File:MTBCAC CDPath.pdf

English: Figure 3. MTBVAC from discovery to human clinical evaluation abiding by Pasteur’s principles on vaccine development. Identification of virulence genes phoP and of PDIM locus in M. tuberculosis (1997-2001) settled the basis for MTBVAC construction (2005-2008). 2001 until present: ongoing preclinical characterization studies deciphering mechanisms of vaccine safety and induced protection in different recognized TB-relevant animal models conducted by different national and international laboratories: mouse studies (Unizar) and other laboratories in Spain), guinea pigs (Public Health England (PHE)) and non-human primates (PHE and Biomedical Primate Research Center (BPRC) 2008-2012: GMP development of freeze-dried MTBVAC. 2012 until present: Industrial development and scale-up production of MTBVAC. 2012: First-in-human Phase 1a clinical evaluation of MTBVAC in healthy adults in Lausanne, Switzerland (funded by TBVI). 2015: successful Phase 1a completion leads to first-in-human Phase 1b evaluation of MTBVAC in newborns in South Africa in collaboration with the South African Tuberculosis Vaccine Initiative (SATVI) (NORAD funding). 2019: MTBVAC enters two dose-defining Phase 2 trials in South Africa, one in adults (in collaboration with IAVI, US) and another one in newborns (EDCTP2-funded), which includes capacity building studies in Senegal and Madagascar. 2021: MTBVAC received EDCTP funding for a Phase 3 efficacy evaluation in newborns in South Africa, Senegal and Madagascar. BIOFABRI is the exclusive licensee of MTBVAC and industrial developer and Sponsor of MTBVAC clinical trials. University of Zaragoza (Unizar) is MTBVAC intellectual rights owner and vaccine discoverer, and TBVI is the European Tuberculosis Vaccine Initiative and IAVI is the International AIDS Vaccine Initiative. Since 2008, BIOFABRI works in close collaboration with Unizar and TBVI in the GMP and clinical development of MTBVAC. In 2020, IAVI collaborations were initiated.