The workplan is divided into five Work Packages and one work package for post-project activities. This last work package is not part of this EDCTP-project. Activities under WP4 and 5 will continue as well after the EDCTP-project.
WP1 Capacity building and training in Quantiferon and whole blood assays
The University of Cape Town (UCT) leads this work package. This work package ensures the readiness to carry out immunogenicity evaluation of MTBVAC in the six different sites in three different geographical regions in sub-Saharan Africa (Senegal, Madagascar and South Africa).
WP2 Safety and Immunogenicity studies
Stellenbosch University (SUN) will lead this work package. The aim of this work package is to conduct a safety and immunogenicity evaluation of the selected dose-formulation of MTBVAC in a larger cohort from the Phase2a studies before moving to efficacy evaluation.
WP3 Pivotal Safety & Efficacy until first interim analysis
The University of Cape Town (UCT) will lead this work package. The objective of this work package is to carry out the evaluation until first interim analysis.
WP4 Immunogenicity evaluation of samples from WP2, WP3
This work package will be led by University of Cape Town (UCT) and is dedicated to conduct the immunogenicity evaluation of the processed samples taken in work packages 1 and 2.
WP5 Project management
Led by Biofabri, this work package is dedicated to the project management and governance of the project.
Next steps following the MTBVACN3 project
The Data Safety Monitoring Board (DSMB) will safety review and advice to progress to Safety & Efficacy Stage until end of study. During this phase the conduction of a pivotal safety, immunogenicity and efficacy study from first interim analysis to second interim analyses and end of study will be continued.