The Aurum Institute welcomes the recent announcement by Wellcome and the Bill & Melinda Gates Foundation to advance a tuberculosis (TB) vaccine candidate, M72/AS01E (M72), through a Phase III clinical trial.
“We welcome this funding commitment by Bill & Melinda Gates Foundation (BMGF) and Wellcome because it will help build new capacity and sustain existing capacity within the country, strengthen the research infrastructure and potentially accelerate future vaccine development efforts, including for pandemic preparedness,” - Aurum Managing Director: Clinical Research Division, Tanya Nielson.
In South Africa, TB remains one of the leading causes of death. The Bacillus Calmette-Guérin (BCG) vaccine, which was developed more than a 100 years ago, is currently the only available vaccine against TB. The BCG vaccine offers limited and variable protection, particularly in adults and adolescents.
If successful, Nielson says the advanced vaccine could significantly reduce the TB burden globally. It offers hope for a more effective TB prevention tool that could save millions of lives, especially for the most vulnerable people in low-resource settings.
“This announcement is a remarkable endeavor that represents hope, dedication, and the unwavering pursuit of a better future for those affected by TB.” said Nielson.
With this funding, four Aurum Clinical Research Sites will be contributing 500-1000 participants each towards the 26,000 total participants required for the trial. In this contribution, Aurum Clinical Director: Clinical Research Division, Dr Craig Innes said the sites will be responsible for recruiting volunteers, screening them to see if they are eligible to enroll, then vaccinating them and following them up for side effects and to see if they get TB during the trial.
The Aurum sites are looking to start enrolling participants, 15-45 years of age, with no current or previous TB, who can be HIV negative or positive and relatively healthy, come November.
Innes added that prior to this announcement, Aurum Klerksdorp and Tembisa Sites were two of the sites selected to conduct TB-018 trial (2014-2018) which tested the M72 vaccine in HIV-negative participants.
The Klerksdorp site was also selected to test the M72 vaccine in HIV-positive participants in the MESA-TB trial (2020-2022).
The clinical trials journey is a long and challenging one, according to Innes, however he finds it a profound privilege to be part of the M72 vaccine clinical trial process for nearly a decade.
1.6 million people died from #Tuberculosis (TB) in 2021.
— Wellcome (@wellcometrust) June 28, 2023
Progress to fight TB has been slow, with few scientific breakthroughs and unequal access to treatments.
A new clinical trial, funded by Wellcome and @gatesfoundation, could help change that ⤵️https://t.co/ks0xbwi0WJ
