We are proud to announce the completion of enrolment in the Phase 3 clinical trial evaluating MTBVAC in 7,120 newborns in sub-Saharan Africa – an important milestone in the development of a new vaccine against tuberculosis (TB).

TB remains one of the world’s deadliest infectious diseases, causing an estimated 10.8 million new cases and 1.25 million deaths each year. MTBVAC is a promising new TB vaccine candidate and the only live attenuated vaccine derived from a Mycobacterium tuberculosis isolate currently in clinical development. TBVI has supported the development of MTBVAC for more than a decade, and today´s announcement represents an important milestone in bringing this promising vaccine to licensure. The Phase 3 study is designed to assess whether MTBVAC can provide improved protection against TB disease in newborns compared to the century old BCG, the current standard vaccine given to infants in many countries with a high TB burden.

The trial is part of the wider MTBVAC programme, supported by Biofabri, the European Union (EU), and European & Developing Countries Clinical Trials Partnership (EDCTP), which aims to advance MTBVAC towards potential future use as a new vaccine to help protect people of all ages against TB.

The completion of enrolment brings MTBVAC one important step closer to addressing a crucial challenge: better protection of a new generation of newborns against tuberculosis.