MTBVACN3 advances phase 3 tuberculosis vaccine trial and strengthens African research capacity
The MTBVACN3 project is advancing the phase 3 clinical development of MTBVAC, a novel tuberculosis (TB) vaccine candidate for newborns in sub-Saharan Africa. The project aims to position MTBVAC as a potential replacement for BCG, which provides only partial protection against pulmonary TB.
The phase 3 randomised, double-blind trial is evaluating the efficacy, safety and immunogenicity of MTBVAC compared with BCG in healthy, HIV-unexposed and HIV-exposed uninfected newborns in tuberculosis-endemic regions across sites in South Africa, Senegal and Madagascar. The study plans to enrol 7,120 newborns, including a 7,000-participant efficacy cohort in South Africa.
During the consortium’s 4th Annual Meeting, held in Durban, South Africa, from 21–23 April 2026, partners reviewed progress achieved following completion of the period supported under EDCTP2 funding. Recruitment remains ahead of target, with 6,086 newborns randomised by December 2025 (approximately 85% of the target enrolment), and no major safety concerns identified by the independent Data Safety Monitoring Board (DSMB). The meeting also provided an opportunity to address operational and scientific challenges and to agree on mitigation strategies to support study timelines and the successful completion of the trial in 2028.
Throughout the project, consortium partners have actively disseminated progress through major international TB vaccine and global health forums, while maintaining engagement with regulators, WHO stakeholders, policymakers and community representatives to maximise global accessibility and uptake of the findings.
The project has also strengthened clinical and laboratory capacity across six African research centres through training, technology transfer and certification in advanced immunological assays and sample processing techniques. In parallel, the consortium has progressed preparations for potential licensure and implementation, including manufacturing, regulatory and market access planning to support equitable vaccine availability in high-TB-burden countries.
Overall, MTBVACN3 continues to make strong progress toward generating the efficacy data required to support future licensure and global implementation of MTBVACN3, while reinforcing African clinical research capacity and long-term preparedness for future vaccine trials.