In December 2023 IAVI and Biofabri, a subsidiary of Zendal, announced that IAVI has been awarded US$55 million by the Bill & Melinda Gates Foundation to conduct a Phase IIb trial assessing the safety and efficacy of MTBVAC. MTBVAC is a tuberculosis (TB) vaccine candidate for the prevention of active TB lung disease in adolescents and adults. Thanks to an Open Philanthropy grant and additional funding from the German Federal Ministry of Education and Research (BMBF) the trial is expected to begin enrolling participants in mid 2024.
A historic opportunity secures funds
Dr Mark Feinberg, president and CEO of IAVI, is “thrilled to have secured the investment” that the team needs to advance the “promising vaccine candidate into an efficacy study”.
“The world urgently needs a new, effective vaccine that can prevent TB disease in adults and adolescents, and we are hopeful that MTBVAC will be part of the solution to finally end the TB epidemic.”
Dr Feinberg thanked the Bill & Melinda Gate Foundation for “their support”, also recognising Open Philanthropy, whose “visionary investment” could “accelerate the availability of MTBVAC by several years” if it proves safe and efficacious in trial. Dr Lewis Schrager is senior leader of TB vaccine development efforts at IAVI, describing this progress as an “historic opportunity”.
“If MTBVAC were shown to safely prevent TB disease in this population, this vaccine could prove to be critically important in global strategies to suppress the TB pandemic given its ease of use, low cost, and anticipated widespread availability.”
Dr Kundai Chinyenze, IAVI Africa director, is “gratified” to begin work on the trial in a region “where TB is a leading contributor to morbidity and mortality”, particularlly for people who are living with HIV.
“IAVI’s long history in conducting clinical trials in Africa and our strong network of regional and global partners provide a solid foundation for the successful conduct of this important trial.”
MTBVAC
The vaccine is being developed for two purposes: as a more effective and potentially longer-lasting vaccine for newborns, and for the prevention of TB disease in adults and adolescents. Previous Phase Ib/IIa dose-ranging studies in adults and neonates demonstrated “favourable immunogenicity and safety profiles”.
Designed by Dr Carlos Martín Montañés and Dr Brigitte Gicquel, MTBVAC was in-licensed by Biofabri. It is a live attenuated vaccine derived from Mycobacterium tuberculosis, the bacterium that causes TB disease in humans. It is the only live attenuated vaccine from this bacterium in the pipeline, and, with this derivation from the human TB-causing organism rather than the bovine, MTBVAC “has the potential to generate a broad protective immune response. Administrated via intradermal delivery, it does not require an adjuvant.
The study of MTBVAC to prevent TB disease is expected to enrol around 4,300 people who have latent TB infection in South Africa and “select other sub-Saharan African countries in areas with high TB burden”. They will be between the ages of 14 and 45. Over 15-20 trial sites the participants will receive a single dose of MTBVAC or placebo, with observation lasting two or three years.
Esteban Rodriguez, CEO of Biofabri, is “delighted by the fantastic opportunity” to evaluate the vaccine.
“The outcome of the efficacy studies in neonates as well as those in adolescents and adults will provide us with a pathway to license MTBVAC for all age groups.”
If the trial shows MTBVAC to be safe and efficacious, Biofabri, IAVI, and other collaborators emphasise their intention to “ensure” it is manufactured and supplied in “sufficient quantities globally” and is “accessible at affordable prices in low- and middle-income countries”.
Could this be the turning point in tackling TB? For more on exciting progress with vaccine development don’t forget to subscribe to our weekly newsletters here.
