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

NCT06062238 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20080

Last updated 2026-04-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Gates Medical Research Institute

    lead OTHER

Principal Investigators

  • Gates MRI · Gates Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • Indonesia
  • Kenya
  • Malawi
  • South Africa
  • Zambia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06062238 on ClinicalTrials.gov