Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials

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  • Mena Lora A.J.
    • Other Affiliation: University of Illinois at Chicago
  • Long J.E.
    • Other Affiliation: University of Washington
  • Huang Y.
    • Other Affiliation: Fred Hutchinson Cancer Center
  • Baden L.R.
    • Other Affiliation: Brigham and Women's Hospital
  • El Sahly H.M.
    • Other Affiliation: Baylor College of Medicine
  • Follmann D.
    • Other Affiliation: National Institutes of Health
  • Goepfert P.
    • Other Affiliation: University of Alabama at Birmingham
  • Gray G.
    • Other Affiliation: University of the Witwatersrand
  • Grinsztejn B.
    • Other Affiliation: National Institute of Infectious Diseases-Fundação Oswaldo Cruz
  • Kotloff K.
    • Other Affiliation: University of Maryland School of Medicine
  • Rouphael N.
    • Other Affiliation: Emory University School of Medicine
  • Sobieszczyk M.
    • Other Affiliation: Columbia University Irving Medical Center
  • Walsh S.R.
    • Other Affiliation: Brigham and Women's Hospital
  • Andriesen J.
    • Other Affiliation: Fred Hutchinson Cancer Center
  • Shah K.A.
    • Other Affiliation: Fred Hutchinson Cancer Research Center
  • Zhang Y.
    • Other Affiliation: Fred Hutchinson Cancer Research Center
  • Gilbert P.
    • Other Affiliation: University of Washington
  • Janes H.
    • Other Affiliation: Fred Hutchinson Cancer Research Center
  • Gay C.L.
    • Affiliation: School of Medicine, Division of Infectious Diseases
  • Falsey A.R.
    • Other Affiliation: University of Rochester
  • Tripp R.L.
    • Other Affiliation: Fred Hutchinson Cancer Center
  • Gorman R.L.
    • Other Affiliation: Biomedical Advanced Research & Development Authority
  • Tong T.
    • Other Affiliation: National Institutes of Health
  • Marovich M.
    • Other Affiliation: National Institutes of Health
  • Neuzil K.
    • Other Affiliation: University of Maryland, Baltimore
  • Corey L.
    • Other Affiliation: University of Washington
  • Kublin J.G.
    • Other Affiliation: University of Washington
Abstract
  • Importance: The COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts. Observations: To support the rapid development of vaccines for the US population and the rest of the world, the National Institute of Allergy and Infectious Diseases established the COVID-19 Prevention Network (CoVPN) to assist in the coordination and implementation of phase 3 efficacy trials for COVID-19 vaccine candidates and monoclonal antibodies. By bringing together multiple networks, CoVPN was able to draw on existing clinical and laboratory infrastructure, community partnerships, and research expertise to quickly pivot clinical trial sites to conduct COVID-19 vaccine trials as soon as the investigational products were ready for phase 3 testing. The mission of CoVPN was to operationalize phase 3 vaccine trials using harmonized protocols, laboratory assays, and a single data and safety monitoring board to oversee the various studies. These trials, while staggered in time of initiation, overlapped in time and course of conduct and ultimately led to the successful completion of multiple studies and US Food and Drug Administration-licensed or -authorized vaccines, the first of which was available to the public less than 1 year from the discovery of the virus. Conclusions and Relevance: This Special Communication describes the design, geographic distribution, and underlying principles of conduct of these efficacy trials and summarizes data from 136 382 prospectively followed-up participants, including more than 2500 with documented COVID-19. These successful efforts can be replicated for other important research initiatives and point to the importance of investments in clinical trial infrastructure integral to pandemic preparedness.
Date of publication
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DOI
Identifier
Resource type
  • Article
Journal title
  • JAMA network open
Journal volume
  • 6
Journal issue
  • 1
Page start
  • e2251974
Language
  • English
Version
  • Postprint
ISSN
  • 2574-3805

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