A vaccine for tuberculosis in development for two decades has reached the final stage of clinical research, raising hope the world will see the first shot against the disease in a century. The first doses in the Phase III clinical trial for the M72/AS01E tuberculosis shot are being distributed in South Africa, the Bill and Melinda Gates Medical Research Institute said today. A nonprofit subsidiary of the Bill & Melinda Gates Foundation, Gates MRI sponsored the trial, which was funded by $550 million from the Gates Foundation and Wellcome, a U.K.-based philanthropy. Why it matters: The shot could help prevent pulmonary tuberculosis, the most common form of the disease, in teens and adults. More than 3,500 people died every day of tuberculosis in 2022, according to the World Health Organization, mostly in low- and middle-income countries. In South Africa, around 280,000 people are diagnosed with TB each year. People at highest risk are often living in poverty. In a Phase II trial of the vaccine conducted by GSK, the drugmaker that developed the shot, the vaccine provided approximately 50 percent protection against active pulmonary tuberculosis for three years in people infected with the tuberculosis bacteria who were HIV-negative. The result is unprecedented in decades of TB vaccine research, according to Gates MRI. “Reaching Phase III 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 Reproductive Health and HIV Institute at the University of the Witwatersrand, Johannesburg, who is leading the trial there. What’s next? The trial is expected to include up to 20,000 participants, including people living with HIV, at up to 60 sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. The trial is expected to last up to five years.
|