Condition: Tuberculosis · Sponsor: Biofabri, S.L
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 proposal builds upon a group of TB vaccine development partners in Europe and sub-Saharan Africa established in a previous EDCTP-supported project. It creates an expanded consortium of clinical trial partners for the optimal implementation of a large infant efficacy trial of MTBVAC in high TB incidence settings. New capacity for efficacy trials in infants will be a valuable resource for the TB vaccine development community. The proposal will create a network of institutions in three TB endemic African countries with enhanced laboratory capacity to conduct TB vaccine immunology studies and to bio-bank samples to discover immune correlates of vaccine-mediated protection.
This description comes directly from the study's public registry record.
Ingrid Murillo Jelsbak · +34 986 33 04 00 · ingrid.murillo@biofabri.es
Andrea García Silva · +34 986 33 04 00 · a.garciasilva@biofabri.es
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| South African Tuberculosis Initiative, Brewelskloof Hospital | Worcester, Western Cape, South Africa | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04975178