Bill & Melinda Gates Medical Research Institute (Gates MRI) has commenced the third phase clinical trial for the M72/AS01E tuberculosis (TB) vaccine candidate, aiming to combat the prevalent disease.
Potential Breakthrough in TB Prevention
The vaccine, administered in South Africa where TB imposes a significant burden, could potentially become the first vaccine to prevent pulmonary TB in adolescents and adults, if proven effective and well-tolerated.
Addressing a Century-Old Challenge
With the last TB vaccine, Bacilli Calmette-Guerin (BCG), dating back to 1921 and being inadequate for adolescents and adults against pulmonary TB, this trial could mark a significant advancement in TB prevention.
Global Impact of TB
The World Health Organisation reports staggering numbers, with 10.6 million TB cases and 1.3 million deaths globally in 2022, while South Africa alone witnesses around 280,000 diagnoses annually.
Extensive Trial Scope
The trial, spanning five years and involving up to 20,000 participants across seven countries, aims to evaluate the safety and efficacy of the M72/AS01E vaccine candidate, including individuals living with HIV.
Gold Standard Evaluation
Using a double-blind trial methodology, the study ensures rigorous evaluation, with neither participants nor clinical investigators aware of who receives the vaccine or placebo, considered the gold standard in vaccine trials.
Collaborative Efforts and Funding
Sponsored by Gates MRI and supported by funding from the Gates Foundation and Wellcome, the trial represents a culmination of collaborative efforts spanning decades in TB vaccine research.
Potential for Life-Saving Impact
Previous trials indicate promising results, with M72/AS01E offering approximately 50% protection against progression to active pulmonary TB in HIV-negative adults, potentially saving millions of lives and billions in healthcare costs.
A Hopeful Future
Emphasizing the importance of medical innovation, CEO of Gates MRI, Emilio Emini, underscores the commitment to fighting diseases like TB, particularly devastating for low- and middle-income countries.
Reinvigorating Global TB Efforts
Alemnew Dagnew, leading the development of M72/AS01E, highlights the potential of the vaccine to reinvigorate the global fight against TB, especially amidst challenges posed by the COVID-19 pandemic.
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Credit: Doris Chinwe Omemgbeoji