Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials
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Published:2023-01-23
Issue:1
Volume:6
Page:e2251974
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ISSN:2574-3805
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Container-title:JAMA Network Open
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language:en
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Short-container-title:JAMA Netw Open
Author:
Mena Lora Alfredo J.1, Long Jessica E.2, Huang Yunda34, Baden Lindsey R.5, El Sahly Hana M.67, Follmann Dean8, Goepfert Paul9, Gray Glenda1011, Grinsztejn Beatriz12, Kotloff Karen13, Rouphael Nadine14, Sobieszczyk Magdelena15, Walsh Stephen R.5, Andriesen Jessica3, Shah Karan A.4, Zhang Yuanyuan4, Gilbert Peter16, Janes Holly317, Gay Cynthia L.18, Falsey Ann R.19, Tripp Rebecca L.3, Gorman Richard L.20, Tong Tina21, Marovich Mary21, Neuzil Kathleen22, Corey Lawrence323, Kublin James G.324, Reirden Daniel25, Immergluck Lilly25, Kelley Colleen25, Durbin Anna25, Tapia Milagritos25, Deming Megan25, Kotloff Karen25, Pinto Jorge25, Goepfert Paul25, Hoosain Zaheer25, Lombaard Johan25, Stephenson Kathryn25, Baden Lindsey25, Walsh Stephen25, Mayer Ken25, Cahn Pedro25, Losso Marcelo25, Cassetti Isabel25, Innes Steven25, Bekker Linda-Gail25, Kassim Sheetal25, Orrel Catherine25, Meintjes Graeme25, Ward Amy25, Diacon Andreas25, Wohl David25, Gray Cindy25, Turley Chrinstine25, Oyedele Temitope25, Taiwo Babafemi O.25, Krueger Karen25, Novak Rick25, Sha Beverly E.25, Hammit Laura25, Fichtenbaum Carl25, Bernstein David25, Jacobson Jeffrey25, Dandachi Dima25, Naqvi Hasan25, Koletar Susan25, Rouphael Nadine25, Edupuganti Sri25, Campbell Thomas25, Secord Elizabeth25, Siva Samantha25, Jeenarain Nitesha25, Naidoo Logashvari25, Garrett Nigel25, Naicker Nivashnee25, Naicker Vimla25, Naidoo Jayganthie25, Premrajh Anamikah25, Walter Emmanuel25, Henderson Jeff25, Tempelman Hugo25, Siika Abraham25, Anderson Evan25, Okech Brenda25, Rupp Richard25, El Sahly Hana25, Healy Catherine M.25, Arduino Robert25, Winokur Patricia25, Casapia Martin25, Marshall Gailen25, Navalkele Bhagyashri D.25, Badel-Faeson Sharla25, Sanne Ian25, Fairlie Lee25, Kekitiinwa Adeodata25, Ntege Patricia25, Elyanu Peter J.25, Mutuluuza Cissy K.25, Rwambuya Sandra25, Musoke Philippa25, Wabwire Deo25, Pahud Barbara25, Castro Mario25, Sawe Fredrick25, Ouma Samuel G.25, Samandari Taraz25, Mboya Grace25, Innes Craig25, Kotze Philip25, Lama Javier25, Sanchez Jorge25, Gallardo Jorge25, Gonzales Pedro25, Cabello Robinson25, Landovitz Raphael25, Dube Michael P.25, Gould-Porter Tamela25, Shoptaw Steve25, Clark Jesse25, Kotze Sheena25, Kasselman Olivia25, Gill Katherine25, Nchabeleng Maphoshane25, Gaur Aditya25, Cabrera Carlos25, Doblecki-Lewis Susanne25, Kline Susan25, McClelland Scott25, Kishorchandra Mandaliya25, Mda Pamela25, Dubula Thozama25, Jaoko Walter25, Kalams Spyros25, Haas David25, Berthaud Vladimir25, Creech Clarence25, Abdalian Sue Ellen25, Justman Jessica25, Delafontaine 25, Marks Kristen25, Mannheimer Sharon25, Van Tieu Hong25, Sobieszczyk Magda25, Mulligan Mark25, Raabe Vanessa25, Olson Mary25, Erb Juanita25, Swaminathan Shobha25, Pilotto Jose25, Hall Christopher25, Florescu Diana25, de Jesus Edwin25, Frank Ian25, Barr Katie25, McMahon Deborah25, Riddler Sharon25, Martin Judith M.25, Barranco Elizabeth25, Santos Breno25, Tashima Karen25, Grinsztejn Beatriz25, Filho Esau J.25, Keefer Mike25, Falsey Ann25, Brumskine William25, Cohen Stuart25, Okulicz Jason25, Taylor Barbara25, Patterson Thomas25, Maves Ryan25, Little Susan25, Buchbinder Susan25, Luetkemeyer Annie25, Zorrilla Carmen25, Kallas Esper25, Silva Vivian A.25, Newman Tamara25, Valdez Madruga Jose25, McElrath Julie25, Jackson Lisa25, Wald Anna25, Malahleha Mookho25, Laher Fatima25, Lazarus Erica25, Nana Anusha25, Hoft Daniel25, Frey Sharon25, Presti Rachel25, Nachman Sharon25, Luft Benjamin25, Rodriguez Carina25, Mngadi Kathy25, Daar Eric25, Barnabas Shaun25, Cotton Mark25, Spector Stephen25, Servilla Karen25, Linder Kathleen A.25, Moana Abeer25, Kauffman Carol25, Bessesen Mary25, Talwani Rohit25, Dell'Italia Louis25, Alonto Augusto25, Liebman Daniel25, Bedimo Roger25, Woods Christopher25, Sriram Peruvemba25, Padala Kalpana25, Holt Gregory25, Swialto Edwin25, Jay Melanie25, Felson Sabrina25, Henderson Nora25, Brown Sheldon25, Aguayo Saumuel25, Riddle Mark25, Tien Phyllis25, Toney John25, Dawood Halima25, Makhaza Disebo25, Mighty Hugh25, Mahgoub Siham25, Campbell Wes25, Diemert David25, Schwasinger-Schmidt Tiffany25, Morse Caryn G.25, Sanders John W.25, Williamson John25, Luabeya Angelique25, Bukusi Elizabeth25, Mugo Nelly25, Kibuuka Hannah25, Mwesigwe Betty25, Kambugu Andrew25, Balyegisawa Apolo P.25, Mullane Kathleen25, Andagalu Ben25, Tina Lucas25, Copeland Nathaniel25, Hutter Jack25, de las Casas Claudio L.25, Ruiz-Palacios Guillermo25, Eron Joseph J.25, Currier Judith S.25, Cohen Myron S.25, Kim Kami25, Greenberg Richard N.25, Kasaro Margaret25, Delaney-Moretlwe Sinead25, Dawson Rodney25, Paez Carmen25, Grunenberg Nicole25, Hahn William O.25, Gelderbloom Huub C.25, Andrasik Michele P.25, Wallace Stephaun E.25,
Affiliation:
1. Division of Infectious Diseases, Department of Medicine, University of Illinois at Chicago 2. Department of Medicine, University of Washington, Seattle 3. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington 4. Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington 5. Division of Infectious Diseases, Brigham and Women’s Hospital, Boston, Massachusetts 6. Infectious Diseases Section, Department of Medicine, Baylor College of Medicine, Houston, Texas 7. Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas 8. Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 9. Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham 10. Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 11. South African Medical Research Council, Cape Town, South Africa 12. HIV/STI Clinical Research Laboratory, Evandro Chagas National Institute of Infectious Diseases–Fundação Oswaldo Cruz, Rio de Janeiro, Brazil 13. Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, and the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore 14. Hope Clinic of the Emory Vaccine Center, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Decatur, Georgia 15. Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York, New York 16. Department of Biostatistics, University of Washington, Seattle 17. Bioinformatics and Epidemiology Program, Fred Hutchinson Cancer Research Center, Seattle, Washington 18. Division of Infectious Diseases, Department of Medicine, UNC HIV Cure Center, University of North Carolina at Chapel Hill School of Medicine 19. Infectious Disease Division, Department of Medicine, University of Rochester, Rochester, New York 20. Division of Clinical Development, Biomedical Advanced Research & Development Authority, Washington, DC 21. Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, Maryland 22. Department of Medicine, University of Maryland, Baltimore 23. Department of Laboratory Medicine and Pathology, University of Washington, Seattle 24. Department of Global Health, University of Washington, Seattle 25. for the COVID-19 Prevention Network
Abstract
ImportanceThe 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.ObservationsTo 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 RelevanceThis 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.
Publisher
American Medical Association (AMA)
Cited by
19 articles.
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