Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data

In this cross-protocol analysis, the TND provided reliable inferences on COVID-19 vaccine effectiveness in health care-seeking populations for multiple vaccines and symptom definitions when confounding and selection bias were absent. A machine-learning approach for robust confounding control in postmarketing TND studies was also introduced.

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Journal
JAMA Network Open
Published
2025-05-28
DOI
https://doi.org/10.1001/jamanetworkopen.2025.12763
Citations
4
Primary Topic
SARS-CoV-2 and COVID-19 Research
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article
Field-Weighted Citation Impact
5.58

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article

Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data

Eric Bravo, Richard Gibson, Blanca Gomez, Weiping Deng et al.
4 citations
JAMA Network Open
SARS-CoV-2 and COVID-19 Research
5.58
article

Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data

Eric Bravo, Richard Gibson, Blanca Gomez, Weiping Deng, Jon F. Dedon, Shelly Ramirez, Dean M. Boswell, Hala Webster, Dima Dandachi, Michele Haynes, Sanjay Gurunathan, Theresa Hegmann, Allison O'Brien, Eric N. Miller, Tameika Scott, Therese Takas, Angela R Branche, Richard Starlin, Laurie J. Han-Conrad, Will Hernandez, Luz Marina Zapata, Christina Bacher, Robert L. Atmar, E. Adrianne Hammershaimb, Susan L. Koletar, Leah Andrews, Florida Aristy, Jennie Johnson, Somnath Mangarule, Laura Stulken, Jalima Quintero, Gregory Utz, Roger Masotti, Martín Bäcker, Amit Paliwal, Nessryne Sater, William C. Kirby, Ian Hirsch, Guillermo M. Ruiz‐Palacios, Gregory Gottschlich, Alice McGarry, Paul E. Kilgore, Rebecca Zash, Brittany Feijoo, Elizabeth Bruce, Lilly Cheng Immergluck, Philip Ponce, Jon M. Finley, Lyly Dang, David B. Musante, Dipesh Tamrakar, Nina Ahmad, Marian E. Shaw, María José Reyes Fentanes, Satoshi Kamidani, Quito Osuna Carr, Lauren Clement, Gregory Holt, Michal Juraska, S. Hasan Naqvi, Niles Eaton, Carmel B. Dyer, Patty Reed, Millie Manalo, Emmanuel B. Walter, Jeffery L. Meier, Melanie Jay, Brit Sovic, Patrick A. Flume, Fred E. Newton, Paul Matherne, Nuchra Sirisuphmitr, Richard Calderone, Cynthia Montano-Pereira, Judith Borger, Michele P. Andrasik, Matthew Sims, Hong‐Van Tieu, Mark Turner, Shamika Huskey, Amit Suresh Bhate, Bindu Balani, Ariana C. Stanton, Wendell Lewis, Johannes Antony, Huub G. Gelderblom, Renea Henderson, Nicole Grunenberg, Emily Oppenheim, Amber Grant, S Green, Jill Maaske, Maggie Ann Bowers, Akiyoshi Uchiyama, Cynthia D. Brown, Carl Griffin, Charnell Cromer, Ronald Ackerman, Larkin T. Wadsworth, Carl J. Fichtenbaum, Stephen Morris, Satyajit Mohapatra, Esther L. Harmon, Corrina Pavetto, Danaya Chansinghakul, Yunda Huang, Jorge F. Méndez Galván, Adam Brosz, Bruce McClenathan, Karl M. Thompson, Keith Vrbicky, Evan Ewers, Beth D. Kirkpatrick, James Fry, Menelas N. Pangalos, María L. Alcaide, Erica L. Sanchez, Timothy R. Shope, Lisa Holloway, James E. Peacock, Marc Siegel, Siham M. Mahgoub, Yogesh K. Paliwal, Margaret Rhee, Kathleen A. Linder, Brendan Flannery, Glenda Gray, Elizabeth E. Robison, C. D. Wilson, Karla Zepeda, Chelsie Nutsch, Tiffany Esinhart, Jeremy Philip Brown, Tiffany Schwasinger‐Schmidt, Cornell Calinescu, Caroline Greene, Flora Castellino, Maria D. Mileno, R. Michelle Chouteau, Walter Patton, Georgi Shukarev, Joseph L. Newberg, David Joseph Diemert, Alexander M. Clark, Esther S. Huffine, Keith R. Jerome, William Schnitz, Timothy Wilkin, Gary J. Luckasen, Hanneke Schuitemaker, Janet Garvey, Johan Vingerhoets, Emma Bainbridge, Alpa V. Patel, Todd Simmons, Leslie Iverson, Videlis Nduba, Gregory Feldman, Sergio L. Vargas, Michelle Maxwell, Srilatha Edupuganti, Filip Dubovsky, Jack T. Stapleton, C.L. Mitchell, Haiyu Zhou, Nathan L. Alderson, Wayne L. Harper, Michelle Dickey, Ryan C. Maves, Dirk Heerwegh, Becky Martinez, Ryan Little, Mark Hutchens, Stephen A. 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Hill, Scott Borgetti, Parul Desai, Jennifer Winbigler, Valeria D Cantos, Tiffany Nemecek, Diana Badillo, Andrew McConnell, Hannah K. Harrington, Peter Winkle, Evelyn F. Hall, Christine B. Turley, Ying Huang, Thomas Campbell, Carrie D. Johnston, Lawrence J. Purpura, Sarah E. Rutstein, Michael P. Fay, Iksung Cho, William Seger, Richard P. Marshall, Vicki E. Miller, Hiroyuki Fukase, Lazaro Gonzalez, Elizabeth R. Duke, Douglas Denham, Carina Frago, Marı́a Elena Santolaya, Rebecca Boas, Jeffrey A. Klein, LaTeshia Thomas-Seaton, Michael Hassman, Juan Pablo Torres, Carlos Río, Joseph J. Eron, Jennifer A. Foley, Kathleen M. Mullane, Stephen R. Walsh, Beatriz Gilda Jegerhorn Grinsztejn, Karen L. Kotloff, Kenneth Hugh Mayer, Teresa Deese, Javier Martínez, Susan Buchbinder, Milagritos Tapia, Paul A. Goepfert, Jill York, Kate Zenlea, Karen Deutsch, Melissa Anne Carr, Getahun Abate, Matthew Hong, Mary Easley, David G. Taylor, Marshall Nash, Morgan McLaughlin, Maryam Keshtkar‐Jahromi, Diana Vegas, Thomas Weiss, Sebastian Garcia Escallon, Jaleh Ostovar, Mark Eickhoff, Ramin S. Herati, Timothy W. Schacker, James G. Kublin, Samuel Gurrion Ouma, Kristin J. Marks, David R. Andes, Amy Medina, Paulina A. Rebolledo, Hector Velásquez, Martha Sanchez, John Amuasi, Adrienna Marquez, Dalia Tovar, Humberto Reynales, Katherine Stapleton, Dianca Sierra, Lynn Eckert, Sybil Hosek, Zudi-Mwak Takizala, Daniel F. Hoft, Mario Castro, Paola Lichtenberger, Susan Kline, Kacie Sales, Alejandro Hoberman, Hillary Dunlevy, Simmy Pinto, Matthew J. Hepburn, Natasha Wilson, Kishorchandra Mandaliya, Valerie Arnold, Sarah Galloway, Eric McGrath, Erin Cooksey, Cynthia Strout, Thomas A. Mellman, Susan J. Little, Matthew Bonaparte, Ronald Lubelchek, Gregory M. Glenn, Annette R. Bennett, Zachary S. Bittner, Brian Chow, Laura Julia Camacho Choza, Waseem Chughtai, James Kopp, Stephanie Andree, Ashley Kennedy, Winston Cavert, Michael J. 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Abstract

In this cross-protocol analysis, the TND provided reliable inferences on COVID-19 vaccine effectiveness in health care-seeking populations for multiple vaccines and symptom definitions when confounding and selection bias were absent. A machine-learning approach for robust confounding control in postmarketing TND studies was also introduced.

JAMA Network OpenVol. 8(5)
Florida State University (US), AstraZeneca (United Kingdom) (GB), Brigham and Women's Hospital (US), Centers for Disease Control and Prevention (US), National Institutes of Health (US), Grady Memorial Hospital (US), New York Blood Center (US), Janssen (Belgium) (BE), Emory University (US), Baylor College of Medicine (US), University of Washington (US), University of Chicago (US), Fred Hutch Cancer Center (US), Grady Health System (US), Moderna Therapeutics (United States) (US), Sanofi (United States) (US), National Institute of Allergy and Infectious Diseases (US), University of Colorado Anschutz Medical Campus (US), University of Rochester (US), Stony Brook University (US), Columbia University (US), Fogarty International Center (US)
National Institute of Allergy and Infectious Diseases
Good health and well-being
Openalex Percentile: Top 4%
SARS-CoV-2 and COVID-19 Research
5.58
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