Accès ouvert déclaré 2025 article

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

Leah I. B. Andrews, M. Elizabeth Halloran, Lars van der Laan, Yunda Huang, Jessica G. Andriesen, Mayur Patel, Leigh H. Fisher, Holly E. Janes, Nadine Rouphael, Stephen R. Walsh, Deborah Theodore, Hong‐Van Tieu, Magdalena E. Sobieszczyk, Hana M. El Sahly, Lindsey Robert Baden, Ann Regina Falsey, Thomas Campbell, Colleen Frances Kelley, Catherine Mary Healy, Lilly Cheng Immergluck, Benjamin J. Luft, Ian Hirsch, Guy de Bruyn, Carla Truyers, Frances Priddy, Kelsey M. Sumner, Brendan L. Flannery, Dean A. Follmann, Peter B. Gilbert, Vanessa Abad, Karina Abalos, Getahun Abate, Anum Abbas, José Accini, Ronald T. Ackerman, Jamie Ackerman, Jeremy Ackermann, Atoya Adams, Michael R. Adams, Mark S Adams, Michael R. Adams, Jeffrey M. Adelglass, Sarah Afework, Nina Ahmad, Christine M. Akamine, Julie A. Ake, Gary R. Albert, Maria Luisa Alcaide, Nathan L. Alderson, Lily Aleman, José O. Alemán, Mohamed S Al-Ibrahim, Mohammed Basel Allaw, Leland N. Allen, Mary H. Allen, Naveena Aloysia, Hilario Alvarado, Winniberg Stephany Alvarez León, Carmen Amador, John Amuasi, James Andersen, Evan J. Anderson, Corey G. Anderson, Victoria R. Anderson, David R. Andes, Michele Peake Andrasik, Stephanie Andree, Jeb Andrews, Victoria Andriulis, Germán Áñez, Maria Angeles Ceregido, Nana Akosua Ansah, Jessica L. Ansel, Codi M. Anthony, Johannes Antony, Mohammed Antwi, Roberto C. Arduino, Florida Aristy, Valerie K. Arnold, Alicia Arrazcaeta, Hugo Macareno Arroyo, Kwaku Poku Asante, Robert L. Atmar, Allison August, Ayoade Avworo, Christina Bacher, Martín Bäcker, Lindsay R. Baden, Diana Badillo, Emma Bainbridge, Michele Baka, Sherrie Baker, Bindu Balani, B.A. Ball, Mira Baron, Dan H. Barouch, Elizabeth Barranco-Santana, Alejandro Quintín Barrat Hernández, Darlene Bartilucci, Jennifer Bashour, Teresa A. Batteiger, Clarisse Baudelaire, George Howard Bauer, José A. Bazan, María Gabriela Becerra, Cynthia Becher Strout, Teresa M. Becker, David L. Beckmann, Roger Bedimo, Linda R. Belhorn, Genevieve Beninati, Jorge A. Benítez, David C. Benkeser, Annette R. Bennett, Elizabeth L. Bennett, Tatiana H. Beresnev, Aude Berge, Megan A. Berman, Maria I. Bermudez, Marcia Bernard, David I. Bernstein, Jennifer N. Berry, Andrea A. Berry, Vladimir Berthaud, Hanna Beyko, Kristin Bialobok, Joanne L. Billings, Oleksandra Bilotkach, Zachary S. Bittner, Jeanne Blevins, Jill S. Blumenthal, Rebecca Boas, Joseph A. Bocchini, Tyler D. Bold, Matthew I Bonaparte, Alison Bondell, P. K. Bondy, Judith Borger, Scott A. Borgetti, Joseph Boscia, Dean M. Boswell, Tana Bourgeois, Maggie Ann Bowers, Paul S. Bradley, Judith Brady, Riemke M Brakema, Andres Bran, Angela R Branche, Boerries Brandenburg, Donald M. Brandon, Eric Bravo, Thomas Breuer, Margaret Brewinski Isaacs, Liz Briesemeister, Toby Briskin, Gail B. Broder, Adam B. Brosz, David A. Browder, Lesley H. Browder, Jeremy Philip Brown, Cynthia D. Brown, Robert W. Brownlee, Elizabeth Bruce, Susan Buchbinder, Cynthia Marchiori Bueno, Elisabeth Bukusi, Delia Bullock, Catherine A. Bunce, Cortney Burch, Michelle L. Burgett, Abram H. Burgher, Larry Marc Bush, Michael B. Butcher, Robert J. Buynak, LaShondra Cade, Richard Calderone, Amy Caldwell, Cornell V. Calinescu, Robert S. Call, Jim Callis, Laura Julia Camacho Choza, Andrés Camacho-González, Wesley R. Campbell, Michael R. Cancilla, Kevin D. Cannon, Karina Cano Martínez, Richard J Canter, Valeria D Cantos, Vicky Cárdenas, Martha Carmen Medina, Ellie R. Carmody, Christopher F Carpenter, Melissa Anne Carr, Monica B. Carrascal, Jaime Augusto Carrillo, Steven E. Carsons, Marianela Carvajal, Denise Casey, Jorge Caso, Flora Castellino, Marvin Castellon, Jose Castillo Mancilla, Mario Castro, Hannah Catan, Nancy Cauwenberghs, Winston P. Cavert, Médéric Celle, Jorge A. Chacón, Mesha M. Chadwick, Amy Chamberlain, Austin Chan, Jennifer J. Chang, Danaya Chansinghakul, Mouna G. Chebib, Corey M. Chen, Aiying Chen, Margaret Harris Cheng, Roman M. Chicz, Iksung Cho, Karin Choquette, R. Michelle Chouteau, Brian D. W. Chow, Lisa Chrisley, Shane G. Christensen, Laurence Chu, Hanh Thi Chu, Waseem Chughtai, Michael Chung, Annie Ciambruschini, Cristina E Cicogna, Alexander Michael Clark, Jesse L. Clark, Phillip Claybrook, Andrea Clement, Lauren Clement, Steve Clemons, Heather Clouting, Lisa B. Cohen, Stuart H. Cohen, Jacob Coleman, Joseph P. Connor, James H. Conway, Erin Cooksey, Robert W. Coombs, Maureen Cooney, Deanna Cooper, PAUL M. COPLAN, Lawrence Corey, Raymond L. Cornelison, Barbara Corral, Jordan Coslet, Erin Coston, Michael J. Cotugno, Florence Coux, Jessica Cowden, Paul Cramer, Clarence Buddy Creech, Charnell Cromer, Marshall A. Cross, Aurelio Cruz-Valdéz, Marcel E. Curlin, LaKondria Curry, Jerome H. H. V. Custers, Erika A. Cutz, Eric S. Daar, Michelle DallaPiazza, Dima Dandachi, Elizabeth Danford, Lyly Dang, Stephen R. Daniels, Chandan Krushna Das, Santa Kumar Das, Matthew John Davies, Yvonne Davis, Joseph D. Davis, William S. Davis, William B. Davis, Matthew Davis, Rajesh K. Davit, Gustavo H. Dayan, Anne Marit de Groot, Luis I. De La Cruz, Claudia De La Matta Rodriguez, Ian De Proost, Christopher Dedon, Jon F. Dedon, Teresa Deese, Emily Degan, Elliot N. DeHaan, Edwin DeJesus, Michael S. Delgado, Mike Delgado, Ernesto Delgado, David Dellaero, Weiping Deng, Douglas Scott Denham, Chinar Desai, Parul Desai, Michael C. Desjardins, Karen F. Deutsch, Michael E. Dever, Naomi Devine, Louis Devlin, Carlos A. DiazGranados, Secia Díaz-Miralrio, Michelle Dickey, David Joseph Diemert, Craig Dietz, Susanne Doblecki‐Lewis, D.V. Dobrianskyi, Jennifer L Dong, Tambra Dora, Brenda Dorcely, Macaya Douoguih, Matthew W. Doust, Frances Downing, Michael P. Dubé, Filip Dubovsky, Pete Ducheneaux, Jeffrey R. Dugas, Aeiress Duhart, Elizabeth R. Duke, Debora Dunbar, Haoua Dunbar, Daniel M. Duncanson, Lisa M. Dunkle, Hillary Dunlevy, Anna P. Durbin, Amy Dye, Carmel B. Dyer, Sarah Dzigiel, Mary Easley, Niles Eaton, Valentine M. Ebuh, Georgette Ebuh, Lynn Eckert, Benjamin J. Eckhardt, Frank S. Eder, Srilatha Edupuganti, Leslie A. Edwards, Mark Eickhoff, Edward F. Ellerbeck, Grant B. Ellsworth, Elwaleed Elnagar, Victoria Engler, Kendra J. Enright, David J. Ensz, Sally Eppenbach, Sandra K. Erickson, Joseph J. Eron, Joseph J. Eron, Tiffany Esinhart, Claudia Espinosa, Luis Espinoza, Brandon J. Essink, Elizabeth Everette, Evan C. Ewers, Beverly Ewing, Amy Falk, Norberto Fas, Michael P. Fay, Szheckera Fearon, Brittany Feijoo, Gregory Feldman, Uriel R. Felsen, Hein Fennema, Carl J. Fichtenbaum, Tom Fiel, Carlos A. Fierro, Kenneth Finkelstein, Jon M. Finley, Suzanne P. Fiorillo, David Fitzpatrick, Diana F. Florescu, Patrick A. Flume, Charles M. Fogarty, Jennifer A. Foley, Pink Folmar, Lyndsea Folsom, Youyi Fong, Stacy Ford, Lina M. Forero, Les B. Forgosh, Elizabeth Formentini, Rhodna Fouts, Carina Frago, Veronica G. Fragoso, Doris Franco-Vitteri, Ian Frank, George H. Freeman, Lena R. Freese, Robert W. Frenck, Karen Freudemann, Sharon E. Frey, David L. Fried, Luke Friesen, James Fry, Bo Fu, Hiroyuki Fukase, Dawn Furey, Chris Galloway, Sarah Galloway, Edgar García, Jenina Garcia, Iris Garcia‐Martínez, Sebastian Garcia Escallon, Veronica Garcia-Fragoso, Agnes Garinga, Janet Garvey, Cynthia L. Gay, Bruce C. Gebhardt, Grant Geiger, Huub G. Gelderblom, Georgettea Geuss, Elham Ghadishah, Elie G. Gharib, Suzanne L. Gharib, Richard Gibson, Alfredo Gilberto Guerreros Benavides, Teletha Gipson, Eneyda Giuvanela Llerena Zegarra, Gregory M. Glenn, Richard M. Glover, Erin A. Goecker, Paul Goepfert, James N. Goldenberg, Blanca Veronica Hernández Gomez, Martha Cecilia Gómora Madrid, Jose Armando Gonzales Zamora, Celia González, Lazaro Gonzalez, Viviana Andrea Dosman González, Claudia González, Luis H. González, Denisse Alejandra González Estrada, A González‐López, Sarah Gordon, Bryan C. Gordon, Richard L. Gorman, Gregory M. Gottschlich, Melissa Gottschlich, Shanda Gower, Daniel S. Graciaa, Barney S. Graham, Irene L. Graham, Maria Angelica Granados, Amber Grant, Brett Gray, Glenda Gray, Roni Gray, Sinikka L. Green, Allison M. Green, Justin A. Green, Rusty Greene, Caroline Greene, Cathy Greiwe, Alexander L. Greninger, Carl Griffin, Marie-Hélène Grillet, Joseph A. Grillo, Beatriz Gilda Jegerhorn Grinsztejn, Robert M Grossberg, Nicole A. Grunenberg, Bernard Grunstra, Juan V. Guanira, Sonia Guerrero, Lea Guillery, Clint C. Guillory, Caitlin J. Guiney, Catherine Q. Gular, Shauna H. Gunaratne, Sanjay Gurunathan, Milton Haber, Greg Hachigian, Amina Z. Haggag, William O. Hahn, Evelyn F. Hall, David Halpert, Holli Hamilton, Elizabeth Adrianne Hammershaimb, Shu Han, Laurie J. Han-Conrad, Kate Harden, Karin Hardt, Esther L. Harmon, Wayne L. Harper, Charles Harper, Nicole Harrell, Hannah K. Harrington, Tavane Harrison, Kristina Harrison, Shana Harshell, William R. Hartman, Robyn Hartvickson, Michael Hassman, Timothy J. Hatlen, Kirsten A. Hauge, Lynne A. Haughey, Gary F. Headden, C. Mary Healy, Parke Hedges, Dirk Heerwegh, Theresa E. Hegmann, Jessica Heimonen, Destiny S. Heinzig-Cartwright, Sheryl L. Henderson, Jeffrey A. Henderson, Renea Henderson, Jenny Hendriks, Gayle D. Hennekes, Matthew J. Hepburn, Ramin Sedaghat Herati, Erica S. Herc, Will Hernandez, Laura Hernandez Guarin, Maria Hernandez Moran, Robin Hilder, John M. Hill, Janet E. Hill, Ken S. Ho, Alejandro Hoberman, Daniel Fredric Hoft, Leila S Hojat, Troy Holdeman, Ripley R. Hollister, Lisa A. Holloway, Gregory A. Holt, Matthew K. H. Hong, Stephan Hong, Rosamond Hong, Amanda Horn, Manisha Horton, Gary Horwith, Sybil Hosek, Cyrus Hoseyni, Patty Howenstine, Ying Huang, Kathy Hudzina, Cory J. Huffine, Esther S. Huffine, Christine C. Hull, Julie Hunt, John Hural, James Willard Hurst, Shamika Huskey, Mary Hussain, Julie Hussey, Morgan Hussey, Mark Hutchens, Tanya Hutchins, Julia Hütter, Vincent Huynh, Jessica Ibarra, Dilek İnce, Sarah M. Ingalsbe-Geno, Asha Inniss, Farah Gillian Irani, Mashrur Islam Majumder, Ryan B. Israelsen, Leslie K. Iverson, Genevieve Iwuala, Lisa A. Jackson, Peta-Gay Jackson-Booth, Michael A. Jacobs, Colleen Jacobsen, Jeffrey M. Jacobson, Jeffry Jacqmein, Kate Jaegle, Shireen H. Jaffer, Maryam Jahromi, Manish Kumar Jain, Frank James, Melanie R Jay, Robert J. Jeanfreau, Susan Jeanfreau, Will Jennings, Natasa Jenson, Keith R. Jerome, Jennifer A. Johnson, John L. Johnson, Danyel Johnson, Diane Johnson, Marı́a Cecilia Johnson, Lisa Johnson, Erica L. Johnson, Kristen M. Johnson, Jennie E Johnson, Carrie D. Johnston, William P. Jones, Kathleen S. Jones, Edward C. Jones‐López, B. Jordan, Michal Juraska, Jarek Juraszek, Jessica E. Justman, Seyram Kaali, Scott Kahney, Spyros A. Kalams, Satoshi Kamidani, Sheetal Kandiah, Pamela Kane, Piush Kanodia, Shashi N. Kapadia, Lois Anne Katz, Melinda Katz, Carol A. Kauffman, Daniel R. Kaul, Margaret Kautz, Westly Keating, Jia Jin Kee, Michael C. Keefer, Wendy A. Keitel, Amy S. Kelley, Kary Kelly, Elizabeth J. Kelly, Sandra Kelman, Gerald Kelty, Ashley Kennedy, Christina Kennelly, Maryam Keshtkar‐Jahromi, Jill Kessler, Nzeera Ketter, Najat S. Khan, Nitin Khandelwal, Shishir K. Khetan, Saadia Khizer, Hannah N. Kibuuka, Kristen Kiersey, Paul Evan Kilgore, Anthony Kim, Kami Kim, Murray A. Kimmel, Michelle King, Jeffrey K. Kingsley, William C. Kirby, John Andrew Kirby, Beth D. Kirkpatrick, Judith Lee Kirstein, Noah Kiwanuka, Francis Kiweewa, John S. Kizer, Terry D. Klein, Thomas C. Klein, Tracy R. Klein, Jeffrey Alan Klein, Susan Kline, David Kline, Jennifer Knishinsky, Jennifer Knowles, Laura Kogelman, Sharon Kohrs, Susan L. Koletar, James Kopp, Michael J. Koren, Chalit Kosolsak, Karen L. Kotloff, Angelica C Kottkamp, Marguerite Koutsoukos, Jayasree Krishnankutty, Mara Kryvicky, James G. Kublin, Kristine J. Kucera, Darshna Kukian, Marcy Kulic, Rebecca J. Kurnat, Kelly Kush, Jitendra Singh Kushwaha, Mark E. Kutner, Ben Ladner, Cathy Laflan, Maryrose R Laguio-Vila, Sherry Lamberth, Raphael J. Landovitz, Dakotah C. Lane, Thelma M. Laot, Anyela Lara, Matthew B. Laurens, Andrew Lauria, Daniel T. Lawler, Nga Le, Mathieu Le Gars, Vickie Leathers, Brett A. Leav, Logan Ledbetter, Julie E. Ledgerwood, Kia Lee, Jessica L. Lee, Marina Lee, Angela Y. Lee, Mark T. Leibowitz, Natalia Leistner, Mark J. Lerman, Michael L. Levin, Brendan Levy, Phillip David Levy, Wendell Lewis, Michael Lewis, Derek Lewis, Maggie Lewis, Paola Lichtenberger, Amanda Lilienthal, Kathleen A. Linder, Carol Ann Linebarger, Kendra Lisec, Ryan Little, Susan J. Little, Albert Liu, Anna S. Lok, Evelyn Lomasney, James Longe, Carlos Ynigo Lopez, Eduardo López-Medina, Julia Sparks Lord, James E. J. Lovell, Ronald Lubelchek, John Lucaj, Njira Lucia Lugogo, Gary J. Luckasen, Gregg H. Lucksinger, Annie F. Luetkemeyer, Rafael Lupercio, Alisha Lutat, Jill Maaske, Rosa MacBryde, Nolan Mackey, Rebecca Pellett Madan, Janine R. Maenza, Siham M. Mahgoub, Mamodikoe Makhene, Hussain Malbari, Elissa M. Malkin, Carlos Malvestutto, Stephanie Mamod, Millie Manalo, Kishorchandra N. Mandaliya, Somnath Mangarule, Padma N. Mangu, Mary Beth Manning, Rickey D. Manning, Deb Manzo, Horacio Marafioti, Kristin J. Marks, Mary Marovich, Adrienna Marquez, Richard P. Marshall, Judith M. Martin, T.R. Martin, Becky Martinez, Reuben Martinez, Javier Martínez, Silvano Omar Martínez Pérez, John R. Mascola, Robín Masón, Roger Masotti, Paul G. Matherne, Christopher Matich, Monica Mauri, Ryan C. Maves, Michelle Maxwell, Kenneth Hugh Mayer, Monica A. McArthur, Jennifer McCarter, Michael J. McCartney, R. Scott McClelland, Bruce M. McClenathan, Rachael McClennen, Andrew McConnell, Margaret McCort, M. Juliana McElrath, Charlene McEvoy, Alice McGarry, John W. McGettigan, Jonlyn McGettigan, Lora J. McGill, Eric J McGrath, Mark M. McKenzie, Cecilia McKeown-Bragas, Irene McKnight, Morgan McLaughlin, Meredith McNairy, Kelly McQuarrie, Andrew D. McWilliams, Jodi Meck, Surisday Mederos, Amy Medina, Carmen Medina, Jeffery L. Meier, Thomas Alan Mellman, Jessica M. Mena, Lisa Menard, Kathleen Menasche, Janet Méndez, Jorge F. Méndez Galván, Rafael Mendoza‐Meroño, Erika Mendoza, Sandra Mendoza, Rajan K. Merchant, Fernando L. Merino, David C. Metzger, Jay W. Meyer, Robert F. Meyer, Eric Allan Meyerowitz, Nelson L. Michael, Randle Middleton, Maria Denise Mileno, Matthew Miles, Chelsea Miles, Eric N. Miller, Jacqueline M. Miller, Vicki E. Miller, Meagan Elizabeth Miller, Paulina Miller, Jason Milligan, Ann Marie Milliken, Jill E. Miracle, Vincent Mirkil, Mehdi Seyed Mirsaeidi, Carol L. Mitchell, Kazuyuki Mizuyama, Gowdhami Mohan, Satyajit Mohapatra, Sharzhaad Molina Guizar, Florence Marie Momplaisir, Cynthia L. Monaco, Cynthia Montano-Pereira, Natasha Montoya, Candice Montros, Amaran Moodley, Fernanda Morales Berstein, Caitlin Anne Moran, Catherine A. Moreau, Stephen Lloyd Morris, Victoria Mosteller, Stefanie Mott, Connie Moya, T. H. Moye, Kimberly Diggle Mueller, Nancy B. Mueller, Jacqueline Muenzner, Nelly Mugo, Sauda Muhammad, Kathleen M. Mullane, Mark J. Mulligan, Gysella B. Muniz, Sigridh Muñoz-Gómez, Sonal S. Munsiff, Deborah Murray, Monica Murray, Linda Murray, David B. Musante, Sharon Nachman, Shinya Nagamatsu, Sherif Naguib, Jerome G. Naifeh, S. Hasan Naqvi, Marshall Nash, Julio Nasim, Martha Nason, Videlis Nduba, Paul Nee, Rosa Negron, Marguerite A. Neill, J C Nelson, Taylor Nelson, Tiffany Nemecek, Lori A. Nesbitt, Sonja Neumeister, Hannah Nevarez, Joseph L. Newberg, Lauren C. Newhouse, Patrick Newingham, Fred E. Newton, Lucy Ng-Price, Kimberly Nieves, Chimeremma D. Nnadi, Kimberly Nofz, Nicole L. Nollen, Asif Noor, Fernando Noriega, Richard Novák, Patricia Nahirya Ntege, Paul J. Nugent, Claudio Nuñez Lagos, Cheryl Nuss, Chelsie Nutsch, Amesika N. Nyaku, Allison O'Brien, Enrique Ocaña, Amanda Occhino, Kim Offergeld, Brenda Apio Okech, Tracy Okonya, Jason F. Okulicz, Oyebisi Olanrewaju, Shelby Olds, Marcia A. O’Leary, Patrick A. Oliver, Odette Olivieri, Jocelyn Zuleica Olmos Vega, Sarah Omodele, Allie Oplinger, Emily Oppenheim, Yaa D. Oppong, Jessica Ortega, Sandra Janeth Ortega Domínguez, Maricruz E. Ortegón, Masaru H. Oshita, Erica Osmundsen, Jaleh Ostovar, Quito Osuna Carr, María Calado Otero, Janet Otto, Samuel Gurrion Ouma, Jeffrey Scott Overcash, Temitope Oyedele, Janet Nyawira Oyieko, Janeth Pacheco-Flores, Carmen A. Paez, Barbara A. Pahud, Ruth Paiano, Rolando Pajón, Yogesh K. Paliwal, Amit Paliwal, Steven C. Palmer, David Pampe, Menelas N. Pangalos, Lalitha Parameswaran, Erwin Pardo, Mercedes Paredes, Purvi Y. Parikh, Elizabeth Parker, Susan Parker, Kevin Parks, Reza Parungao, Alpa V. Patel, Priti S. Patel, Thomas L. Patterson, JAN EVANS PATTERSON, Walter Patton, Leena Paul, Corrina Pavetto, Juana R. Pavie, James E. Peacock, Michele Peake-Andrasik, Laura Pearlman, Alyssa-Kay Peay, David Pekala, Alison C. Pellecchia, Issac Pena-Renteria, Penny Peng, Noris Peraita, Henry Peralta, Donna Percy, Isabel Pereira, Ashley Perez, James T. Peterson, Jennifer Petts, Taryn Petty, Mai Pham, Sharine Phan, Amanda Philyaw, Sikhongi Phungwayo, Judy Pi, Shelby Pickle, Paul Pickrell, Terry Piedra, Kristen K. Pierce, Daniela Pineda Méndez, Ruth Serrano Pinilla, Simmy Pinto, Rebecca L. Pitotti, DAVID L. PITRAK, April Pixler, Stanford Plavin, Laura Polakowski, Terry L. Poling, Philip Ponce, Laura R. Porterfield, Svitlana Postol, Amy L. Potts, Richard Powell, Margaret V. Powers‐Fletcher, E. Javier Pretell Alva, Patty Price-Abbott, Veronica Procasky, John R. Pullman, Lawrence J. Purpura, Marie-Laure Py, Evelyn Quevedo, Kim Quillin, D.J. Quinn, Jalima Quintero, Vanessa Raabe, Frederick Raiser, Sabina Raja, Vivek Rajasekhar, Danielle Raley, Mayur S. Ramesh, Natalie Ramirez, Shelly Ramirez, Wanda Ramon, James M. Ramsey, Bruce G. Rankin, Heather Rattenbury-Shaw, Paulina A. Rebolledo, Sergio E. Recuenco, Chinthaparthi Prabhakar Reddy, Patty Reed, Maria M. Regalado, M Regalado, María José Reyes Fentanes, Humberto Reynales, Michele D. Reynolds, Trina L. Reynolds, Michelle C. Reynolds, Margaret Rhee, Tamara Richards, Sha-Wanda Richmond, Sharon A. Riddler, Robert A. Riesenberg, Dolores Rijos, Joshua Rindt, Enrique Rivas, Juan J. Rivera, Maria Ivonne Rivera, Juana Rivera, Gina Rivero, Rafael Rivero, Zainab Rizvi, Barbara Rizzardi, Denise Roadman, Merlin Lee Robb, Afsoon D. Roberts, Toni Robinson, Dawn Robison, Elizabeth E. Robison, Shannon Rodman, Jessica Rodriguez, Carina A. Rodriguez, Edith Rodriguez, Rachel Rokser, Charlotte-Paige Rolle, Stephanie L. Rolsma, Peter Ronco, Melody Ronk, Adam B. Rosen, Jeffrey Bruce Rosen, David Rosenberg, A. Lina Rosengren, Christiana A. Rostad, Joan Rothenberg, Rambod Rouhbakhsh, Crystal Rowell, Pavitra Roychoudhury, Rola G. Rucker, Mónica Vallejo Ruiz, Vida Veronica Ruiz Herrera, Javier Ruiz‐Guiñazú, Guillermo M. Ruiz‐Palacios, Karen Ruperto, Richard E. Rupp, Sarah E. Rutstein, Natasha Rybak, Martin F. Ryser, JERALD C. SADOFF, Michelle Saemann, Beth Safirstein, Nafisa Saleem, Jamshid Saleh, Mansoor Noorali Saleh, Kacie Sales, Amy Salzl, Denise Sample, Robert Joel Samuels, Rosario Maribel Robles Sánchez, Martha C. Sanchez, Erica L. Sanchez, Pedro Luis Sanchez, Laura Ruy Sanchez Guerrero, Nelia Sánchez-Crespo, John W. Sanders, Lisa J. Sanders, Rica Santiago, Fredric Santiago, Marı́a Elena Santolaya, Nessryne Sater, Stephen J. Savarino, Fredrick Sawe, Carolyn Scatamacchia, Timothy W. Schacker, Gert C. Scheper, Linda M. Schipani, Christy Schmeck, Robert L. Schmidt, William Schnitz, Florian P. Schödel, Debra B. Schroeck, Lode Schuerman, Hanneke Schuitemaker, Howard I. Schwartz, Adam J. Schwartz, Howard Schwartz, Jennifer L. Schwartz, Tiffany E Schwasinger-Schmidt, Michael Sciaudone, Hyman M Scott, Tameika Scott, Elizabeth Ann Secord, Nathan Segall, William Seger, Shannen Seversen, Beverly E. Sha, Mitul Shah, Jinen Shah, Samira Shairi, Shivanjali Shankaran, Amie Shannon, Adrienne E. Shapiro, Stephan C. Sharp, Marian E. Shaw, Rozeli Shelly, Sandra Waller Shelton, Lawrence Sher, Amy C Sherman, Neil P. Sheth, Steven Shinn, Tammi L. Shlotzhauer, Kathryn Shoemaker, Timothy R. Shope, Bo Shopsin, STEVEN J. SHOPTAW, Rajeev Shrestha, Georgi Shukarev, Farhan Ahmed Siddiqui, Marc Siegel, Silva Sieger, Dianca Sierra, Abraham Mosigisi Siika, William P. Silver, Todd Simmons, Gary Leonard Simon, Matthew D. Sims, Léonard Singer, Chandramani Singh, Veer Bahadur Singh, Justin Singletary, Nuchra Sirisuphmitr, Stephanie Skipper, Stacy Slechta, Teresa S. Sligh, William Smith, Mary Smith, Derek M. Smith, Michael J. Smith, Katherine F. Smith, Candace J. Smith, Kimberly Snell, Mohammad Mahdee Sobhanie, Obiageli Sogbetun, Joel Solis, Cora Sonnier, Carrie Sopher, Adriana Sordo Duran, Brit Sovic, Stephen A. Spector, Steven M. Sperber, Bart Spiessens, Stephanie Sproule, Saranya Sridhar, Jonathan Staben, Jessica Stahl, Amber Stanford, Lisa Stangl, Ariana C. Stanton, Katherine Stapleton, Jack T. Stapleton, Thomas Starkey, Richard C. Starlin, Amy Starr, Ryan P. Starr, Kenneth Steil, Carolene Stephenson, Kathryn E. Stephenson, Lisa Stevens Rameaka, Brittany Stewart, Jeffrey J. Stoddard, Rob Striker, Frank Struyf, Suzanna Studdard, Laura Stulken, Mildred Stull, Rodney E. Sturgeon, May-Yin Suen, Danny H. Sugimoto, Amit Suresh Bhate, Janice Suyehira, Kazuo Suzuki, Shobha Swaminathan, Suzanne K. Swan, Edith M. Swann, Austin D. Swanson, Christy Sweet, Elisa Swieboda, Scott N. Syndergaard, Karla Beatriz Tafur Bances, Therese Takas, Zudi-Mwak Takizala, Simbarashe G. Takuva, Kawsar R. Talaat, Dipesh Tamrakar, Chen Sabrina Tan, Cayce Tangemen, Tamzin Tanner, Milagritos Tapia, Denis Tarakjian, Karen T. Tashima, David Tatelbaum, Fernanda Tavares Da-Silva, Edward M. Tavel, Kimberly L. Taylor, Brandie DePaoli Taylor, Barbara Sieck Taylor, David George Taylor, Sharita Tedder-Edwards, Meghan Teherani, Leslie M. Tharenos, Jeffrey Thessing, Meagan Thomas, LaTeshia Thomas-Seaton, Amy J. Thompson, Karl M. Thompson, Teri Thompson-Seim, Isaac P. Thomsen, Lucas Otieno Tina, Ramy J. Toma, Joanne E. Tomassini, Christian Tomaszewski, Lee Tomatsu, Ryan Tomlinson, Xiaomi Tong, Tina Tong, Juan Pablo Torres, Julián A. Torres, Dalia Tovar, Carolyn Tran, John Jay Treanor, Sade A. Tukuru, Christine B. Turley, Mark A. Turner, Stefanie Tyson, Akiyoshi Uchiyama, Robert J. Ulrich, Lisa S. Usdan, Gregory C. Utz, Timothy P. Vachris, Bruno Valenti, Insiya Valika, Mimi Van Der Leden, Ilse Van Dromme, Wesley Van Ever, Johan Van Hoof, Griet Van Roey, An Vandebosch, Sergio L. Vargas, Tilly A. Varughese, Eduardo Gabriel Vázquez Saldaña, Norma Vega, Karen Sofia Vega Orozco, Diana Vegas, Hector Velásquez, Michele Vertucci, Veronica Viar, Roberto A. Viau, Nicholas A. Viens, Tonya L. Villafana, Sandra M. Villagómez Martínez, M.C. Castro Villegas, Johan Vingerhoets, Mary A. Vogler, Mandy Vowell, Keith W. Vrbicky, Deo Wabwire, Larkin T. Wadsworth, Tami Wahlin, Anne Wajja, Phil Wakefield, Anna Wald, Shannon L. Walker, James Wallace Walker, Edward E. Walsh, Mary C. Walsh, Emmanuel B. Walter, Ayanna Walters, Tina J. Wang, Ashley Warden, T. Anh Wartel, Michael J. Waters, Breanz Watkins, Angella Webb, Hala Webster, Jessica L. Weidler, Thomas Weiss, Margaret Wells, Andrea Wendrow, Melody Werne, Whitney West, Jordan L. Whatley, Jennifer A. Whitaker, Julie J. White, Jewel J. White, Toni White, Priyantha N. Wijewardane, Timothy J. Wilkin, Bethanie E. Wilkinson, Samantha Williams, Barton G. Williams, Hayes Williams, Greg A. Wilson, C. D. Wilson, Natasha Wilson, Clint C. Wilson, Jennifer Winbigler, Peter J. Winkle, Patricia L. Winokur, John Witbeck, David Alain Wohl, Wayne Woo, Leana Woodside, Glenn Wortman, Yi H. Wu, Paul E. Wylie, Kinara S. Yang, Fan Yang, Anelgine C. Yoon, Jill A. York, Cheryl A. Young, Juan Luis Yrivarren Giorza, Joseph Stephen Yusin, Luz Marina Zapata, Zindy Yazmín Zárate Hinojosa, Rebecca Zash, Elodie Zaworski, Arthur L. Zemanek, Kate Zenlea, Karla Zepeda, Marcus Zervos, Nan Zhai, Kevin Matthew Zhang, Nianxian Zhang, James Zhou, Andrea J. Zimmer, Barry S. Zingman, Carmen Zorrilla

6Citations signalées, ce qui n’est pas une note de qualité
22Institutions déclarées
3Pays d’affiliation déclarés

Rattachement africain : us, gb, be. Niveau de preuve : code pays fourni par la source.

Le résumé fourni par la source

Importance: The test-negative design (TND) has been widely used to assess postmarketing COVID-19 vaccine effectiveness but requires further evaluation for this application. Objective: To determine whether the TND reliably evaluates vaccine effectiveness against symptomatic COVID-19 using placebo-controlled vaccine efficacy randomized clinical trials (RCTs). Design, Setting, and Participants: This secondary cross-protocol analysis constructed TND study datasets from study sites in 16 countries across 5 continents using the blinded phase cohorts of 5 harmonized phase 3 COVID-19 Prevention Network RCTs: COVE (Coronavirus Vaccine Efficacy and Safety), AZD1222, ENSEMBLE, PREVENT-19 (Prefusion Protein Subunit Vaccine Efficacy Novavax Trial COVID-19), and VAT00008. Participants included adults who received the intended number of doses, experienced COVID-19-like symptoms, and obtained SARS-CoV-2 testing. Start dates ranged from July 27, 2020, to October 19, 2021; data cutoff dates ranged from March 26, 2021, to March 15, 2022. Statistical analysis was performed from May 11, 2023, to February 25, 2025. Interventions: Participants received vaccines consisting of messenger RNA-1273 (COVE; 2 doses 28 days apart), ChAdOx1 nCoV-19 (AZD1222; 2 doses 28 days apart), Ad26.COV2.S (ENSEMBLE; 1 dose), NVX-CoV2373 (PREVENT-19; 2 doses 21 days apart), CoV2 preS dTM-AS03 (VAT00008; D614) (2 doses 21 days apart), or CoV2 preS dTM-AS03 (D614 plus B.1.351) (VAT00008; 2 doses 21 days apart) or placebo. Main Outcomes and Measures: Main outcomes were symptomatic COVID-19 according to each trial's primary efficacy definition and the Centers for Disease Control and Prevention definition. Vaccine effectiveness was estimated using targeted maximum likelihood estimation under a semiparametric logistic regression model and ordinary logistic regression. Noncase exchangeability, a core TND assumption for unbiased estimation, was also assessed by estimating vaccine efficacy against non-COVID-19 illness. Results: Among the 12 157 participants included in the analysis, mean (SD) age was 45 (15) years, 6414 were female (53%), 5858 were vaccinated (48%), 2835 experienced primary COVID-19 (23%), and 2992 experienced Centers for Disease Control and Prevention-defined COVID-19 (25%). TND vaccine effectiveness estimates were concordant with RCT vaccine efficacy estimates (concordance correlation coefficient, 0.86 [95% CI, 0.58-0.96] for both outcomes). The semiparametric method had 48% smaller variance estimates than ordinary logistic regression. Noncase exchangeability was generally supported with a median vaccine efficacy against non-COVID-19 illness of 7.7% (IQR, 2.7%-16.8%) across trial cohorts and most 95% CIs including 0. Conclusions and Relevance: 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.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.

Le contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref
Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data
Date Crossref
28/05/2025
Éditeur
American Medical Association (AMA)
Type
journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

Où se fait cette recherche

  • University of Washington pays non établi dans la notice
    Université ou école supérieure
  • Fred Hutch Cancer Center pays non établi dans la notice
    Organisation à but non lucratif
  • National Institutes of Health Fogarty International Center pays non établi dans la notice
    Organisme public
  • Fogarty International Center pays non établi dans la notice
    Établissement de santé
  • Florida State University pays non établi dans la notice
    Université ou école supérieure
  • Grady Memorial Hospital pays non établi dans la notice
    Établissement de santé
  • Emory University Department of Medicine pays non établi dans la notice
    Université ou école supérieure
  • Grady Health System pays non établi dans la notice
    Établissement de santé
  • Brigham and Women's Hospital Division of Infectious Diseases pays non établi dans la notice
    Établissement de santé
  • Columbia University pays non établi dans la notice
    Université ou école supérieure
  • New York Blood Center pays non établi dans la notice
    Organisation à but non lucratif
  • Baylor College of Medicine Department of Molecular Virology and Microbiology pays non établi dans la notice
    Université ou école supérieure

University of Washington, Fred Hutch Cancer Center et Fogarty International Center — National Institutes of Health, avec 9 autres affiliations.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

SARS-CoV-2 and COVID-19 Researchvaccines and immunoinformatics approachesImmune responses and vaccinations
Lire en accès ouvert Consulter la publication primaire Ouvrir le DOI

BNTIC News n’est pas le producteur de ces données. Les publications sont interrogées à la demande dans Crossref, OpenAIRE, DOAJ, Europe PMC, HAL, DataCite, AfricArXiv, ROR et la Banque mondiale, sans clé d’accès. OpenAlex reste optionnel. Aucun service payant n’est nécessaire et aucune donnée externe n’est enregistrée en base. Consulter les sources et leurs limites.