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

作者：Alfredo J Mena Lora, Jessica E. Long, Yunda Huang, Lindsey R. Baden, Hana M. El Sahly, Dean Follmann, Paul Goepfert, Glenda Gray, Beatriz Grinsztejn, Karen L. Kotloff, Nadine Rouphael, Magdelena Sobieszczyk, Stephen R. Walsh, Jessica Andriesen, Karan A. Shah, Yuanyuan Zhang, Peter B. Gilbert, Holly Janes, Cynthia L. Gay, Ann R. Falsey, Rebecca L. Tripp, Richard L. Gorman, Tina Tong, Mary Marovich, Kathleen M. Neuzil, Lawrence Corey, James G. Kublin, COVID-19 Prevention Network, Daniel Reirden, Lilly Cheng Immergluck, Colleen F. Kelley, Anna P. Durbin, Milagritos Tapia, Megan Deming, Karen L. Kotloff, Jorge Pinto, Paul Goepfert, Zaheer Hoosain, Johan Lombaard, Kathryn E. Stephenson, Lindsey R. Baden, Stephen R. Walsh, Ken Mayer, Pedro Cahn, Marcelo Losso, Isabel Cassetti, Steven Innes, Linda‐Gail Bekker, Sheetal Kassim, Catherine Orrel, Graeme Meintjes, Amy Ward, Andreas Diacon, David A. Wohl, Cindy M. Gray, Chrinstine Turley, Temitope Oyedele, Babafemi Taiwo, Karen Krueger, Rick Novak, Beverly E. Sha, Laura Hammit, Carl J. Fichtenbaum, David I. Bernstein, Jeffrey M. Jacobson, Dima Dandachi, Hasan Raja Naqvi, Susan L. Koletar, Nadine Rouphael, Sri Edupuganti, Thomas Campbell, Elizabeth Secord, Samantha Siva, Nitesha Jeenarain, Logashvari Naidoo, Nigel Garrett, Nivashnee Naicker, Vimla Naicker, Jayganthie Naidoo, Anamikah Premrajh, Emmanuel B. Walter, Jeff Henderson, Hugo A. Tempelman, Abraham Siika, Evan J. Anderson, Brenda Okech, Richard Rupp, Hana M. El Sahly, Catherine M. Healy, Robert Arduino, Patricia Winokur, Martín Casapía, Gailen D. Marshall, Bhagyashri Navalkele, Sharla Badel-Faeson, Ian Sanne, Lee Fairlie, Adeodata Kekitiinwa, Patricia Ntege, Peter Elyanu, Cissy K. Mutuluuza, Sandra Rwambuya, Philippa Musoke, Deo Wabwire, Barbara Pahud, Mario Castro, Fredrick Sawe, Samuel Gurrion Ouma, Taraz Samandari, Grace Mboya, Craig Innes, Philip Kotze, Javier R. Lama, Jorge Sanchez, Jorge Gallardo, Pedro Gonzáles, Robinson Cabello, Raphael J. Landovitz, Michael P. Dubé, Tamela Gould-Porter, Steven Shoptaw, Jesse N. Clark, Sheena Kotze, Olivia Kasselman, Katherine Gill, Maphoshane Nchabeleng, Aditya H. Gaur, Carlos Cabrera, Susanne Doblecki‐Lewis, Susan Kline, Scott McClelland, Mandaliya Kishorchandra, Pamela Mda, Thozama Dubula, Walter Jaoko, Spyros A. Kalams, David M. Haas, Vladimir Berthaud, C. Buddy Creech, Sue Ellen Abdalian, Jessica Justman, Delafontaine, Kristen Marks, Sharon Mannheimer, Hong‐Van Tieu, Magda Sobieszczyk, Mark J. Mulligan, Vanessa Raabe, Mary C. Olson, Juanita Erb, Shobha Swaminathan, José Henrique Pilotto, Christopher J. Hall, Diana F. Florescu, Edwin de Jesus, Ian Frank, Katie Barr, Deborah K. McMahon, Sharon A. Riddler, Judith M. Martin, Elizabeth Barranco, Breno Santos, Karen T. Tashima, Beatriz Grinsztejn, Esau J. Filho, Mike Keefer, Ann R. Falsey, William Brumskine, Stuart H. Cohen, Jason F. Okulicz, Barbara S. Taylor, Thomas L. Patterson, Ryan C. Maves, Susan J. Little, Susan Buchbinder, Annie Luetkemeyer, Carmen Zorrilla, Esper G. Kallás, Vivian A. Silva, Tâmara Newman, José Valdez Madruga, Julie McElrath, Lisa A. Jackson, Anna Wald, Mookho Malahleha, Fatima Laher, Erica Lazarus, Anusha Nana, Daniel F. Hoft, Sharon E. Frey, Rachel M. Presti, Sharon Nachman, Benjamin J. Luft, Carina A. Rodriguez, Kathy Mngadi, Eric S. Daar, Shaun Barnabas, Mark F. Cotton, Stephen A. Spector, Karen S. Servilla, Kathleen A. Linder, Abeer Moana, Carol A. Kauffman, Mary Bessesen, Rohit Talwani, Louis J. Dell’Italia, Augusto Alonto, Daniel L. Liebman, Roger Bedimo, Christopher W. Woods, Peruvemba Sriram, Kalpana P. Padala, Gregory Holt, Edwin Swialto, Melanie Jay, Sabrina Felson, Nora Henderson, Sheldon T. Brown, Saumuel Aguayo, Mark S. Riddle, Phyllis C. Tien, John Toney, Halima Dawood, Disebo Makhaza, Hugh Mighty, Siham Mahgoub, Wesley C. Campbell, David Diemert, Tiffany Schwasinger‐Schmidt, Caryn G. Morse, John W. Sanders, John Williamson, Angelique Kany Kany Luabeya, Elizabeth A. Bukusi, Nelly Mugo, Hannah Kibuuka, Betty Mwesigwe, Andrew Kambugu, Apolo Balyegisawa, Kathleen M. Mullane, Ben Andagalu, Lucas Otieno Tina, Nathaniel Copeland, Jack Hutter, Claudio L. de las Casas, Guillermo M. Ruiz‐Palacios, Joseph Eron, Judith S. Currier, Myron S. Cohen, Kami Kim, Richard N. Greenberg, Margaret P. Kasaro, Sinead Delaney-Moretlwe, Rodney Dawson, Carmen A. Paez, Nicole Grunenberg, William O. Hahn, Huub C. Gelderbloom, Michele P. Andrasik, Stephaun E. Wallace · 发表于：JAMA Network Open · 年份：2023 · DOI：10.1001/jamanetworkopen.2022.51974 · 被引用次数：38 · 研究领域：SARS-CoV-2 and COVID-19 Research、vaccines and immunoinformatics approaches、SARS-CoV-2 detection and testing

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 an...