NIH: New Network Aims to Enroll Thousands for COVID-19 Vaccine, Therapeutics Trials

The National Institute of Allergy and Infectious Diseases (NIAID) has established the COVID-19 Prevention Trials Network (COVPN) to test a variety of investigational vaccines and monoclonal antibodies against coronavirus disease 2019 (COVID-19).

The COVPN is part of “Operation Warp Speed”, a partnership led by the Department of Health and Human Services (HHS) to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Four existing NIAID-funded clinical trial networks were combined to establish the COVPN: the HIV Vaccine Trials Network (HVTN) based in Seattle; the HIV Prevention Trials Network (HPTN) based in Durham, NC; the Infectious Diseases Clinical Research Consortium (IDCRC) based in Atlanta; and the AIDS Clinical Trials Group based in Los Angeles. 

“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 HHS Secretary Alex Azar.

Vaccine testing will be led by Larry Corey, MD, of the Fred Hutchinson Cancer Research Center in Seattle, and Kathleen M. Neuzil, MD, MPH, of the University of Maryland School of Medicine, while monoclonal antibody clinical testing efforts will be led by Myron S. Cohen, MD, of the University of North Carolina, Chapel Hill, and David S. Stephens, MD, of Emory University in Atlanta. The network is expected to include over 100 clinical trial sites across the US and internationally.

A phase 3 clinical trial evaluating the investigational mRNA-1273 vaccine (Moderna) will be the first study to be conducted by the COVPN and is expected to begin this summer; the trial is looking to enroll approximately 30,000 participants. The primary end point of the study will be the prevention of symptomatic COVID-19; key secondary end points include prevention of severe COVID-19 and prevention of infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Early results from a phase 1 study led by the NIAID showed dose dependent increases in immunogenicity with the vaccine candidate. Moreover, seroconversion was observed across the 3 tested dose levels after a single dose.

“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, MD. “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.”

Individuals interested in participating in current or future COVID-19 clinical trials can register on the COVPN website. 

For more information visit nih.gov.