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

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dc.contributor.authorMena Lora, Alfredo J.
dc.contributor.authorLong, Jessica E.
dc.contributor.authorHuang, Yunda
dc.contributor.authorBaden, Lindsey R.
dc.contributor.authorEl Sahly, Hana M.
dc.contributor.authorFollmann, Dean
dc.contributor.authorGoepfert, Paul
dc.contributor.authorGray, Glenda
dc.contributor.authorGrinsztejn, Beatriz
dc.contributor.authorKotloff, Karen
dc.contributor.authorRouphael, Nadine
dc.contributor.authorSobieszczyk, Magdelena
dc.contributor.authorWalsh, Stephen R.
dc.contributor.authorAndriesen, Jessica
dc.contributor.authorShah, Karan A.
dc.contributor.authorZhang, Yuanyuan
dc.contributor.authorGilbert, Peter
dc.contributor.authorJanes, Holly
dc.contributor.authorGay, Cynthia L.
dc.contributor.authorFalsey, Ann R.
dc.contributor.authorTripp, Rebecca L.
dc.contributor.authorGorman, Richard L.
dc.contributor.authorTong, Tina
dc.contributor.authorMarovich, Mary
dc.contributor.authorNeuzil, Kathleen
dc.contributor.authorCorey, Lawrence
dc.contributor.authorKublin, James G.
dc.date.accessioned2024-05-20T17:44:31Z
dc.date.available2024-05-20T17:44:31Z
dc.date.issued2023-01
dc.description.abstractImportance 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.
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dc.identifier.citationMena Lora AJ, Long JE, Huang Y, et al. Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials. JAMA Netw Open. 2023;6(1):e2251974. doi:10.1001/jamanetworkopen.2022.51974
dc.identifier.otherdoi:10.1001/jamanetworkopen.2022.51974
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/966
dc.language.isoen
dc.relation.ispartofseriesJAMA Network Open; 6(1):e2251974
dc.titleRapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials
dc.typeArticle
dc.typeinfo:eurepo/semantics/article
dc.typeinfo:arrepo/semantics/artículo

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