MTBVACN3 Annual Investigators meeting

The 3rd annual meeting of the MTBVACN3 project took place on 26-28 May 2025 in Baiona, near Biofabri headquarters, in Spain. MTBVAC is one of the promising tuberculosis (TB) vaccine candidates for newborns. The target is to vaccinate 7,120 newborns against tuberculosis during their first week of life.

During the meeting, consortium partners from nine participating organisations—including UCT-SAVI, SUN-FAMCRU, Wits VIDA, ECF, IPM, CRB-EPLS, TBVI, University of Zaragoza, and Biofabri—shared their experiences and reviewed the progress of the study. Presentations highlighted the current recruitment status and various challenges encountered thus far, particularly focusing on data management and participant retention. Strategies to enhance participant engagement and retention were extensively discussed, especially in consideration of cultural practices that may lead to early withdrawals. There was a notable emphasis on the need to bolster community engagement to foster a better understanding and adherence to the vaccination treatment.

To date, the team has recruited 60% of the target sample (n=7,120 infants), who have been vaccinated across the six recruiting centres. The MTBVACN3 study is a phase 3 trial aiming to evaluate the efficacy, safety, and immunogenicity of the vaccine administered in healthy HIV-unexposed and HIV-exposed uninfected Newborns in tuberculosis (TB)-endemic regions of sub-Saharan Africa, including Madagascar, Senegal, and South Africa.

Dr Montserrat Blázquez-Domingo, Senior Project Officer, attended the meeting in person, represented the EDCTP Association. She presented an overview of the evolution of the three EDCTP programmes, emphasised the requirements in final reporting, and stressed the legal requirement for open-access publications supported by EDCTP, as well as the early appointment of independent auditors prior to project completion.