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New Clinical Trials Network Aims to Enroll Thousands in COVID-19 Vaccine and Monoclonal Antibody Research

Strategic Insights

— 2 min read

The National Institutes of Health (NIH) has established a new clinical trials network, the COVID-19 Prevention Trials Network (COVPN), to conduct large-scale clinical trials testing investigational vaccines and monoclonal antibodies against COVID-19. The network was formed by merging four existing NIAID-funded clinical trials networks and aims to enroll thousands of volunteers in Phase 3 clinical trials. The COVPN is a key element of President Trump's Operation Warp Speed, which aims to deliver a safe and effective vaccine by January 2021.

Key Takeaways:

  • The COVPN is a unified clinical trials network established by merging four existing NIAID-funded networks: the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS Clinical Trials Group.
  • The network will conduct large-scale clinical trials testing investigational vaccines and monoclonal antibodies against COVID-19, with the aim of enrolling thousands of volunteers in Phase 3 clinical trials.
  • The COVPN is 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, for vaccine testing, and Myron S. Cohen, M.D., of the University of North Carolina, Chapel Hill, and David S. Stephens, M.D., of Emory University in Atlanta, for monoclonal antibody testing.
  • The network will use a harmonized vaccine protocol developed by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, enabling analyses of correlates of protection across multiple vaccine trials.
  • The network has developed an extensive community engagement framework to reach out to potential research volunteers and explain the details involved in participating in a vaccine or monoclonal antibody clinical study.
  • The COVPN website features a customized data collection platform, which Oracle built and donated, to securely identify potential trial participants, and interested individuals can sign up for a rolling clinical trial participant registry on the website.

Statistics:

  • The COVPN is expected to operate more than 100 clinical trial sites across the United States and internationally.
  • Each Phase 3 clinical trial will require thousands of volunteers.
  • The COVPN's vaccine testing will be led by a team of experts, including Larry Corey, M.D., and Kathleen M. Neuzil, M.D., M.P.H.
  • The network will use a harmonized vaccine protocol, developed by the ACTIV public-private partnership.
  • The COVPN website has a customized data collection platform, built and donated by Oracle.

Sources:

  • U.S. Department of Health and Human Services' National Institutes of Health
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • COVID-19 Prevention Trials Network (COVPN)
  • National Institutes of Health (NIH)
  • Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership
  • Oracle (Redwood Shores, CA)

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