NIH kicks off COVID-19 vaccine, monoclonal antibody research network

Regulatory NewsRegulatory News | 08 July 2020 |  By 

The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19.
The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.
“Starting this summer, this new network will leverage existing infrastructure and engage communities to secure the thousands of volunteers needed for late-stage clinical trials of promising vaccines,” said Health and Human Services Secretary Alex Azar.
The network, dubbed the COVID-19 Prevention Trials Network (COVPN), is a functional unit of Operation Warp Speed, the federal partnership focused on speeding the development and delivery of COVID-19 diagnostics, therapeutics and vaccines.
Vaccine testing is to be led by Larry Corey, MD, of Fred Hutchinson Cancer Research Center (Seattle), and Kathleen Neuzil, MD, MPH of the University of Maryland (College Park). The vaccine arm of COVPN will use a harmonized protocol that permits cross-trial analysis, with more than 100 US and international trial sites being planned.
Moderna’s mRNA-1273 vaccine, which was developed jointly with NIAID, is expected to be tested in the first phase 3 clinical trial conducted through COVPN, with a start date expected this summer.
Monoclonal antibody testing will be another COVPN focus; this arm will be led by Myron Cohen, MD, of the University of North Carolina (Chapel Hill) and Emory (Atlanta) University’s David Stevens, MD.
The COVPN website features a secure, bespoke data collection platform that allows individuals to enroll in a rolling clinical trial participant registry from which potential study participants can be contacted and screened for study participation.
The hub of operations will be at Fred Hutchinson Cancer Research Center, where staff will oversee a community engagement framework designed to achieve quick recruitment of large numbers of research volunteers.
“Each of the Phase 3 clinical trials that the COVPN will conduct will require thousands of volunteers,” said NIH Director Francis Collins, MD. “Community engagement, particularly with the communities most vulnerable to COVID-19’s severe outcomes, will be critical to the success of this research endeavor.” 
“Having a safe and effective medical countermeasure to prevent COVID-19 would enable us to not only save lives but also help end the global pandemic,” said NIAID Director Anthony S. Fauci, M.D. “Centralizing our clinical research efforts into a single trials network will expand the resources and expertise needed to efficiently identify safe and effective vaccines and other prevention strategies against COVID-19.”


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Tags: coronavirus, NIH, US

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