💉 Study for world's first tuberculosis vaccine in 100 years reaches recruitment target earlier than expected

• The clinical trial of potentially first new tuberculosis vaccine in a century has successfully recruited all 20,000 participants several months earlier than planned.
• The M72/AS01E vaccine showed 50 percent effectiveness in earlier phase 2 studies, which could reduce millions of tuberculosis cases globally.
• The study is being conducted in five countries: South Africa, Kenya, Malawi, Zambia, and Indonesia, with funding from the Gates Foundation and Wellcome Trust.

Rapid recruitment thanks to strong local engagement

The clinical trial of the M72/AS01E vaccine, which could become the world's first new tuberculosis vaccine in a hundred years, has reached its recruitment target earlier than expected. The study started last March and has now successfully recruited the 20,000 participants needed for the study.

The study is being conducted at 54 sites in five countries: South Africa, Kenya, Malawi, Zambia, and Indonesia. Originally, the sponsors estimated it would take up to two years to complete recruitment, but this goal has been reached considerably earlier.

Vaccine that could save millions of lives

Tuberculosis, which is a bacterial infection, still kills over a million people annually. It is estimated that perhaps a quarter of the global population has a latent infection, meaning they carry the bacteria without being sick, but some of them will eventually develop serious illness.

The two-dose M72 vaccine is designed to prevent adolescents and adults from developing the dangerous stage of an infection. The existing tuberculosis vaccine, called BCG and dating back to 1921, can protect infants and young children against severe tuberculosis, but is not particularly effective in older people.

In a previous phase 2 study, the vaccine achieved an effectiveness of 50 percent. Researchers emphasize that a tool that is 50 percent effective at reducing pulmonary tuberculosis could still have dramatic effects, given that there are millions of cases each year.

Focus on areas with high prevalence of tuberculosis

Those involved in the study explain the rapid recruitment rate by noting that the study was designed to focus on sites in areas that previous epidemiological studies had identified as tuberculosis hotspots.

Tuberculosis is so widespread in these communities that many people were eager to participate in the study, having personal understanding of the potential impact of being able to prevent cases.

Funding and future prospects

The vaccine study is funded by the Gates Foundation and Wellcome Trust. The Gates Medical Research Institute, which is a subsidiary of the foundation, is leading the development of the vaccine, which includes an adjuvant - an ingredient that can enhance the immune response a vaccine elicits.

The study is expected to take three to five years, although it will depend on how quickly cases of pulmonary tuberculosis develop among participants, some of whom will receive the vaccine and others placebo.

Despite the study still being in progress, the vaccine's backers are already beginning to plan for potential regulatory approval, manufacturing efforts, and an eventual rollout - including decisions on which groups to target and where to launch it first.

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