NIH forms COVID-19 clinical trials network

By Samantha Black, PhD, The Science Advisory Board editor in chief

July 8, 2020 -- The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), has established a new clinical trials network to conduct large-scale testing of COVID-19 vaccines and monoclonal antibodies.

The network, named the COVID-19 Prevention Trials Network (COVPN), merges four existing NIAID-funded clinical trial networks:

  • HIV Vaccine Trials Network, based in Seattle
  • HIV Prevention Trials Network, based in Durham, NC
  • Infectious Diseases Clinical Research Consortium, based in Atlanta
  • AIDS Clinical Trials Group, based in Los Angeles

These groups will continue their work with HIV but will now also perform new roles for COVID-19 clinical trials.

The network has been established as part of President Trump's Operation Warp Speed, which aims to deliver substantial quantities of a safe, effective vaccine by January 2021, according to U.S. Department of Health and Human Services Secretary Alex Azar. Through the new centralized network, thousands of volunteers will be enrolled in large-scale clinical trials needed to develop COVID-19 therapeutics and vaccines.

COVPN will use a harmonized vaccine protocol developed by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership which will enable cross-analysis across multiple vaccine trials. The network is expected to operate more than 100 clinical trial sites across the U.S. and internationally.

With a focus on community engagement, each phase III clinical trial that COVPN conducts will require thousands of volunteers, including those from vulnerable communities. People can learn more about vaccine and monoclonal antibody studies and the network on the COVPN website.

The website contains a data collection platform to securely identify potential trial participants. People who are interested can sign up for a rolling clinical trial participant registry, which contains security-enhanced protections. Subsequently, clinical study staff will use the registry to contact and screen potential volunteers.

The first phase III clinical trial that COVPN will conduct is for the messenger RNA (mRNA)-1273 vaccine, developed jointly between NIAID and Moderna. The study is expected to begin this summer.

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