Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials
| Autor(a) principal: | |
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| Data de Publicação: | 2023 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | por |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/57779 |
Resumo: | COVID-19 Prevention Network: Daniel Reirden, Lilly Immergluck, Colleen Kelley, Anna Durbin, Milagritos Tapia, Megan Deming, Karen Kotloff, Jorge Pinto, Paul Goepfert, Zaheer Hoosain, Johan Lombaard, Kathryn Stephenson, Lindsey Baden, Stephen 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 Wohl, Cindy Gray, Chrinstine Turley, Temitope Oyedele, Babafemi O Taiwo, Karen Krueger, Rick Novak, Beverly E Sha, Laura Hammit, Carl Fichtenbaum, David Bernstein, Jeffrey Jacobson, Dima Dandachi, Hasan Naqvi, Susan 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 Walter, Jeff Henderson, Hugo Tempelman, Abraham Siika, Evan Anderson, Brenda Okech, Richard Rupp, Hana El Sahly, Catherine M Healy, Robert Arduino, Patricia Winokur, Martin Casapia, Gailen Marshall, Bhagyashri D Navalkele, Sharla Badel-Faeson, Ian Sanne, Lee Fairlie, Adeodata Kekitiinwa, Patricia Ntege, Peter J Elyanu, Cissy K Mutuluuza, Sandra Rwambuya, Philippa Musoke, Deo Wabwire, Barbara Pahud, Mario Castro, Fredrick Sawe, Samuel G Ouma, Taraz Samandari, Grace Mboya, Craig Innes, Philip Kotze, Javier Lama, Jorge Sanchez, Jorge Gallardo, Pedro Gonzales, Robinson Cabello, Raphael Landovitz, Michael P Dube, Tamela Gould-Porter, Steve Shoptaw, Jesse Clark, Sheena Kotze, Olivia Kasselman, Katherine Gill, Maphoshane Nchabeleng, Aditya Gaur, Carlos Cabrera, Susanne Doblecki-Lewis, Susan Kline, Scott McClelland, Mandaliya Kishorchandra, Pamela Mda, Thozama Dubula, Walter Jaoko, Spyros Kalams, David Haas, Vladimir Berthaud, Clarence Creech, Sue Ellen Abdalian, Jessica Justman, Delafontaine, Kristen Marks, Sharon Mannheimer, Hong Van Tieu, Magda Sobieszczyk, Mark Mulligan, Vanessa Raabe, Mary Olson, Juanita Erb, Shobha Swaminathan, Jose Pilotto, Christopher Hall, Diana Florescu, Edwin de Jesus, Ian Frank, Katie Barr, Deborah McMahon, Sharon Riddler, Judith M Martin, Elizabeth Barranco, Breno Santos, Karen Tashima, Beatriz Grinsztejn, Esau J Filho, Mike Keefer, Ann Falsey, William Brumskine, Stuart Cohen, Jason Okulicz, Barbara Taylor, Thomas Patterson, Ryan Maves, Susan Little, Susan Buchbinder, Annie Luetkemeyer, Carmen Zorrilla, Esper Kallas, Vivian A Silva, Tamara Newman, Jose Valdez Madruga, Julie McElrath, Lisa Jackson, Anna Wald, Mookho Malahleha, Fatima Laher, Erica Lazarus, Anusha Nana, Daniel Hoft, Sharon Frey, Rachel Presti, Sharon Nachman, Benjamin Luft, Carina Rodriguez, Kathy Mngadi, Eric Daar, Shaun Barnabas, Mark Cotton, Stephen Spector, Karen Servilla, Kathleen A Linder, Abeer Moana, Carol Kauffman, Mary Bessesen, Rohit Talwani, Louis Dell'Italia, Augusto Alonto, Daniel Liebman, Roger Bedimo, Christopher Woods, Peruvemba Sriram, Kalpana Padala, Gregory Holt, Edwin Swialto, Melanie Jay, Sabrina Felson, Nora Henderson, Sheldon Brown, Saumuel Aguayo, Mark Riddle, Phyllis Tien, John Toney, Halima Dawood, Disebo Makhaza, Hugh Mighty, Siham Mahgoub, Wes Campbell, David Diemert, Tiffany Schwasinger-Schmidt, Caryn G Morse, John W Sanders, John Williamson, Angelique Luabeya, Elizabeth Bukusi, Nelly Mugo, Hannah Kibuuka, Betty Mwesigwe, Andrew Kambugu, Apolo P Balyegisawa, Kathleen Mullane, Ben Andagalu, Lucas Tina, Nathaniel Copeland, Jack Hutter, Claudio L de Las Casas, Guillermo Ruiz-Palacios, Joseph J Eron, Judith S Currier, Myron S Cohen, Kami Kim, Richard N Greenberg, Margaret Kasaro, Sinead Delaney-Moretlwe, Rodney Dawson, Carmen Paez, Nicole Grunenberg, William O Hahn, Huub C Gelderbloom, Michele P Andrasik, Stephaun E Wallace. |
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Lora, Alfredo J. MenaLong, Jessica E.Huang, YundaBaden, Lindsey R.Sahly, Hana M. ElFollmann, DeanGoepfert, PaulGray, GlendaGrinsztejn, BeatrizKotloff, KarenRouphael, NadineSobieszczyk, MagdelenaWalsh, Stephen R.Andriesen, JessicaShah, Karan A.Yuanyuan, ZhangGilbert, PeterJanes, HollyGay, Cynthia L.Falsey, Ann R.Tripp, Rebecca L.Gorman, Richard L.Tong, TinaMarovich, MaryNeuzil, KathleenCorey, LawrenceKublin, James G.2023-04-14T13:09:26Z2023-04-14T13:09:26Z2023LORA, Alfredo J. Mena et al. Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials. JAMA Network Open, v. 6, n. 1, p. 1-15, Jan. 2023.0098-7484https://www.arca.fiocruz.br/handle/icict/5777910.1001/jamanetworkopen.2022.519742574-3805COVID-19 Prevention Network: Daniel Reirden, Lilly Immergluck, Colleen Kelley, Anna Durbin, Milagritos Tapia, Megan Deming, Karen Kotloff, Jorge Pinto, Paul Goepfert, Zaheer Hoosain, Johan Lombaard, Kathryn Stephenson, Lindsey Baden, Stephen 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 Wohl, Cindy Gray, Chrinstine Turley, Temitope Oyedele, Babafemi O Taiwo, Karen Krueger, Rick Novak, Beverly E Sha, Laura Hammit, Carl Fichtenbaum, David Bernstein, Jeffrey Jacobson, Dima Dandachi, Hasan Naqvi, Susan 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 Walter, Jeff Henderson, Hugo Tempelman, Abraham Siika, Evan Anderson, Brenda Okech, Richard Rupp, Hana El Sahly, Catherine M Healy, Robert Arduino, Patricia Winokur, Martin Casapia, Gailen Marshall, Bhagyashri D Navalkele, Sharla Badel-Faeson, Ian Sanne, Lee Fairlie, Adeodata Kekitiinwa, Patricia Ntege, Peter J Elyanu, Cissy K Mutuluuza, Sandra Rwambuya, Philippa Musoke, Deo Wabwire, Barbara Pahud, Mario Castro, Fredrick Sawe, Samuel G Ouma, Taraz Samandari, Grace Mboya, Craig Innes, Philip Kotze, Javier Lama, Jorge Sanchez, Jorge Gallardo, Pedro Gonzales, Robinson Cabello, Raphael Landovitz, Michael P Dube, Tamela Gould-Porter, Steve Shoptaw, Jesse Clark, Sheena Kotze, Olivia Kasselman, Katherine Gill, Maphoshane Nchabeleng, Aditya Gaur, Carlos Cabrera, Susanne Doblecki-Lewis, Susan Kline, Scott McClelland, Mandaliya Kishorchandra, Pamela Mda, Thozama Dubula, Walter Jaoko, Spyros Kalams, David Haas, Vladimir Berthaud, Clarence Creech, Sue Ellen Abdalian, Jessica Justman, Delafontaine, Kristen Marks, Sharon Mannheimer, Hong Van Tieu, Magda Sobieszczyk, Mark Mulligan, Vanessa Raabe, Mary Olson, Juanita Erb, Shobha Swaminathan, Jose Pilotto, Christopher Hall, Diana Florescu, Edwin de Jesus, Ian Frank, Katie Barr, Deborah McMahon, Sharon Riddler, Judith M Martin, Elizabeth Barranco, Breno Santos, Karen Tashima, Beatriz Grinsztejn, Esau J Filho, Mike Keefer, Ann Falsey, William Brumskine, Stuart Cohen, Jason Okulicz, Barbara Taylor, Thomas Patterson, Ryan Maves, Susan Little, Susan Buchbinder, Annie Luetkemeyer, Carmen Zorrilla, Esper Kallas, Vivian A Silva, Tamara Newman, Jose Valdez Madruga, Julie McElrath, Lisa Jackson, Anna Wald, Mookho Malahleha, Fatima Laher, Erica Lazarus, Anusha Nana, Daniel Hoft, Sharon Frey, Rachel Presti, Sharon Nachman, Benjamin Luft, Carina Rodriguez, Kathy Mngadi, Eric Daar, Shaun Barnabas, Mark Cotton, Stephen Spector, Karen Servilla, Kathleen A Linder, Abeer Moana, Carol Kauffman, Mary Bessesen, Rohit Talwani, Louis Dell'Italia, Augusto Alonto, Daniel Liebman, Roger Bedimo, Christopher Woods, Peruvemba Sriram, Kalpana Padala, Gregory Holt, Edwin Swialto, Melanie Jay, Sabrina Felson, Nora Henderson, Sheldon Brown, Saumuel Aguayo, Mark Riddle, Phyllis Tien, John Toney, Halima Dawood, Disebo Makhaza, Hugh Mighty, Siham Mahgoub, Wes Campbell, David Diemert, Tiffany Schwasinger-Schmidt, Caryn G Morse, John W Sanders, John Williamson, Angelique Luabeya, Elizabeth Bukusi, Nelly Mugo, Hannah Kibuuka, Betty Mwesigwe, Andrew Kambugu, Apolo P Balyegisawa, Kathleen Mullane, Ben Andagalu, Lucas Tina, Nathaniel Copeland, Jack Hutter, Claudio L de Las Casas, Guillermo Ruiz-Palacios, Joseph J Eron, Judith S Currier, Myron S Cohen, Kami Kim, Richard N Greenberg, Margaret Kasaro, Sinead Delaney-Moretlwe, Rodney Dawson, Carmen Paez, Nicole Grunenberg, William O Hahn, Huub C Gelderbloom, Michele P Andrasik, Stephaun E Wallace.University of Illinois at Chicago. Division of Infectious Diseases, Department of Medicine. Chicago, USA.University of Washington, Seattle. Department of Medicine. Washington, DC, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA / Fred Hutchinson Cancer Center. Statistical Center for HIV/AIDS Research & Prevention. Washington, DC, USA.Brigham and Women's Hospital. Division of Infectious Diseases, Boston, Massachusetts, USA.Baylor College of Medicine, Houston. Infectious Diseases Section, Department of Medicine. Texas, USA / Baylor College of Medicine. Department of Molecular Virology and Microbiology. Houston, Texas, USA.National Institutes of Health. National Institute of Allergy and Infectious Diseases. Biostatistics Research Branch. Bethesda, Maryland, USA.University of Alabama at Birmingham. Division of Infectious Diseases, Department of Medicine. Alabama, USA.University of the Witwatersrand. Faculty of Health Sciences. Perinatal HIV Research Unit. Johannesburg, South Africa / South African Medical Research Council. Cape Town, South Africa.Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. HIV/STI Clinical Research Laboratory. Rio de Janeiro, RJ, Brazil.University of Maryland School of Medicine. Department of Pediatrics, and the Center for Vaccine Development. Division of Infectious Disease and Tropical Pediatrics. Baltimore, USA.Emory University School of Medicine. Department of Medicine, Division of Infectious Diseases. Decatur, Georgia, USA.Columbia University Irving Medical Center. Department of Medicine. Division of Infectious Diseases. New York, USA.Baylor College of Medicine, Houston. Infectious Diseases Section, Department of Medicine. Texas, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.Fred Hutchinson Cancer Center. Statistical Center for HIV/AIDS Research & Prevention. Washington, DC, USA.Fred Hutchinson Cancer Center. Statistical Center for HIV/AIDS Research & Prevention. Washington, DC, USA.University of Washington. Department of Biostatistics. Seattle, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA / Fred Hutchinson Cancer Research Center. Bioinformatics and Epidemiology Program. Seattle, Washington, USA.University of North Carolina at Chapel Hill School of Medicine. Department of Medicine. Division of Infectious Diseases. UNC HIV Cure Center. California, USA.University of Rochester. Department of Medicine. Infectious Disease Division. Rochester, New York, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.Biomedical Advanced Research & Development Authority. Division of Clinical Development. Washington, DC, USA.National Institutes of Health. National Institute of Allergy and Infectious Disease. Vaccine Research Program. Division of AIDS. Bethesda, Maryland, USA.National Institutes of Health. National Institute of Allergy and Infectious Disease. Vaccine Research Program. Division of AIDS. Bethesda, Maryland, USA.University of Maryland. Department of Medicine. Baltimore, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA / University of Washington. Department of Laboratory Medicine and Pathology. Seattle, Washington, USA.Fred Hutchinson Cancer Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA / University of Washington. Department of Global Health. Seattle, Washington, USA.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.porAmerican Medical AssociationRapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trialsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleCOVID-19PandemicSARS-CoV-2COVID-19 vaccinesConduct Phase 3info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/57779/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALve_Lora_Alfredo_etal_INI_2023.pdfve_Lora_Alfredo_etal_INI_2023.pdfapplication/pdf1178256https://www.arca.fiocruz.br/bitstream/icict/57779/2/ve_Lora_Alfredo_etal_INI_2023.pdfc0ecffcdaf39ac4a76d5bf7f50e9b8bbMD52icict/577792023-04-14 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| dc.title.en_US.fl_str_mv |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials |
| title |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials |
| spellingShingle |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials Lora, Alfredo J. Mena COVID-19 Pandemic SARS-CoV-2 COVID-19 vaccines Conduct Phase 3 |
| title_short |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials |
| title_full |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials |
| title_fullStr |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials |
| title_full_unstemmed |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials |
| title_sort |
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials |
| author |
Lora, Alfredo J. Mena |
| author_facet |
Lora, Alfredo J. Mena Long, Jessica E. Huang, Yunda Baden, Lindsey R. Sahly, Hana M. El Follmann, Dean Goepfert, Paul Gray, Glenda Grinsztejn, Beatriz Kotloff, Karen Rouphael, Nadine Sobieszczyk, Magdelena Walsh, Stephen R. Andriesen, Jessica Shah, Karan A. Yuanyuan, Zhang 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. |
| author_role |
author |
| author2 |
Long, Jessica E. Huang, Yunda Baden, Lindsey R. Sahly, Hana M. El Follmann, Dean Goepfert, Paul Gray, Glenda Grinsztejn, Beatriz Kotloff, Karen Rouphael, Nadine Sobieszczyk, Magdelena Walsh, Stephen R. Andriesen, Jessica Shah, Karan A. Yuanyuan, Zhang 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. |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Lora, Alfredo J. Mena Long, Jessica E. Huang, Yunda Baden, Lindsey R. Sahly, Hana M. El Follmann, Dean Goepfert, Paul Gray, Glenda Grinsztejn, Beatriz Kotloff, Karen Rouphael, Nadine Sobieszczyk, Magdelena Walsh, Stephen R. Andriesen, Jessica Shah, Karan A. Yuanyuan, Zhang 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. |
| dc.subject.en.en_US.fl_str_mv |
COVID-19 Pandemic SARS-CoV-2 COVID-19 vaccines Conduct Phase 3 |
| topic |
COVID-19 Pandemic SARS-CoV-2 COVID-19 vaccines Conduct Phase 3 |
| description |
COVID-19 Prevention Network: Daniel Reirden, Lilly Immergluck, Colleen Kelley, Anna Durbin, Milagritos Tapia, Megan Deming, Karen Kotloff, Jorge Pinto, Paul Goepfert, Zaheer Hoosain, Johan Lombaard, Kathryn Stephenson, Lindsey Baden, Stephen 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 Wohl, Cindy Gray, Chrinstine Turley, Temitope Oyedele, Babafemi O Taiwo, Karen Krueger, Rick Novak, Beverly E Sha, Laura Hammit, Carl Fichtenbaum, David Bernstein, Jeffrey Jacobson, Dima Dandachi, Hasan Naqvi, Susan 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 Walter, Jeff Henderson, Hugo Tempelman, Abraham Siika, Evan Anderson, Brenda Okech, Richard Rupp, Hana El Sahly, Catherine M Healy, Robert Arduino, Patricia Winokur, Martin Casapia, Gailen Marshall, Bhagyashri D Navalkele, Sharla Badel-Faeson, Ian Sanne, Lee Fairlie, Adeodata Kekitiinwa, Patricia Ntege, Peter J Elyanu, Cissy K Mutuluuza, Sandra Rwambuya, Philippa Musoke, Deo Wabwire, Barbara Pahud, Mario Castro, Fredrick Sawe, Samuel G Ouma, Taraz Samandari, Grace Mboya, Craig Innes, Philip Kotze, Javier Lama, Jorge Sanchez, Jorge Gallardo, Pedro Gonzales, Robinson Cabello, Raphael Landovitz, Michael P Dube, Tamela Gould-Porter, Steve Shoptaw, Jesse Clark, Sheena Kotze, Olivia Kasselman, Katherine Gill, Maphoshane Nchabeleng, Aditya Gaur, Carlos Cabrera, Susanne Doblecki-Lewis, Susan Kline, Scott McClelland, Mandaliya Kishorchandra, Pamela Mda, Thozama Dubula, Walter Jaoko, Spyros Kalams, David Haas, Vladimir Berthaud, Clarence Creech, Sue Ellen Abdalian, Jessica Justman, Delafontaine, Kristen Marks, Sharon Mannheimer, Hong Van Tieu, Magda Sobieszczyk, Mark Mulligan, Vanessa Raabe, Mary Olson, Juanita Erb, Shobha Swaminathan, Jose Pilotto, Christopher Hall, Diana Florescu, Edwin de Jesus, Ian Frank, Katie Barr, Deborah McMahon, Sharon Riddler, Judith M Martin, Elizabeth Barranco, Breno Santos, Karen Tashima, Beatriz Grinsztejn, Esau J Filho, Mike Keefer, Ann Falsey, William Brumskine, Stuart Cohen, Jason Okulicz, Barbara Taylor, Thomas Patterson, Ryan Maves, Susan Little, Susan Buchbinder, Annie Luetkemeyer, Carmen Zorrilla, Esper Kallas, Vivian A Silva, Tamara Newman, Jose Valdez Madruga, Julie McElrath, Lisa Jackson, Anna Wald, Mookho Malahleha, Fatima Laher, Erica Lazarus, Anusha Nana, Daniel Hoft, Sharon Frey, Rachel Presti, Sharon Nachman, Benjamin Luft, Carina Rodriguez, Kathy Mngadi, Eric Daar, Shaun Barnabas, Mark Cotton, Stephen Spector, Karen Servilla, Kathleen A Linder, Abeer Moana, Carol Kauffman, Mary Bessesen, Rohit Talwani, Louis Dell'Italia, Augusto Alonto, Daniel Liebman, Roger Bedimo, Christopher Woods, Peruvemba Sriram, Kalpana Padala, Gregory Holt, Edwin Swialto, Melanie Jay, Sabrina Felson, Nora Henderson, Sheldon Brown, Saumuel Aguayo, Mark Riddle, Phyllis Tien, John Toney, Halima Dawood, Disebo Makhaza, Hugh Mighty, Siham Mahgoub, Wes Campbell, David Diemert, Tiffany Schwasinger-Schmidt, Caryn G Morse, John W Sanders, John Williamson, Angelique Luabeya, Elizabeth Bukusi, Nelly Mugo, Hannah Kibuuka, Betty Mwesigwe, Andrew Kambugu, Apolo P Balyegisawa, Kathleen Mullane, Ben Andagalu, Lucas Tina, Nathaniel Copeland, Jack Hutter, Claudio L de Las Casas, Guillermo Ruiz-Palacios, Joseph J Eron, Judith S Currier, Myron S Cohen, Kami Kim, Richard N Greenberg, Margaret Kasaro, Sinead Delaney-Moretlwe, Rodney Dawson, Carmen Paez, Nicole Grunenberg, William O Hahn, Huub C Gelderbloom, Michele P Andrasik, Stephaun E Wallace. |
| publishDate |
2023 |
| dc.date.accessioned.fl_str_mv |
2023-04-14T13:09:26Z |
| dc.date.available.fl_str_mv |
2023-04-14T13:09:26Z |
| dc.date.issued.fl_str_mv |
2023 |
| dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
| dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.citation.fl_str_mv |
LORA, Alfredo J. Mena et al. Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials. JAMA Network Open, v. 6, n. 1, p. 1-15, Jan. 2023. |
| dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/57779 |
| dc.identifier.issn.en_US.fl_str_mv |
0098-7484 |
| dc.identifier.doi.none.fl_str_mv |
10.1001/jamanetworkopen.2022.51974 |
| dc.identifier.eissn.none.fl_str_mv |
2574-3805 |
| identifier_str_mv |
LORA, Alfredo J. Mena et al. Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials. JAMA Network Open, v. 6, n. 1, p. 1-15, Jan. 2023. 0098-7484 10.1001/jamanetworkopen.2022.51974 2574-3805 |
| url |
https://www.arca.fiocruz.br/handle/icict/57779 |
| dc.language.iso.fl_str_mv |
por |
| language |
por |
| dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
| eu_rights_str_mv |
openAccess |
| dc.publisher.none.fl_str_mv |
American Medical Association |
| publisher.none.fl_str_mv |
American Medical Association |
| dc.source.none.fl_str_mv |
reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
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FIOCRUZ |
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Repositório Institucional da FIOCRUZ (ARCA) |
| collection |
Repositório Institucional da FIOCRUZ (ARCA) |
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https://www.arca.fiocruz.br/bitstream/icict/57779/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/57779/2/ve_Lora_Alfredo_etal_INI_2023.pdf |
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Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ) |
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repositorio.arca@fiocruz.br |
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