The Bill & Melinda Gates Medical Research Institute (Gates MRI) has dosed the first patient cohort in a Phase III clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate.

The dosed cohort was enrolled in sites across South Africa. The randomised, placebo-controlled Phase III trial (NCT06062238) will evaluate the prophylactic efficacy, safety, and immunogenicity of the TB vaccine. The study is expected to enrol up to 20,000 participants across 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam.

The trial is being funded by the Bill & Melinda Gates Foundation and the Wellcome Trust (UK).

The participants will be divided into three cohorts, notably interferon-gamma release assay (IGRA)-positive, IGRA-negative, and human immunodeficiency virus (HIV) cohort. The IGRA test detects the presence of TB causing mycobacterium tuberculosis (MTB) in the blood.

Volunteers will receive two doses of either the vaccine or placebo, administered one month apart. Vaccine efficacy will be determined by the prevention of bacteriologically confirmed pulmonary TB among people with IGRA-positive TB.

The M72/AS01E vaccine is an adjuvanted recombinant protein vaccine that consists of a 72kDa recombinant fusion protein derived from two MTB antigens. The vaccine adjuvant is provided by GSK.

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The Phase II trial (NCT04556981) for the vaccine found that it provided approximately 50% protection against progression to active pulmonary tuberculosis for three years in MTB-infected HIV-negative adults.

TB has a high global burden, with the World Health Organization (WHO) estimating that 10.6 million people contracted TB in 2022 and of these 1.3 million died. The illness primarily affects low and middle-income countries such as Bangladesh, China, and the Democratic Republic of the Congo.

The Jenner Institute at the University of Oxford, UK, is investigating a new administration route for the only available TB vaccine, the Bacillus Calmette-Guérin (BCG) vaccine. The BCG is part of vaccinations administered to babies and young children to protect them against severe forms of the disease such as TB meningitis.

This January, the Jenner Institute launched a trial investigating the potential benefits of administering the BCG vaccine for TB via inhalation. The study will enrol healthy subjects both with and without type 2 diabetes (T2D) who have previously received the BCG vaccine. It will also assess the immune response in individuals with T2D, who are at an increased risk of contracting TB.