A new tuberculosis (TB) vaccine candidate, M72/AS01E, has entered Phase III clinical trials, with Kenyans among the 20,000 global participants enrolled by the Gates Medical Research Institute (Gates MRI).
Pharmaceutical giant GSK announced on Wednesday, July 30, that the Phase III trial of its TB vaccine candidate, M72/AS01E, is underway across 54 sites in five countries: Kenya, South Africa, Zambia, Malawi, and Indonesia.
The trial involves over 20,000 adolescent and adult participants and finished enrolling participants 11 months ahead of schedule.
This large-scale clinical trial is testing the effectiveness of the vaccine candidate in preventing pulmonary TB in adults who have already been infected with Mycobacterium tuberculosis but do not yet show active disease.
If successful, this could become the first new TB vaccine in over a century, significantly altering the global TB response.
“The phase III clinical trial of M72/AS01E, a tuberculosis (TB) vaccine candidate originally developed by GSK and sponsored by Gates Medical Research Institute with funding support from the Gates Foundation and Wellcome, has completed full enrollment of 20,000 participants, 11 months ahead of schedule.
“The trial is taking place at 54 sites across sites in South Africa, Kenya, Malawi, Zambia, and Indonesia. If proven effective, M72 could potentially become the first new tuberculosis vaccine that meets the World Health Organization’s target product profile for over 100 years,” stated GSK.
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Who is Funding the Clinical Trial
The Phase III trial is being sponsored by the Gates Medical Research Institute (Gates MRI), a non-profit arm of the Gates Foundation, and is funded by Wellcome and the Gates Foundation, who are jointly investing $550 million (Ksh72.5 billion).
According to the foundation, the trial could lead to the first new TB vaccine in over a century, potentially transforming prevention efforts against one of the world’s deadliest infectious diseases.
“TB remains one of the world’s deadliest infectious diseases. Greater investment in safe and effective TB vaccines alongside a suite of new diagnostics and treatments could transform TB care for millions,” Bill Gates, Co‑chair of the Gates Foundation stated.
According to GSK, the World Health Organization (WHO) estimates that a TB vaccine with 50% efficacy in adolescents and adults could prevent up to 76 million new TB cases and 8.5 million deaths by 2050.
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How the Contribution from Kenyans Will Benefit the World
Additionally, the National Tuberculosis, Leprosy and Lung Disease Program (NTLD-P) has acknowledged the need for better tools, including vaccines, to support the country’s TB elimination efforts.
The current BCG vaccine used in children offers limited protection against adult pulmonary TB, the most infectious form of the disease.
GSK’s M72/AS01E vaccine candidate showed promising results in earlier Phase IIb trials, with 50% efficacy in preventing active TB in infected individuals.
The current Phase III trial aims to confirm these findings at a larger scale and across multiple geographies.
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