From 10-12 May 2022, a kick-off meeting for the MTBVAC phase III clinical trial was held in Baiona, Spain. With the only licensed vaccine against TB, Bacillus Calmette Guerin (BCG), having limited impact on transmission of Mycobacterium tuberculosis, there is an urgent need for a new and improved TB vaccine. MTBVAC is a live attenuated M. tuberculosis vaccine, which is currently entering a randomised, double-blind, active BCG-controlled phase III clinical trial. This study evaluates the safety and efficacy of MTBVAC administered by intradermal route in 7120 healthy, BCG-naïve, HIV-uninfected newborns born to HIV-uninfected mothers and HIV-infected mothers without known exposure to close/household TB contacts.
For three days, members of the MTBVACN3 consortium had the opportunity to get to know each other and discuss the details of this study. During the first session, the design of this project was outlined, including an update on the work done so far and a description of the trial endpoints and safety considerations. This general overview provided the frame to further discuss the protocol parameters on the second day, including the statistical design, procedures, timelines, and logistics involving vaccine distribution and sample management. Participants also shared their previous expertise in risk management and community engagement to create the respective plans and ensure the success of this study.