BARDA has announced its first award through the Rapid Response Partnership Vehicle. The $25.5 million award to Allucent supports decentralized clinical trial (DCT) solutions and enables better vaccine correlates of protection (CoP) data collection from larger and more diverse populations.

This effort is being funded under Project NextGen, a $5 billion program led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers.

Using DCTs to reduce barriers to participation has the potential to increase the breadth and diversity of participants in clinical trials and improve accessibility for at-risk populations and those with rare diseases or mobility challenges. Decentralizing clinical trials will allow some or all trial-related activities to take place at trial participants’ homes instead of having to visit research sites. These activities include self-sample collection; use of a wearable device to monitor pulse rate, temperature, oxygenation; and use of an electronic diary for reporting symptoms and capturing sample shipment information.

The study, PROJECT REimagining Measurements and Operations of Translational Endpoints (REMOTE), is designed to assess the potential vaccine CoP using antibody data correlated to symptomatic COVID-19 following vaccination with a U.S. Food and Drug Administration (FDA) licensed COVID-19 vaccine. Participants will be randomized into two groups: those visiting the clinic for venous blood collection, and those self-collecting capillary blood specimens at home.

This Project Award to Allucent is part of the Project NextGen Enablers program, which aims to advance technologies that decrease costs, speed production, increase efficacy, and improve accessibility to aid a faster response to emerging infectious diseases. This includes accelerating DCT solutions and enabling better vaccine CoP data collection that can help further understanding of CoPs specific to and across different populations.

The work under this agreement contributes to the goals set in the BARDA 2022-2026 Strategic Plan, which highlights the importance of ensuring the nation’s response posture accounts for the needs of all segments of the population, and that participants are included from an appropriate balance of diverse backgrounds into clinical studies and/or trials that BARDA funds.

This award is one component of BARDA’s Project NextGen medical countermeasures portfolio. Visit the Project NextGen portfolio page to learn more.

Learn how to become a consortium member: https://www.rrpv.org/how-to-join/