Trial for Tuberculosis Vaccine Begins in South Africa

19 March 2024

On 19 March 2024, a significant milestone was reached in the global fight against tuberculosis (TB) as the first jabs of an experimental TB vaccine were administered at a clinical trial site affiliated with Wits RHI in Johannesburg, South Africa. This trial marks the commencement of a large Phase 3 study aimed at evaluating the efficacy of the M72/AS01E vaccine candidate in protecting older adolescents and adults from pulmonary tuberculosis.

Leading this crucial trial are Prof Lee Fairlie, Wits RHI’s Director of Maternal and Child Health, and Prof Willem Hanekom from AHRI (Africa Health Research Institute), who serve as the Co-National Principal Investigators for the TB trial in South Africa. The trial, conducted at the Wits RHI clinical trial site, is the first of a planned 60 sites across seven countries.

The M72/AS01E vaccine candidate, if proven effective, could become the first new TB vaccine in a century, offering a beacon of hope in the battle against this persistent and debilitating disease. Up to 20,000 individuals are anticipated to participate in the study, with South Africa expected to contribute significantly, hosting between 50% and 60% of the study participants.

Dr. Lee Fairlie expressed the importance of this milestone, stating, “Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities.” South Africa’s expertise in TB- and vaccine-related clinical trials, coupled with its commitment to patient safety and data quality, positions it as a vital player in advancing TB prevention strategies.

Official Press Release:

Bill & Melinda Gates Medical Research Institute

The Wellcome Trust

This groundbreaking trial has garnered attention from various media outlets, including the local news platforms such as Spotlight, News 24, Radio 702, SAFM, and SABC News. Prof Fairlie’s insights into the M72 study and its potential impact on TB prevention highlight the significance of this initiative as a potential game-changer in global health.

As the trial progresses, stakeholders remain hopeful that this vaccine candidate will prove its efficacy, paving the way for a new era in TB prevention and control, not only in South Africa but worldwide.

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