drugset / Trial / NCT06062238
Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults
Phase 3
Active not recruiting
20080 enrolled
Gates Medical Research Institute
Bill and Melinda Gates Foundation · collabWellcome Trust · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-03-05
- Primary completion
- 2028-04
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | M72/AS01E-4 | Vaccine | — | Intramuscular |