Randomised, Double-Blind, Controlled Phase 3 Trial to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Healthy HIV Unexposed and HIV Exposed Uninfected Newborns in Tuberculosis-Endemic Regions of Sub-Saharan Africa

What this Trial Is About

Researchers are evaluating the safety, immune response, and improved effectiveness of a new live tuberculosis vaccine called MTBVAC in a Phase 3 trial involving HIV-uninfected infants born to both HIV-infected and uninfected mothers. This study compares MTBVAC to the standard BCG vaccine in regions of sub-Saharan Africa with high TB rates. The project builds on partnerships between European and African institutions and aims to enhance laboratory capacity for TB vaccine studies and sample storage to better understand protection mechanisms. The trial involves two groups: one receiving the MTBVAC vaccine and the other receiving the standard BCG vaccine. Both vaccines are given as a single 0.05 mL dose by injection into the left upper arm within seven days of birth. MTBVAC is a genetically modified vaccine designed to include more tuberculosis antigens than BCG. The vaccines are stored and administered under strict conditions and the optimal MTBVAC dose will be selected based on earlier phase studies. Participants will be followed for a minimum of 24 months up to a maximum of 80 months, with regular monitoring for signs of tuberculosis disease and vaccine safety. Researchers will assess the vaccine's ability to prevent TB and record any side effects. The study includes medical evaluations, access to maternal and infant health records, and collection of immunological data to better understand how the vaccine works. The total participation period covers several years to fully evaluate long-term safety and effectiveness.

Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa