Support for Correlates of Protection efforts associated with the C113 phase 2b trial of MTBVAC in IGRA+, HIV- African adults and adolescents

IAVI will be conducting a phase 2b trial assessing MTBVAC efficacy in preventing TB in 4,300 Interferon Gamma Release Assay (IGRA)+, HIV- African adults and adolescents (the C113 trial). Safety and immunogenicity of MTBVAC will be assessed as secondary objectives. It will be essential to collect and store blood specimens to permit assessments of correlates of immune protection (CoP) should the vaccine prove efficacious. The identification of one or more immune correlates of protection against developing TB disease would represent a major breakthrough, hastening the development of future TB vaccines. This grant will support the collection, shipping, and storage of specimens for CoP analysis during the trial and will fund the biorepository, where the specimens will be stored for 10 years and made available for future CoP analyses.