A phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate got underway this week in South Africa.

Africa Health Research Institute’s executive director, Professor Willem Hanekom, is the co-national principal investigator for the trial in South Africa – together with Professor Lee Fairlie from the Wits RHI.

AHRI aims to enroll 1,000 participants over the next year, targeting multiple areas in northern KwaZulu-Natal where our research shows there is a high rate of new TB infections.

M72 could be a gamechanger for TB control globally: if the trial shows the vaccine is well-tolerated and effective, it would be the first vaccine to help prevent TB in adolescents and adults, and the first new TB vaccine in over 100 years.

A study commissioned by WHO estimates that over 25 years, a vaccine with 50% efficacy in preventing pulmonary TB could save 8.5 million lives, prevent 76 million new TB cases and save $41.5 billion for TB-affected households.

The trial will ultimately enrol up to 20,000 participants at around 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the researchers will know who receives a vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.

The Gates MRI, a nonprofit organisation and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial, which is supported by funding from the Gates Foundation and Wellcome.

“This is critical work: it is clear from modelling studies that if we do not have an effective vaccine that prevents TB in adolescents and adults – as BCG does in babies – we will not control the TB epidemic,” said Prof Hanekom.

Read more about the launch of the M72 trial here.

Top photo: Medication being prepared at AHRI. Photo by Patrick Shepherd / Wellcome Trust