MTBVAC-AVANTE

Tuberculosis (TB), as the leading infectious disease killer in the world, disproportionately affects low- and middle-income countries, particularly in the Africa and Southeast Asia regions. Currently, there are over 10.8 million new cases and 1.25 million deaths annually due to TB. Despite advances in treatment, the disease burden persists, exacerbated by drug resistance and high co-infection rates with HIV. MTBVAC, a novel and highly promising TB vaccine candidate, is the only live attenuated derivative of a Mycobacterium tuberculosis (M.tb) isolate in clinical development. The goal of the MTBVAC-AVANTE consortium is to advance MTBVAC through Phase 2b development in adolescents and adults and through Phase 3 development in infants, while generating key data to support licensure and widespread deployment in those countries most impacted by TB. The consortium aims to achieve this goal through the conduct of two late-stage trial, that will generate clinical evidence of MTBVAC’s efficacy in preventing pulmonary TB, and of its safety and immunogenicity in adolescents and adults living in TB-endemic countries in sub-Saharan Africa. Moreover, we will demonstrate MTBVAC’s improved efficacy compared to BCG in preventing TB disease in neonates born to HIV-infected and -uninfected mothers. We will also ensure the timely translation of findings into public health practice and policy, by defining regulatory pathways to accelerate widespread availability for the use of MTBVAC in adolescents and adults and as a BCG alternative in neonates; and ensure generated evidence contributes to widespread adoption in SSA and beyond, in consultation with communities and regional and local authorities. The consortium brings together a diverse group of European and African partners, including two non-for-profit product development partnerships with extensive TB vaccine development expertise (IAVI and TBVI), Biofabri, Universidad de Zaragoza and experienced Clinical Research Centers in SSA.