Allucent Will Conduct New
Decentralized Phase IV Study Aimed
at
Counteracting Future Coronavirus Strains and
Variants
CARY,
N.C., May 15, 2024 /PRNewswire/
-- Allucent, a global mid-sized clinical research organization
(CRO), announced today that it received a project award valued at
$25.5 million through the Rapid
Response Partnership Vehicle (RRPV) Consortium to conduct its
Decentralized Home Focus COVID-19 Trial. The RRPV is a
consortium funded by the Biomedical Advanced Research and
Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response (ASPR) in the U.S. Department
of Health and Human Services (HHS). Funding for this award was
received under Project NextGen, an initiative by HHS to advance
vaccines, therapeutics, and enabling technologies to improve
preparedness for COVID-19 now and in the future.
As SARS-CoV-2, the virus that caused the COVID-19
pandemic, continues to evolve, it is imperative to establish
vaccine correlates of protection (CoPs) against the disease,
particularly in a geographically diverse population that can have a
broad range of immunologic responses to both the disease and
vaccines. To address this need, Allucent will leverage its
expertise in decentralized clinical trials (DCTs) to
conduct this study, enabling participation across more locations
and decreasing the burdens participants may encounter while
taking part in a trial. The information collected during the trial
will be leveraged to assess CoPs using humoral immunogenicity data
correlated to symptomatic COVID-19 infections.
"We are proud to apply our decentralized trial
expertise as a partner to BARDA on this initiative," said
Mark A. Goldberg, M.D., chairman and
chief executive officer of Allucent. "The continuing emergence of
new variants and subvariants underscores the need for ongoing
optimization of COVID-19 vaccines to ensure their effectiveness in
combating the virus. This study is a step forward in addressing the
evolving challenges posed by COVID-19 and mitigating their
impact on public health."
Under the project award, Allucent will initiate and conduct a
4,000-participant decentralized Phase IV observational
study to assess CoPs following vaccination with a U.S. Food and
Drug Administration (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. Applying a
multi-faceted 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.
This project has been funded in whole or in part 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 on a mission to help bring new therapies to
light by solving the distinct challenges of its biopharma and
government clients. Allucent is a global provider of comprehensive
drug development solutions, including consulting, clinical
operations, biometrics, and clinical pharmacology across various
therapeutic areas. With more than 30 years of experience in
over 60 countries, Allucent's individualized partnership
approach provides experience-driven insights and expertise to
assist its clients in successfully navigating the complexities of
delivering novel treatments to patients.
Visit Allucent.com for more information.
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SOURCE Allucent