SOUTH AFRICA—The Bill & Melinda Gates Medical Research Institute (Gates MRI), a nonprofit organization and subsidiary of the Bill & Melinda Gates Foundation, has launched a Phase 3 clinical trial to evaluate the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate.

At full capacity, the trial will encompass up to 20,000 participants, including individuals living with HIV, across approximately 60 trial sites spanning seven countries—South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam.

This trial is particularly critical in South Africa, where TB takes a significant toll, with approximately 280,000 people diagnosed with TB annually.

Participants will be randomly assigned to receive either the investigational M72/AS01E vaccine or a placebo in a double-blind trial, ensuring unbiased evaluation of the vaccine’s safety and efficacy—the gold standard in vaccine assessment.

GlaxoSmithKline (GSK), a British multinational pharmaceutical and biotechnology business, has been developing the M72/AS01E vaccine candidate since the early 2000s.

GSK, in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI), conducted clinical evaluations up to the proof-of-concept phase (Phase 2b), with funding from GSK and the Gates Foundation.

In 2020, GSK partnered with the Gates MRI for further development of M72/AS01E. GSK continues to provide technical assistance and supplies the adjuvant component of the vaccine for the Phase 3 trial. This underscores their commitment to combating TB.

Emilio A. Emini, Ph.D., CEO of the Gates MRI, emphasized the institute’s commitment to leveraging medical innovation to combat diseases like TB, which disproportionately affect low- and middle-income countries.

He expressed gratitude for the collaborative efforts of partners across South Africa and beyond.

On her part, Dr. Lee Fairlie, the national principal investigator for the trial in South Africa, underscored the milestone significance of advancing to Phase 3, highlighting South Africa’s extensive experience in TB-related clinical trials and its dedication to patient safety and generating high-quality data essential for regulatory approvals.

Deborah Waterhouse, CEO of ViiV Healthcare and President of Global Health at GSK, expressed enthusiasm for GSK’s efforts over two decades in developing this crucial vaccine candidate, which is now undergoing Phase 3 trials.

She emphasized the transformative power of collaboration with partners like the Gates MRI, Wellcome, and the Gates Foundation in tackling challenging diseases such as TB.

Alemnew Dagnew, M.D., who leads the development of M72/AS01E at the Gates MRI, highlighted the potential of the vaccine to revitalize the global fight against TB, particularly in the wake of the COVID-19 pandemic, which has weakened efforts in this area.

Trevor Mundel, President of Global Health at the Bill & Melinda Gates Foundation, underscored the urgency of developing and delivering innovative tools to transform TB prevention, diagnosis, and treatment.

Alex Pym, Director of Infectious Disease at Wellcome, emphasized the significance of starting the trial in South Africa as a critical step toward developing an effective vaccine to protect those most at risk of TB.

TB remains one of the deadliest infectious diseases globally, with the only available vaccine, BCG, offering limited protection against pulmonary TB—the primary form responsible for transmission.

With over 10.6 million TB cases reported in 2022, the need for an effective vaccine is paramount, especially for vulnerable populations in low- and middle-income countries.

Ensuring vaccine accessibility and affordability for communities in high disease burden areas is a priority for all trial partners. The Gates MRI has collaborated closely with various stakeholders, including communities around trial sites, to guide the TB candidate vaccine to Phase 3.

The trial is expected to last up to five years, followed by data analysis and the submission of data to regulatory authorities. The World Health Organization estimates that over 25 years, this level of protection could save millions of lives and prevent millions of new TB cases, providing significant benefits for affected households.

In GSK’s Phase 2b trial, M72/AS01E provided approximately 50% protection against progression to active pulmonary TB in Mycobacterium tuberculosis-infected HIV-negative adults, offering unprecedented potential in TB vaccine research.

If proven well-tolerated and effective, M72/AS01E could become the first vaccine to help prevent pulmonary TB in adolescents and adults, marking a significant milestone in TB prevention and the first new TB vaccine in over a century.

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