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Wits RHI

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

Infectious Diseases

This is a Phase 3, randomized, double-blind, placebo-controlled, multicentre clinical trial evaluating the efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine. The study focuses on preventing tuberculosis (TB) in adolescents and adults aged 15 to 44 years.

Study Rationale

Tuberculosis (TB) remains a significant global public health challenge, especially in high-burden settings. In a prior Phase 2b trial, the M72/AS01E-4 vaccine demonstrated approximately 50% efficacy over 36 months in preventing pulmonary TB among adults who tested positive for interferon gamma release assay (IGRA) and were HIV-negative.

The Phase 3 Gates MRI-TBV02-301 study aims to confirm this efficacy in a larger population and to assess the vaccine’s safety and immune response across a broader group, including IGRA-negative individuals and people living with HIV (PLHIV). The goal is to provide robust evidence to support global policy decisions on TB vaccine deployment.

Study Objectives

Primary Objective

  • To evaluate the efficacy of M72/AS01E-4 in preventing laboratory-confirmed pulmonary TB in IGRA-positive, HIV-negative participants.

Secondary Objectives

  • To assess vaccine efficacy (VE) in preventing:

    • Mtb infection among IGRA-negative participants.

    • Pulmonary TB among IGRA-negative participants and PLHIV.

    • TB using a less stringent definition among IGRA-positive participants.

  • To evaluate the safety and tolerability of the vaccine.

  • To assess humoral immune responses post-vaccination.

Primary & Secondary Endpoints

Primary Endpoint:

  • VE against laboratory-confirmed pulmonary TB in IGRA-positive, HIV-negative individuals, calculated using a Cox proportional hazards model.

Secondary Endpoints:

  • VE against Mtb infection and TB in IGRA-negative and HIV-positive participants.

  • Seropositivity rates and geometric mean concentrations (GMCs) of M72-specific antibodies at multiple follow-up time points.

  • Safety and reactogenicity of the vaccine.

Investigators

  • Principal Investigator: Prof Lee Fairlie

  • Sub-Investigators:

    • Dr Faeezah Patel

    • Dr Elizea Horne

    • Dr Mrinmayee Dhar

    • Dr Jeanne Coetzee

    • Tiffany Seef

Latest Updated

May 2025

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)