Vaccine Targeting Tuberculosis (TB) Prevention Enters its Phase 3 Trial


The Bill & Melinda Gates Medical Research Institute launches the M72/AS01E vaccine in South Africa to combat TB.

TB Vaccine | Image credits: Unsplash

The Bill & Melinda Gates Medical Research Institute (Gates MRI) revealed the commencement of phase 3 clinical trial evaluating the M72/AS01E TB vaccine candidate, with initial doses administered in South Africa. Should M72/AS01E prove to be both safe and productive, it has the potential to be the inaugural vaccine aimed at preventing pulmonary TB in adolescents and adults, marking the introduction of the first new TB vaccine in more than 100 years. This vaccine could reduce the incidence of TB, particularly pulmonary TB, which is the most common and contagious form of the disease, contributing significantly to global health efforts to combat this deadly disease.

The earlier phase 2b trial results indicated that M72/AS01E provided significant protection against the progression to active pulmonary TB. This efficacy, unprecedented in decades of TB vaccine research, has paved the way for the expansive phase 3 trial. The World Health Organization (WHO)-commissioned study projects that a vaccine with 50% efficacy could, over 25 years, prevent 76 million new TB cases and save 8.5 million lives, demonstrating the potential impact of the M72/AS01E vaccine.

“The launch of this pivotal phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries,” said Emilio A. Emini, PhD, CEO of the Gates MRI. “Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the phase 3 study share our hope in the vaccine’s potential.”

Main Takeaways

  1. Gates MRI has initiated a phase 3 clinical trial for the M72/AS01E TB vaccine candidate in South Africa.
  2. Preliminary results from a phase 2b trial showed the M72/AS01E vaccine to be effective in providing significant protection against active pulmonary TB, a breakthrough in TB vaccine research.
  3. Success in this trial could significantly advance the global fight against TB, particularly benefiting low- and middle-income countries that bear the brunt of the disease.

The study focuses on the phase 3 clinical trial assessing the efficacy of the M72/AS01E TB vaccine candidate in preventing the progression from latent TB infection to active pulmonary TB in adolescents and adults. This trial builds on the results of a phase 2b trial, where the vaccine showed approximately 50% protection against active pulmonary TB in HIV-negative adults. The M72/AS01E vaccine is an adjuvanted recombinant protein vaccine, leveraging antigens selected for their strong immune response potential. The trial is being conducted across 7 countries, including South Africa, Zambia, and Kenya, involving up to 20,000 participants aged 15 to 44, with varying HIV and TB infection statuses.

“If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic,” said Alemnew Dagnew, MD, who leads the development of M72/AS01E at the Gates MRI. “I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities — and a vaccine that could help prevent that from happening would be transformative.”

The WHO reports that approximately 10.6 million individuals contracted TB in 2022, with 1.3 million fatalities, translating to more than 3,500 deaths daily. TB predominantly impacts individuals in low- and middle-income nations, particularly those facing poverty, inadequate living and working environments, and malnutrition. Specifically, South Africa reports about 280,000 new TB cases annually.

“While it is a long journey to results, the start of this trial in South Africa brings us a critical step closer to having an effective vaccine to protect those most at risk of TB,” says Alex Pym, Director of Infectious Disease at Wellcome. “Global collaboration with regulators, in-country decision makers and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be successful.”

In conclusion, completing the M72/AS01E TB vaccine's Phase 3 trial is anticipated to take up to 5 years to complete, followed by data analysis and then preparation for submission of data to regulatory authorities.


1. Institute B& MGMR. Bill & Melinda Gates Medical Research Institute Initiates Phase 3 Clinical Trial of Tuberculosis Vaccine Candidate. PRNEWSWIRE. Published March 19, 2024. Accessed March 19, 2024.

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