South Africa: Funding Secured for Massive TB Vaccine Trial

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Funding Secured for Massive TB Vaccine Trial SpotlightNSP: SouthAfrica

The vaccine, called M72/AS01E or just M72, made headlines in September 2018 when it was found to offer 54% protection against pulmonary TB disease in a phase 2B trial. That trial, of around 3 300 people, was conducted in South Africa, Zambia, and Kenya. Final results from that study were published in the New England Journal of Medicine in 2019 –- efficacy in these final results was down to around 50%.

They said the trial will “assess the candidate vaccine’s efficacy at preventing progression from latent TB infection to pulmonary TB”. In an online media conference on Wednesday Trevor Mundel, President for Global Health at BMGF, clarified that while most study participants will be people with latent TB infection, 4 000 people without TB infection would also be recruited.

According to the statement, additional details about the trial design and participants will be announced in the coming months. As pointed out in the statement, the only TB vaccine in use today, bacille Calmette-Guerin , was first given to people in 1921. It helps protect babies and young children against severe systemic forms of TB but offers limited protection against pulmonary TB among adolescents and adults. If the findings from the phase 3 trial of M72 are positive, m72 will become the first new TB vaccine in over a hundred years to be proven safe and effective.

 

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$550-MILLION STUDY : South Africa included in Gates-led clinical trial of new TB vaccine hailed as potential game-changerA Phase 3 clinical trial for M72, a new candidate vaccine against pulmonary tuberculosis will be conducted in South Africa. The head of Global Health at the Bill & Melinda Gates Foundation, Dr Trevor Mundel, said this week that they were very optimistic that it would be an effective and safe vaccine. However, this will be determined by the success of the Phase 3 trials.
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