Pharma Focus Asia

Bill & Melinda Gates Medical Research Institute Launches Phase 3 Trial for Tuberculosis Vaccine Candidate

Wednesday, March 20, 2024

The Bill & Melinda Gates Medical Research Institute (Gates MRI) has announced the commencement of a Phase 3 clinical trial to evaluate the effectiveness of the M72/AS01E tuberculosis (TB) vaccine candidate. This significant trial began with the administration of initial doses in South Africa, a country severely affected by TB. The M72/AS01E vaccine has the potential to be the first of its kind, offering prevention against pulmonary TB in adolescents and adults, the most prevalent form of the disease, and serving as the first new TB vaccine in over a century.

Globally, TB remains a substantial health challenge, with an estimated 10.6 million individuals falling ill with the disease in 2022, resulting in 1.3 million deaths annually—translating to over 3,500 deaths per day. TB predominantly impacts populations in low- and middle-income countries, particularly those living in poverty and facing inadequate living conditions, malnutrition, and limited access to healthcare. South Africa alone records approximately 280,000 TB diagnoses annually.

Emilio A. Emini, Ph.D., CEO of the Gates MRI, emphasized the organization's dedication to leveraging medical innovation in combating diseases like TB, especially in regions with limited resources. The Phase 3 trial, although requiring years for completion, signifies a collective commitment towards evaluating the vaccine's potential efficacy, with South Africa serving as a pivotal site.

Sponsored by the Gates MRI, a nonprofit subsidiary of the Bill & Melinda Gates Foundation, and supported by funding from the Gates Foundation and Wellcome, the trial marks the culmination of years of development efforts. Originally developed by GSK, the M72/AS01E vaccine has been in development since the early 2000s, with the Gates MRI partnership initiated in 2020 to further its advancement. GSK continues to provide technical support and vaccine components for the trial, highlighting the collaborative nature of the endeavor.

Ensuring long-term accessibility and affordability of the vaccine is a priority for all stakeholders involved. Through extensive collaboration with communities and partners, the Gates MRI and its collaborators are laying the groundwork for sustainable access post-trial success. This includes understanding potential demand, building evidence for vaccine impact, and collaborating with international partners for effective vaccine introduction and distribution.

The Phase 3 trial, spanning seven countries and involving up to 20,000 participants, adopts a double-blind approach, considered the gold standard for vaccine evaluation. Participants will receive either the M72/AS01E vaccine or a placebo, with neither the participants nor the investigators aware of who receives the vaccine, ensuring unbiased evaluation of safety and efficacy.

The commencement of the Phase 3 trial marks a significant milestone in the fight against TB. Trevor Mundel, President of Global Health at the Bill & Melinda Gates Foundation, underscored the importance of accelerating solutions to address TB's impact on vulnerable communities. While the trial presents a long journey ahead, global collaboration and community engagement remain crucial in realizing the vaccine's potential to save lives and reduce suffering from TB.



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