Active Infection & Immunity Cancer

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

In plain English

AI plain-English summary

A tuberculosis vaccine candidate is about to be tested in a large-scale trial in Africa, and this grant ensures that blood samples from every participant are collected, shipped, and stored for a decade so scientists can later figure out *why* it works. TB kills more people than any other single infectious disease, yet no vaccine reliably prevents it in adults and adolescents. The leading candidate, BCG, protects infants but offers inconsistent protection in older age groups. This trial tests a new vaccine, MTBVAC, in people who already carry a latent TB infection—the very group most at risk of developing active, contagious disease. If the vaccine proves effective, the stored blood specimens will allow researchers to identify the specific immune responses that correlate with protection. That knowledge is currently missing. Identifying a correlate of protection would transform TB vaccine development. Instead of running decade-long, multi-thousand-person efficacy trials for every new candidate, researchers could use a simple blood test to quickly screen which vaccines are most promising. This would dramatically accelerate the pipeline for a vaccine that could prevent millions of deaths. The grant itself does not test the vaccine—it builds the infrastructure to learn from the trial, whatever its outcome.

View original technical description
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.

View the original record at the funder ↗

Researchers

Lewis Schrager (EPMC Awardee)

Related Research

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Transfer of a non-human primate (NHP) in vitro functional assay for the early evaluation of TB vaccine candidates and the associated immune response
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Original classification

Discretionary Award

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