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Urgent TB vaccine trial kicks off in SA

- Wits Communications

Professor Lee Fairlie from the Wits Reproductive Health and HIV Institute (Wits RHI) is a Co-National Principal Investigator of the trial.

She joins fellow Principal Investigator, Professor Willem Hanekom from the Africa Health Research Institute (AHRI), who will lead the large Phase 3 trial that will evaluate whether the M72/AS01E vaccine candidate can protect older adolescents and adults from pulmonary tuberculosis.

Professor Lee Fairlie from the Wits Reproductive Health and HIV Institute (Wits RHI)

The M72/AS01E vaccine candidate could be the first new TB vaccine in 100 years if proven effective.

The first jabs in a much-anticipated clinical trial of an experimental tuberculosis (TB) vaccine have been administered at a clinical trial site at Wits RHI. Up to 20,000 people are anticipated to take part in the study, according to study sponsor, the Bill and Melinda Gates Medical Research Institute (Gates MRI).

The M72 study will be conducted at 60 different sites in South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam. The researchers estimate that between 50% and 60% of the study participants will be in South Africa.

"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," said Dr Lee Fairlie, Director of Maternal and Child Health at Wits RHI at Wits and co-national principal investigator for the trial in South Africa.

"South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high-quality data essential for regulatory approvals."

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