As the COVID-19 pandemic evolves, characterization of correlates of protection (CoPs) are critical for ongoing vaccine development and optimization as variants and subvariants continue to emerge. As part of Project NextGen, BARDA intends to leverage immunogenicity data from multiple clinical trials of investigational next-generation COVID-19 vaccines and FDA licensed or authorized COVID-19 vaccines to inform a broader understanding of immunologic correlates of vaccine protection. In addition to interventional clinical trials of investigational products, establishing a paradigm that allows for the capture of real-world data on both immunologic and clinical endpoints is critical for a continual assessment of thresholds of protection in an immunologically heterogeneous and geographically diverse cross-section of the United States.
PROJECT REimagining Measurements and Operations of Translational Endpoints (REMOTE)
Project Details
Member Organization: Allucent
Award Date: 05/14/2024
Award Amount: $25,514,420
Project Duration: 42 Months
Solicitation Number: RRPV RPP-24-02-HomeFocus
Project Objective: Allucent will initiate and conduct a 4,000-participant decentralized Phase IV observational study to assess CoPs following vaccination with an FDA-approved or authorized COVID-19 vaccine. The study will employ Allucent’s customized decentralized trial delivery model to simplify and streamline participants’ trial experience. By applying a multi-faceted, state-of-the-art approach, Allucent will assess the feasibility of remote, self-collected specimens for CoP analysis and integrate wearable devices to potentially forecast COVID-19 infections. The data will be used to generate actionable insights to support the ongoing fight against COVID-19.
