-Gates MRI Investigational Site
🇿🇦Pretoria, South Africa
1019-Gates MRI Investigational Site
🇿🇦Rustenburg, South Africa
1011-Gates MRI Investigational Site
🇿🇦Soweto, South Africa
1015-Gates MRI Investigational Site
🇿🇦Soweto, South Africa
1025-Gates MRI Investigational Site
🇿🇦Tembisa, South Africa
1032-Gates MRI Investigational Site #1
🇿🇦Tembisa, South Africa
1030-Gates MRI Investigational Site
🇿🇦Vereeniging, South Africa
1023-Gates MRI Investigational Site
🇿🇦Worcester, South Africa
1302-Gates MRI Investigational Site
🇿🇲Lusaka, Zambia
1303-Gates MRI Investigational Site
🇿🇲Lusaka, Zambia
1301-Gates MRI Investigational Site
🇿🇲Lusaka, Zambia
1304-Gates MRI Investigational Site
🇿🇲Ndola, Zambia