Washington, DC–The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a new clinical trials network that aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19.
The COVID-19 Prevention Trials Network (COVPN) was established by merging four existing NIAID-funded clinical trials networks: the HIV Vaccine Trials Network (HVTN), based in Seattle; the HIV Prevention Trials Network (HPTN), based in Durham, N.C.; the Infectious Diseases Clinical Research Consortium (IDCRC), based in Atlanta; and the AIDS Clinical Trials Group, based in Los Angeles. Those individual networks will continue to perform clinical trials for HIV vaccine and prevention and other infectious diseases in addition to their new COVID roles.
The network’s vaccine testing will be led by Larry Corey, M.D., of the Fred Hutchinson Cancer Research Center in Seattle, and Kathleen M. Neuzil, M.D., M.P.H., of the University of Maryland School of Medicine. The network’s monoclonal antibody clinical testing efforts will be led by Myron S. Cohen, M.D., of the University of North Carolina, Chapel Hill, and David S. Stephens, M.D., of Emory University in Atlanta. The HVTN, which is based at the Fred Hutchinson Cancer Research Center, will serve as the COVPN’s operational center.
The COVPN is a functional unit of “Operation Warp Speed,” a partnership led by the U.S. Department of Health and Human Services (HHS) to invest in and coordinate the development, manufacturing and distribution of COVID-19 diagnostics, therapeutics and vaccines. The network will use a harmonized vaccine protocol developed by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. This will enable analyses of correlates of protection across multiple vaccine trials. The network is expected to operate more than 100 clinical trial sites across the United States and internationally.
The network has developed an extensive community engagement framework to reach out to potential research volunteers and explain the specific details involved in participating in a vaccine or monoclonal antibody clinical study.
The first Phase 3 clinical trial that the COVPN is expected to conduct will involve testing the investigational mRNA-1273 vaccine, developed by NIAID scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. That study is expected to begin this summer.