The project “MTBVACN3” aims to perform a Randomised, Double-blind Controlled Phase 3 Trial to evaluate the efficacy, safety and immunogenicity of MTBVAC-vaccine administered in healthy HIV unexposed uninfected, and HIV exposed uninfected newborns in Tuberculosis-endemic regions of Sub-Saharan Africa.
A new effective TB vaccine is essential to achieve World Health Organization End TB goals and eliminate TB by 2050. The optimal long-term strategy would be a combination of serial mass campaigns in adults, coupled with universal newborn vaccination. Newborns are the only human population without prior mycobacterial exposure in TB endemic countries. This project is based on the hypothesis that live attenuated mycobacterial vaccines will offer better protection to this naïve population compared to adults.
The objective of this project is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M.tuberculosis vaccine called MTBVAC in a Phase 3 efficacy trial in HIV-uninfected infants born to HIV-infected and HIV-uninfected mothers as compared to standard of care BCG vaccination.
The EDCTP (European & Development Countries Clinical Trials Partnership) and Biofabri are supporting this clinical trial. The project is part of the EDCTP2 programme supported by the EU.