NCT06062238

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial to Assess the Prophylactic Efficacy, Safety, and Immunogenicity of the Investigational M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine When Administered Intramuscularly on a 0,1-month Schedule to Adolescents and Adults

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20,080 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 15 Years – 44 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine	Participants will receive an intramuscular dose of M72 (recombinant fusion protein) reconstituted with AS01E-4 (an adjuvant system), on Day 1 and Day 29.
BIOLOGICAL	Placebo	Participants will receive an intramuscular dose of normal saline (0.9 percent \[%\] sodium chloride \[NaCl\]), on Day 1 and Day 29.

Timeline

• Start date: 2024-03-05
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-10-02
• Last updated: 2026-02-12

Locations

54 sites across 5 countries: Indonesia, Kenya, Malawi, South Africa, Zambia