Project: MTBVAC in Newborns: Phase 2a Dose-Defining Safety and Immunogenicity Study and Capacity Building to Support Vaccine Efficacy Trials in Tuberculosis-Endemic Regions of Sub-Saharan Africa

Acronym	MTBVAC-Newborns (Reference Number: RIA2016V-1637)
Duration	01/01/2018 - 31/12/2020
Project Topic	A new effective tuberculosis (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 and as such, live attenuated mycobacterial vaccines may offer better protection to this naïve population compared to adults. MTBVAC is a novel TB vaccine candidate based on an attenuated M. tuberculosis clinical isolate. Safety and immunogenicity of MTBVAC was demonstrated in BCG naïve adults; and MTBVAC appears safe in a Phase 1b study in South African newborns. Definitive demonstration of safety and immunogenicity at the optimal MTBVAC dose is key to progression into multi-centre efficacy trials in infants. EDCTP supports this Phase 2a dose-defining study of MTBVAC to evaluate the safety, reactogenicity, immunogenicity, and potential for IGRA conversion and reversion, of MTBVAC in South African newborns. The first 12 months of this clinical development the consortium members were focussed on the preparations of the infant efficacy trial of MTBVAC by establishing a network of three African sites in South Africa, Senegal and Madagascar. The trial is planned to start in February 2019 at the SATVI site in South Africa.   In parallel with the preparation activities for the clinical trial capacity building activities were also initiated at the sites in Senegal and Madagascar. These activities included immunology laboratory technology transfer and training activities provided by SATVI. This with the aim to collect crucial TB epidemiological data to enable swift transition into a Phase 3 infant trial, pending favourable data from this project. Further information can be found on the project website: https://www.tbvi.eu/for-partners/mtbvac-in-newborns-2/mtbvac-in-newborns/.
Network	EDCTP2
Call	Vaccines for poverty-related diseases (PRDs)

Project partner

Number	Name	Role	Country
1	Biofabri S.L.	Coordinator	Spain
2	Centre de Recherche Biomédicale Espoir Pour La Santé	Partner	Senegal
3	Institut Pasteur de Madagascar	Partner	Madagascar
4	Stichting tuBerculosis Vaccine Initiative	Partner	Netherlands
5	Universidad de Zaragoza	Partner	Spain
6	University of Cape Town	Partner	South Africa