In a significant advancement for global tuberculosis prevention, IAVI and Biofabri/Zendal have initiated the IMAGINE clinical trial, administering the first doses of their promising TB vaccine candidate MTBVAC. The trial launched on February 19, 2025, at Be Part Research in Paarl, South Africa, marking a crucial step forward in the fight against tuberculosis, which claimed 1.25 million lives in 2023.
Trial Design and Scope
The IMAGINE trial (Investigation of MTBVAC toward Accelerating Global Immunization for a Neglected Epidemic) will evaluate MTBVAC's safety and efficacy in preventing active TB lung disease. This Phase 2b study aims to enroll approximately 4,300 participants with latent TB infection across 15 clinical sites in South Africa, Kenya, and Tanzania. Participants will receive a single intradermal dose and be monitored for two to three years to assess the vaccine's efficacy.
"A new and efficacious vaccine against TB, the world's deadliest infectious disease, would have tremendous public health impact," stated Dr. Mark Feinberg, IAVI President and CEO. "This trial represents a very important milestone in global efforts to mitigate the terrible impact of the TB pandemic."
Scientific Innovation
MTBVAC represents a significant scientific advancement in TB vaccine development. Unlike the currently approved Bacillus Calmette-Guérin (BCG) vaccine, which is derived from Mycobacterium bovis and offers only partial protection to children, MTBVAC is the only live-attenuated vaccine candidate derived directly from Mycobacterium tuberculosis in current trials.
The vaccine was designed by Carlos Martin from the University of Zaragoza and Brigitte Gicquel from Institut Pasteur, with industrial development by Biofabri. Previous Phase 2 trials in adults and neonates have shown promising results, with immunogenicity and safety profiles comparable or favorable to BCG.
Public Health Impact
Professor Keertan Dheda, principal investigator for the IMAGINE trial, emphasized the urgent need for an effective TB vaccine: "TB is historically the biggest killer of mankind, resulting in 11 million newly diseased individuals every year. Drug-resistant TB is an emerging threat that is difficult and more expensive to treat."
The trial's success could have far-reaching implications for global health. As a single-shot vaccine, MTBVAC could potentially prevent millions of TB cases, particularly in hard-to-reach populations. Biofabri and IAVI have committed to ensuring affordable access in low- and middle-income countries if the vaccine proves effective.
Global Collaboration
The IMAGINE trial represents a collaborative effort between multiple international partners, including research institutions across three African countries. The study is funded by Open Philanthropy, the Gates Foundation, and the German Federal Ministry of Education and Research through the KfW Development Bank.
"This effort has been made possible by a global collaboration between IAVI, our Spanish partners Biofabri and the University of Zaragoza, and our trial site partners in South Africa, Kenya, and Tanzania," said Ana Céspedes, COO of IAVI. "We are working towards the same common goal: the end of the devastating impacts of TB disease."
