Clinical Trial

Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2023-09-25; most recent amendment 2026-04-22.
Status change: Recruiting → Active, Not Recruiting 2025-05-15
Status change: Not Yet Recruiting → Recruiting 2024-03-19
Trial Details
NCT Number NCT06062238
Lead Sponsor Gates Medical Research Institute
Collaborators: Wellcome Trust, Bill and Melinda Gates Foundation
Conditions Tuberculosis
Enrollment 20,080 participants
Start Date 2024-03-05
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-27