Gates Foundation Initiates Phase 3 Trial for Tuberculosis Vaccine Candidate

The Bill & Melinda Gates Medical Research Institute (Gates MRI) announced the start of a Phase 3 clinical trial to evaluate a new tuberculosis (TB) vaccine candidate, M72/AS01E. This is a significant step in the fight against TB, a major global health threat.

Here’s a summary of the key points:

  • Urgent Need for New Vaccine: TB is a leading cause of death worldwide, especially among people with HIV. The only existing TB vaccine, BCG, is over 100 years old and offers limited protection for adults.
  • Promising Candidate: M72/AS01E has been in development for over 20 years and showed promising results in earlier trials.
  • Large-Scale Trial: The Phase 3 trial will involve up to 20,000 participants in seven countries, including South Africa, Zambia, and Vietnam.
  • Focus on Accessibility: The Gates MRI and partners are committed to ensuring the vaccine is affordable and accessible in low- and middle-income countries most affected by TB.
  • Long-Term Goal: If successful, this vaccine could be a game-changer in preventing TB and saving millions of lives.


  • The trial is expected to take up to five years to complete, followed by regulatory review.
  • It could be several years before the vaccine becomes widely available.


  • The Gates MRI is leading the trial with funding from the Gates Foundation and Wellcome.
  • GSK, a pharmaceutical company, is providing technical assistance and vaccine components.

Overall, this Phase 3 trial represents a major step forward in the development of a new and effective TB vaccine.

Posted March 2024.

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