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

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 th...

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Published in:JAMA network open Vol. 6; no. 1; p. e2251974
Main Authors: Mena Lora, Alfredo J, Long, Jessica E, Huang, Yunda, Baden, Lindsey R, El Sahly, Hana M, Follmann, Dean, Goepfert, Paul, Gray, Glenda, Grinsztejn, Beatriz, Kotloff, Karen, Rouphael, Nadine, Sobieszczyk, Magdelena, Walsh, Stephen R, Andriesen, Jessica, Shah, Karan A, Zhang, Yuanyuan, Gilbert, Peter, Janes, Holly, Gay, Cynthia L, Falsey, Ann R, Tripp, Rebecca L, Gorman, Richard L, Tong, Tina, Marovich, Mary, Neuzil, Kathleen, Corey, Lawrence, Kublin, James G
Format: Journal Article
Language:English
Published: United States American Medical Association 03-01-2023
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Summary: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. 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. 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.
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Concept and design: Mena Lora, Long, Huang, Baden, El Sahly, Follman, Goepfert, Kotloff, Rouphael, Sobieszczyk, Walsh, Shah, Gilbert, Tripp, Gorman, Neuzil, Corey, Kublin.
Critical revision of the manuscript for important intellectual content: Mena Lora, Long, Huang, Baden, El Sahly, Follman, Gray, Grinsztejn, Rouphael, Sobieszczyk, Walsh, Andriesen, Gilbert, Janes, Gay, Tripp, Gorman, Tong, Marovich, Neuzil, Corey, Kublin.
Statistical analysis: Huang, Follman, Andriesen, Shah, Zhang, Gilbert.
Obtained funding: Huang, Baden, El Sahly, Kotloff, Gilbert, Gorman, Neuzil, Kublin.
Drafting of the manuscript: Mena Lora, Long, Goepfert, Kotloff, Shah, Zhang, Falsey, Tripp, Gorman, Kublin.
Supervision: Huang, Baden, Walsh, Gilbert, Janes, Tripp, Gorman, Tong, Marovich, Neuzil, Corey, Kublin.
Author Contributions: Mr Kublin had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Mena Lora and Long contributed equally to this work.
Acquisition, analysis, or interpretation of data: Long, Huang, Baden, El Sahly, Gray, Grinsztejn, Kotloff, Rouphael, Sobieszczyk, Walsh, Andriesen, Shah, Zhang, Gilbert, Janes, Gay, Falsey, Tong, Marovich, Neuzil, Kublin.
Administrative, technical, or material support: Mena Lora, Long, Huang, Baden, Goepfert, Gray, Grinsztejn, Kotloff, Rouphael, Sobieszczyk, Walsh, Shah, Gilbert, Tripp, Gorman, Tong, Marovich, Kublin.
ISSN:2574-3805
2574-3805
DOI:10.1001/jamanetworkopen.2022.51974