MTBVAC
Sponsors
Biofabri, S.L, International AIDS Vaccine Initiative, HIV Vaccine Trials Network, Bharat Biotech International Limited, BIOFABRI S.L.U.
Conditions
HIV I InfectionTuberculosisTuberculosis (TB)
Phase 1
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
CompletedNCT02729571
Start: 2015-09-30End: 2018-03-31Updated: 2018-05-01
MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa
CompletedNCT02933281
Start: 2018-05-14End: 2021-09-05Updated: 2023-02-27
Phase 2
Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates
CompletedNCT03536117
Start: 2019-02-12End: 2022-05-17Updated: 2025-04-27
Evaluating the Safety and Immunogenicity of MTBVAC
RecruitingNCT05947890
Start: 2024-01-30End: 2027-04-05Target: 276Updated: 2026-03-12
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
RecruitingNCT06272812
Start: 2025-02-19End: 2028-03-31Target: 5500Updated: 2026-03-31
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
RecruitingNCT06997367
Start: 2025-03-01End: 2026-06-30Target: 164Updated: 2025-05-30
Phase 3
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
RecruitingNCT04975178
Start: 2022-10-17End: 2029-02-28Target: 7120Updated: 2025-02-10
203, MTBVAC Protocol (referred to as MTBVAC-203)
RecruitingPACTR202111682972355
Start: 2022-01-10Target: 7120Updated: 2026-01-27