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Wits RHI

M72 TB Vaccine Study (Gates MRI-TBV02-301)

Infectious Diseases

Project Title

Gates MRI-TBV02-301 (M72): Phase 3 Tuberculosis Vaccine Trial

Overview

The Gates MRI-TBV02-301 (M72) study is a large-scale Phase 3 clinical trial evaluating the efficacy, safety, and immune response of the investigational M72/AS01E tuberculosis (TB) vaccine in adolescents and adults. The study aims to determine whether this vaccine can help prevent pulmonary tuberculosis, one of the world’s leading infectious diseases, including among populations at higher risk.

Rationale

Tuberculosis remains a major global health challenge, particularly in high-burden settings. In a previous Phase 2b trial, the M72/AS01E vaccine demonstrated approximately 50% protection against active pulmonary TB disease in adults. This Phase 3 study builds on those findings to:

  • Confirm the vaccine’s protective efficacy in a larger population
  • Evaluate its effectiveness in both TB-infected and uninfected individuals
  • Generate critical safety and immunogenicity data, including among people living with HIV

The study is a key step toward developing a new, effective TB vaccine, which could significantly reduce TB incidence and mortality globally.

Study Aim

To determine whether the M72/AS01E vaccine is safe and effective in preventing tuberculosis infection and disease in adolescents and adults.

Primary Objective

  • Evaluate the vaccine efficacy in preventing laboratory-confirmed pulmonary TB among TB-infected (IGRA-positive), HIV-negative participants

Secondary Objectives

  • Assess vaccine efficacy in preventing TB infection and disease in TB-uninfected participants
  • Evaluate effectiveness among people living with HIV
  • Assess long-term safety and reactogenicity
  • Measure immune response to vaccination

Investigators

  • Prof Lee Fairlie – Principal Investigator
  • Dr Faeezah Patel – Sub-Investigator
  • Dr Elizea Horne – Sub-Investigator
  • Dr Mrinmayee Dhar
  • Dr Jeanne Coetzee
  • Tiffany Seef

Latest Updated: March 2026

For more details about the Gates MRI-TBV02-301 Study please email rhicomms@wrhi.ac.za

Click here for further details regarding the Gates MRI-TBV02-301 Study.

Project Brief

M72 TB Vaccine Study (Gates MRI-TBV02-301)