May 1, 2024
The Clinical HIV Research Unit (CHRU) announced the start of the Bill & Melinda Gates Medical Research Institute’s (Gates MRI) large Phase 3 clinical trial to assess the efficacy of the M72/AS01E TB vaccine candidate at its refurbished Isango Lethemba TB Research Unit in the Eastern Cape. The Eastern Cape has the highest TB incidence in the country.
Dr Alemnew Dagnew, clinical lead of the M72 program, explained, “If shown to be well-tolerated and effective, this TB vaccine candidate could become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new vaccine to prevent TB in over 100 years.”
Gates MRI expects to recruit around 20,000 study participants aged 15 to 44 across up to 60 trial sites across seven countries - South Africa, Kenya, Zambia, Malawi, Mozambique, Vietnam and Indonesia.
Professor Ian Sanne, divisional head of CHRU said, “Thank you to the Bill & Melinda Gates Medical Research Institute for ensuring that South Africa is part of this important trial. TB remains the number one killer disease in South Africa and the Eastern Cape bears the highest TB incidence. The Isango Lethemba TB Research Unit will play a central role in the study while strengthening the research capacity in the Eastern Cape.”
Acting Deputy Director General for HIV, AIDS & STIs in the Department of Health, Ramphelane Morewane, said, “I am optimistic that the Gates MRI-sponsored candidate TB vaccine trial will support our goal to reduce the TB burden in the region. We need a TB vaccine to protect adolescents and adults.”
Public health facilities will be involved in participant recruitment. Healthcare workers and individuals who have had recent close contact with someone with TB are more likely to have latent TB infection and will be approached to participate in the trial.
Dr Asanda Poswa, the Isango Lethemba TB Research Unit’s Principal Investigator for the study, explained, “TB is a complex disease which can lie dormant in the body. If the infection progresses to active TB, a person becomes ill with TB and can transmit it to others. In most cases, this presents as pulmonary TB, impacting the lungs. This candidate TB vaccine aims to prevent that progression, helping to stop the spread of TB. A novel TB vaccine with an acceptable safety profile for adolescents and adults is critical to the vision of a world without TB.”
“Evidence generated from the site’s research has contributed to innovation in the treatment of drug-resistant TB, such as a shorter treatment regimen,” said Sanne. “We have recently expanded our research portfolio to evaluate shorter regimens for drug-susceptible TB, and now the M72/AS01E TB vaccine candidate.”
Funding support for the trial comes from the Bill & Melinda Gates Foundation and Wellcome. GSK provides technical assistance to the Gates MRI and supplies the adjuvant component of the vaccine for the phase 3 trial.
The refurbished Isango Lethemba TB Research Unit has been serving the Eastern Cape in collaboration with the Eastern Cape Department of Health since 2018.
Adults and children aged between 15 and 44 and in good physical health, are being recruited to join the trial. Contact +27 69 990 1886 to find out more.