Allucent Wins BARDA Award for COVID-19 Vaccine Decentralized Trial

CARY, N.C., May 15, 2024 – Allucent, a global clinical research organization, has secured a $25.5 million project award through the Rapid Response Partnership Vehicle (RRPV) Consortium to execute its Decentralized Home Focus COVID-19 Trial. Funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) under the U.S. Department of Health and Human Services (HHS), this initiative is aligned with Project NextGen. The goal of Project NextGen is to enhance vaccines, therapeutics, and technology to improve COVID-19 preparedness.

With the constant evolution of SARS-CoV-2, the virus responsible for COVID-19, it is critical to identify vaccine correlates of protection (CoPs) in a diverse population with varied immune responses. To meet this need, Allucent will utilize its proficiency in decentralized clinical trials (DCTs), enabling participation from a wider geographical area and reducing the burden on participants. The trial's data collection will focus on evaluating CoPs through humoral immunogenicity data linked to symptomatic COVID-19 cases.

Mark A. Goldberg, M.D., chairman and CEO of Allucent, stated, "We are honored to employ our decentralized trial expertise in collaboration with BARDA on this project. The appearance of new variants and subvariants continues to highlight the necessity for the ongoing refinement of COVID-19 vaccines to maintain their efficacy. This study represents progress in addressing the dynamic challenges of COVID-19 and diminishing their effect on public health."

Under the awarded project, Allucent will conduct a decentralized Phase IV observational study involving 4,000 participants to evaluate CoPs post-vaccination with an FDA-approved or authorized COVID-19 vaccine. The study will utilize Allucent's bespoke decentralized trial model to simplify and enhance the participant experience. By employing a comprehensive strategy, Allucent will assess the feasibility of remote, self-collected specimens for CoP analysis and incorporate wearable devices to potentially predict COVID-19 infections. The data obtained will be used to generate valuable insights for the ongoing battle against COVID-19.

This project is entirely or partially funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under Other Transaction (OT) number 75A50123D00005/75A50123F61002.

About Allucent

Allucent is dedicated to helping bring new therapies to light by addressing the unique challenges of its biopharma and government clients. As a global provider of comprehensive drug development solutions, Allucent offers consulting, clinical operations, biometrics, and clinical pharmacology services across various therapeutic areas. With over 30 years of experience in more than 60 countries, Allucent's personalized partnership approach delivers experience-based insights and expertise to help its clients successfully navigate the complexities of bringing innovative treatments to patients.

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