Setshaba responds to South Africa’s inclusion in the Gates-led clinical trial of new a TB vaccine


Setshaba is pleased that the Gates MRI has approved funding for the long-awaited new TB trial, the Gates MRI TB M72 trial. This is a significant step towards combating the global tuberculosis crisis. With over 1.5 million deaths and 10 million new cases reported each year, the importance of developing an effective vaccine cannot be overstated. The commitment of the Gates Foundation to support this trial not only gives hope to millions of people affected by tuberculosis but also emphasises the importance of collaborative efforts in eradicating this deadly disease. As scientists, we can pave the way for a future in which tuberculosis is no longer a threat to public health by investing in innovative research and development.


This historic initiative serves as a reminder that we can make progress when we prioritise scientific advancements and collaborate towards a common goal. Setshaba is proud to have participated in the previous multi-country, epidemiologic study to assess the interferon gamma release assay (IGRA) positivity (which signifies latent TB), in populations with a high TB disease burden, such as South Africa. This study was conducted to assess the proportion of IGRA positivity, by site, and to build capacity to conduct this pivotal Phase 3 TB vaccine efficacy study. Setshaba was one of nine sites selected to conduct this study (Gates MRI) in South Africa that led to this upcoming phase 3 trial, and we wholeheartedly support the Gates Foundation’s mission to improve global health outcomes. We saw firsthand the potential of groundbreaking research and development as a result of our involvement in the epidemiologic study.

Recruitment and enrollment were very successful, with Setshaba completing their enrollment of 160 participants within two months. The findings were encouraging, demonstrating that with the right resources and dedication, we can defeat even the most formidable diseases. The findings for this epi study have not yet been published, and we look forward to seeing the potential impact of this groundbreaking vaccine trial on tuberculosis prevention and control around the world.

Setshaba has been selected to participate in the resultant Phase 3 trial, Gates M72, and we anticipate it to start early 2024. This will be an anchor study for us in the coming year.