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

作者：Leah Andrews, M. Elizabeth Halloran, Kathleen M. Neuzil, Lars van der Laan, Yunda Huang, Jessica Andriesen, Mayur Patel, Leigh H. Fisher, Holly Janes, Nadine Rouphael, Stephen R. Walsh, Deborah Theodore, Hong‐Van Tieu, Magdalena E. Sobieszczyk, Hana M. El Sahly, Lindsey R. Baden, Ann R. Falsey, Thomas Campbell, Colleen F. Kelley, Catherine Healy, Lilly Cheng Immergluck, Benjamin J. Luft, Ian Hirsch, Guy de Bruyn, Carla Truyers, Frances Priddy, Kelsey M. Sumner, Brendan Flannery, Dean Follmann, Peter B. Gilbert, COVID-19 Prevention Network (CoVPN), Vanessa Abad, Karina Abalos, Getahun Abate, Anum Abbas, José Accini, Ronald Ackerman, Jamie Ackerman, Jeremy Ackermann, Atoya Adams, Michael Adams, Mark Adams, Michael R. Adams, Jeffrey Adelglass, Sarah Afework, Nina Ahmad, Christine Akamine, Julie A. Ake, Gary Albert, María L. Alcaide, Nathan L. Alderson, Lily Aleman, José O. Alemán, Mohamed Al‐Ibrahim, Mohammed Allaw, Leland N. Allen, Mary 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 P. Andrasik, Stephanie Andree, Jeb Andrews, Jessica Andriesen, 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 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 H. Bauer, José A. Bazan, María Gabriela Becerra, Cynthia Strout, Teresa Becker, David Beckmann, Roger Bedimo, Linda R. Belhorn, Genevieve Beninati, Jorge A. Benítez, David Benkeser, Annette R. Bennett, Elizabeth Bennett, Tatiana Beresnev, Aude Berge, Megan Berman, Maria I. Bermudez, Marcia Bernard, David I. Bernstein, Jennifer N. Berry, Andrea A. Berry, Vladimir Berthaud, Hanna Beyko, Kristin Bialobok, Joanne Billings, Oleksandra Bilotkach, Zachary S. Bittner, Jeanne Blevins, Jill Blumenthal, Rebecca Boas, Joseph A. Bocchini, Tyler D. Bold, Matthew Bonaparte, Alison Bondell, P. K. Bondy, Alberto Cadena Bonfanti, Judith Borger, Scott 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 Broder, Adam Brosz, David Browder, Lesley H. Browder, Jeremy Brown, Cynthia D. Brown, Robert Brownlee, Elizabeth Bruce, Susan Buchbinder, Cynthia Bueno, Elisabeth Bukusi, Delia Bullock, Catherine A. Bunce, Cortney Burch, Michelle L. Burgett, Abram H. Burgher, Larry M. Bush, Michael B. Butcher, Robert Buynak, L. Cade, Rafael Calderon, Richard Calderone, Amy Caldwell, Cornell Calinescu, Robert S. Call, Jim Callis, Laura Julia Camacho Choza, Andrés Camacho-González, Thomas B. Campbell, Wesley Campbell, Michael Cancilla, Kevin D. Cannon, Karina Cano Martínez, Richard Canter, Valeria D Cantos, Vicky Cárdenas, Martha Medina, Ellie Carmody, Christopher Carpenter, Melissa A. 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 Cavert, Médéric Celle, Jorge A. Chacón, Mesha M. Chadwick, Amy Chamberlain, Austin Chan, Jennifer 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 Chow, Lisa Chrisley, Shane G. Christensen, Laurence Chu, Hanh Chu, Waseem Chughtai, Michael Chung, Annie Ciambruschini, Cristina Cicogna, Alexander M. Clark, Jesse L. Clark, Phillip Claybrook, Andrea Clement, Lauren Clement, Steve Clemons, Heather Clouting, Lisa Cohen, Stuart H. Cohen, Jacob Coleman, Joseph P. Connor, James H. Conway, Erin Cooksey, Robert W. Coombs, Maureen Cooney, Deanna Cooper, Paul Coplan, Lawrence Corey, Raymond Cornelison, Barbara Corral, Jordan Coslet, Erin Coston, Michael J. Cotugno, Florence Coux, Jessica Cowden, Paul Cramer, C. Buddy Creech, Charnell Cromer, Marshall A. Cross, Aurelio Cruz-Valdéz, Marcel E. Curlin, LaKondria Curry, Jerome Custers, E. Cutz, Eric S. Daar, Michelle DallaPiazza, Dima Dandachi, Elizabeth Danford, Lyly Dang, Stephen R. Daniels, Chandan Krushna Das, Santa Kumar Das, Matthew 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 Rodríguez, Ian De Proost, Christopher Dedon, Jon F. Dedon, Teresa Deese, Emily Degan, Elliot DeHaan, Edwin DeJesus, Carlos del Rio, Michael S. Delgado, M. Delgado, Ernesto Delgado, David Dellaero, Weiping Deng, Douglas Denham, Chinar Desai, Parul Desai, Michaël Desjardins, Karen Deutsch, Michael Dever, Naomi Devine, Louis Devlin, Carlos A. DiazGranados, Secia Díaz-Miralrio, Michelle Dickey, David 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 Eckhardt, Frank Eder, Srilatha Edupuganti, Leslie A. Edwards, Mark Eickhoff, Hana M. El Sahly, Edward F. Ellerbeck, Grant Ellsworth, Elwaleed Elnagar, Victoria Engler, Kendra Enright, David J. Ensz, Sally Eppenbach, Sandra K. Erickson, Joseph Eron, Joseph J. Eron, Tiffany Esinhart, Claudia Espinosa, Luis Espinoza, Brandon Essink, Elizabeth Everette, Evan Ewers, Beverly Ewing, Amy Falk, Ann R. Falsey, Norberto Fas, Michael P. Fay, Szheckera Fearon, Brittany Feijoo, Gregory Feldman, Uriel R. Felsen, Hein Fennema, Carl J. Fichtenbaum, Tom Fiel, Carlos Fierro, Kenneth Finkelstein, Jon M. Finley, Suzanne Fiorillo, David Fitzpatrick, Diana F. Florescu, Patrick A. Flume, Charles Fogarty, Jennifer A. Foley, Dean Follmann, 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, G.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 Gharib, Suzanne Gharib, Richard Gibson, Peter B. Gilbert, Alfredo Gilberto Guerreros Benavides, Teletha Gipson, Eneyda Giuvanela Llerena Zegarra, Gregory M. Glenn, Richard Glover, Erin A. Goecker, Paul Goepfert, James N. Goldenberg, Blanca 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 Gottschlich, Melissa Gottschlich, Shanda Gower, Daniel S. Graciaa, Barney S. Graham, Irene Graham, Maria Angelica Granados, Amber Grant, Brett Gray, Glenda Gray, Roni Gray, S Green, Allison Green, Justin A. Green, Rusty Greene, Caroline Greene, Cathy Greiwe, Alexander L. Greninger, Carl Griffin, Marie-Hélène Grillet, Joseph A. Grillo, Beatriz Grinsztejn, Robert Grossberg, Nicole Grunenberg, Bernard Grunstra, Juan V. Guanira, Sonia Guerrero, Lea Guillery, Clint C. Guillory, Caitlin J. Guiney, Catherine Q. Gular, Shauna Gunaratne, Sanjay Gurunathan, Milton Haber, Greg Hachigian, Amina Z. Haggag, William O. Hahn, Evelyn Hall, Jessicalee Hall, David Halpert, Holli Hamilton, E. 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 Hatlen, Kirsten Hauge, Lynne A. Haughey, Michelle Haynes, Gary Headden, C. Mary Healy, Parke Hedges, Dirk Heerwegh, Theresa Hegmann, Jessica Heimonen, Destiny S. Heinzig-Cartwright, Sheryl L. Henderson, Jeffrey A. Henderson, Renea Henderson, Jenny Hendriks, Gayle D. Hennekes, Matthew J. Hepburn, Ramin S. Herati, Erica Herc, Will Hernandez, Laura Hernandez Guarin, Maria Hernandez Moran, Robin Hilder, John M. Hill, Janet E. Hill, Ian Hirsch, Ken Ho, Alejandro Hoberman, Daniel F. Hoft, Leila S Hojat, Troy Holdeman, Ripley R. Hollister, Lisa Holloway, Gregory Holt, Matthew Hong, Stephan Hong, Rosamond Hong, Amanda Horn, Manisha Horton, Gary Horwith, Sybil Hosek, Cyrus Hoseyni, Patty Howenstine, Yunda Huang, Ying Huang, Kathy Hudzina, Cory J. Huffine, Esther S. Huffine, Christine 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, Lilly Cheng Immergluck, Dilek İnce, Sarah M. Ingalsbe-Geno, Asha Inniss, Farah Irani, M. Majumder, Ryan Israelsen, Leslie 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, Holly Janes, Melanie Jay, Robert Jeanfreau, Susan Jeanfreau, Will Jennings, Natasa Jenson, Keith R. Jerome, Jennifer Johnson, John L. Johnson, Danyel Johnson, Diane Johnson, Marı́a Cecilia Johnson, Lisa Johnson, Erica L. Johnson, Kristen Johnson, Jennie Johnson, Carrie D. Johnston, William P. Jones, Kathleen S. Jones, Edward C. Jones‐López, B. Jordan, Michal Juraska, Jarek Juraszek, Jessica Justman, Seyram Kaali, Scott Kahney, Spyros A. Kalams, Satoshi Kamidani, Sheetal Kandiah, Pamela Kane, Piush Kanodia, Shashi N. Kapadia, Lois Katz, Melinda Katz, Carol A. Kauffman, Daniel Kaul, Margaret Kautz, Westly Keating, Jia Jin Kee, Michael C. Keefer, Wendy A. Keitel, Colleen F. Kelley, Amy S. Kelley, Kary Kelly, Elizabeth J. Kelly, Sandra Kelman, Gerald Kelty, Ashley Kennedy, C Kennelly, Maryam Keshtkar‐Jahromi, Jill Kessler, Nzeera Ketter, Najat Khan, Nitin Khandelwal, Shishir Khetan, Saadia Khizer, Hannah Kibuuka, Kristen Kiersey, Paul E. Kilgore, Anthony Kim, Kami Kim, Murray Kimmel, Michelle King, Jeffrey K. Kingsley, William C. Kirby, John A. Kirby, Beth D. Kirkpatrick, Judith L. Kirstein, Cissy Kityo Mutuluuza, Noah Kiwanuka, Francis Kiweewa, John S. Kizer, Terry D. Klein, Thomas Klein, Tracy Klein, Jeffrey A. 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 Laguio‐Vila, Sherry Lamberth, Raphael J. Landovitz, Dakotah C. Lane, Thelma Laot, Anyela Lara, Matthew B. Laurens, Andrew Lauria, Daniel T. Lawler, Nga Le, Mathieu Le Gars, Vickie Leathers, Brett Leav, Logan Ledbetter, Julie E. Ledgerwood, Kia Lee, Jessica L. Lee, Marina Lee, Angela Lee, Mark Leibowitz, Natalia Leistner, Mark Lerman, Michael Levin, Brendan Levy, Phillip D. Levy, Wendell Lewis, Michael Lewis, Derek Lewis, Wendell 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 S. Lord, J. E. J. Lovell, Ronald Lubelchek, John Lucaj, Njira Lugogo, Gary J. Luckasen, Gregg Lucksinger, Annie Luetkemeyer, Benjamin J. Luft, Rafael Lupercio, Alisha Lutat, Jill Maaske, Rosa MacBryde, Nolan Mackey, Rebecca Pellett Madan, Janine Maenza, Siham Mahgoub, Mamodikoe Makhene, Hussain Malbari, Elissa Malkin, Carlos Malvestutto, Stephanie Mamod, Millie Manalo, Jose Castillo Mancilla, Kishorchandra 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, Catherine Healy, John R. Mascola, Robín Masón, Roger Masotti, Paul Matherne, Christopher Matich, Monica Mauri, Ryan C. Maves, Michelle Maxwell, Celia Maxwell, Kenneth H. Mayer, Monica A. McArthur, Jennifer McCarter, Michael J. McCartney, R. Scott McClelland, Bruce McClenathan, Rachael McClennen, Andrew McConnell, Margaret McCort, M. Juliana McElrath, Charlene McEvoy, Alice McGarry, John McGettigan, Jonlyn McGettigan, Lora J. McGill, Eric McGrath, Mark M. McKenzie, Cecilia McKeown-Bragas, Irene McKnight, Morgan McLaughlin, Meredith McNairy, Kelly McQuarrie, Andrew McWilliams, Jodi Meck, Surisday Mederos, Amy Medina, Carmen Medina, Jeffery L. Meier, Thomas A. Mellman, Jessica M. Mena, Lisa Menard, Kathleen Menasche, Janet Méndez, Jorge F. Méndez Galván, Rafael Mendoza‐Meroño, Erika Mendoza, Sandra Mendoza, Rajan Merchant, Fernando L. Merino, David Metzger, Jay Meyer, Robert Meyer, Eric A. Meyerowitz, Nelson L. Michael, Randle Middleton, Maria D. Mileno, Matthew Miles, Chelsea Miles, Eric N. Miller, Jacqueline M. Miller, Vicki E. Miller, Meagan Miller, Paulina Miller, J. Milligan, Ann Marie Milliken, Jill E. Miracle, Vincent Mirkil, Mehdi Mirsaeidi, C.L. Mitchell, Kazuyuki Mizuyama, Gowdhami Mohan, Satyajit Mohapatra, Sharzhaad Molina Guizar, Florence Momplaisir, Cynthia L. Monaco, Cynthia Montano-Pereira, Natasha Montoya, Candice Montros, Amaran Moodley, Fernanda Morales Berstein, Caitlin A. Moran, Catherine Moreau, Stephen Morris, Victoria Mosteller, Stefanie Mott, Connie Moya, T. H. Moye, Kimberly D. Mueller, Nancy B. Mueller, Jacqueline Muenzner, Nelly Mugo, Sauda Muhammad, Kathleen M. Mullane, Mark J. Mulligan, Gysella Muñiz, 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, Kathleen Neuzil, Hannah Nevarez, Joseph L. Newberg, Lauren Newhouse, Patrick Newingham, Fred E. Newton, Lucy Ng-Price, Kimberly Nieves, Chimeremma 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 Okech, Tracy Okonya, Jason F. Okulicz, Oyebisi Olanrewaju, Shelby Olds, Marcia O’Leary, Patrick A. Oliver, Odette Olivieri, Jocelyn Zuleica Olmos Vega, Sarah Omodele, Allie Oplinger, Emily Oppenheim, Yaa Oppong, Jessica Ortega, Sandra Janeth Ortega Domínguez, Maricruz E. Ortegón, Masaru Oshita, Erica Osmundsen, Jaleh Ostovar, Quito Osuna Carr, María Calado Otero, Janet Otto, Samuel Gurrion Ouma, Jeffrey S. Overcash, Temitope Oyedele, Janet Oyieko, Janeth Pacheco-Flores, Carmen A. Paez, Barbara 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 Parikh, Elizabeth Parker, Susan Parker, Kevin Parks, Reza Parungao, Alpa V. Patel, Priti Patel, Thomas L. Patterson, Jan E. Patterson, Walter Patton, Leena Paul, Corrina Pavetto, J. Pavie, James E. Peacock, Michele Peake-Andrasik, Laura Pearlman, Alyssa-Kay Peay, David Pekala, Alison 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 S. Pinilla, Simmy Pinto, Rebecca Pitotti, David Pitrak, April Pixler, Stanford Plavin, Laura Polakowski, Terry L. Poling, Philip Ponce, Laura Porterfield, Svitlana Postol, Amy Potts, Richard Powell, Margaret V. Powers‐Fletcher, E. Javier Pretell Alva, Patty Price-Abbott, Veronica Procasky, John 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 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, S Richmond, Sharon A. Riddler, Robert Riesenberg, Dolores Rijos, Joshua Rindt, Enrique Rivas, Juan J. Rivera, María I. Rivera, Juana Rivera, Gina Rivero, Rafael Rivero, Zainab Rizvi, Barbara Rizzardi, Denise Roadman, Merlin L. Robb, Afsoon Roberts, Toni Robinson, Dawn Robison, Elizabeth E. Robison, Shannon Rodman, Jessica Rodriguez, Carina A. Rodriguez, Edith Rodriguez, Rachel Rokser, Charlotte-Paige Rolle, Stephanie Rolsma, Peter Ronco, Melody Ronk, Adam B. Rosen, Jeffrey B. Rosen, David Rosenberg, A. Lina Rosengren, Christiana A. Rostad, Joan Rothenberg, Rambod Rouhbakhsh, Nadine Rouphael, Crystal Rowell, Pavitra Roychoudhury, Rola G. Rucker, Mónica Vallejo Ruiz, Vida Veronica Ruiz Herrera, Javier Ruiz‐Guiñazú, Guillermo M. Ruiz‐Palacios, Karen Ruperto, Richard Rupp, Sarah E. Rutstein, Natasha Rybak, Martin Ryser, Jerald Sadoff, Michelle Saemann, Beth Safirstein, Nafisa Saleem, Jamshid Saleh, Mansoor N. Saleh, Kacie Sales, Amy Salzl, Denise Sample, Robert J. Samuels, Rosario Sánchez, Martha Sanchez, Erica L. Sanchez, Pedro L. Sánchez, Laura 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, F. Schödel, Debra B. Schroeck, Lode Schuerman, Hanneke Schuitemaker, Howard I. Schwartz, Adam J. Schwartz, Howard Schwartz, Jennifer Schwartz, Tiffany Schwasinger‐Schmidt, Michael Sciaudone, Hyman Scott, Tameika Scott, Elizabeth 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 Sheth, Steven Shinn, Tammi Shlotzhauer, Kathryn Shoemaker, Timothy R. Shope, Bo Shopsin, Steven Shoptaw, Rajeev Shrestha, Georgi Shukarev, Farhan Siddiqui, Marc Siegel, Silva Sieger, Dianca Sierra, Abraham Siika, William P. Silver, Todd Simmons, Gary L. Simon, Matthew 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 Smith, Candace Smith, Kimberly Snell, Mohammad Mahdee Sobhanie, Magdalena E. Sobieszczyk, 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 Starlin, Amy Starr, Ryan P. Starr, Kenneth Steil, Carolene Stephenson, Kathryn E. Stephenson, Stephanie Sterling, 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 Sugimoto, Amit Suresh Bhate, Janice Suyehira, Kazuo Suzuki, Shobha Swaminathan, Suzanne K. Swan, Edith Swann, Austin D. Swanson, Christy Sweet, Elisa Swieboda, Scott N. Syndergaard, Karla Beatriz Tafur Bances, Therese Takas, Zudi-Mwak Takizala, Simbarashe 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 Tavel, Kimberly L. Taylor, Brandie D. Taylor, Barbara S. Taylor, David G. Taylor, Sharita Tedder-Edwards, Meghan Teherani, Leslie Tharenos, Jeffrey Thessing, Meagan Thomas, LaTeshia Thomas-Seaton, Amy Thompson, Karl M. Thompson, Teri Thompson-Seim, Isaac Thomsen, Hong‐Van Tieu, 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 J. Treanor, Carla Truyers, Sade Tukuru, Christine B. Turley, Mark Turner, Stefanie Tyson, Akiyoshi Uchiyama, Robert J. Ulrich, Lisa Usdan, Gregory 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 Varughese, Eduardo Gabriel Vázquez Saldaña, Norma Vega, Karen Sofia Vega Orozco, Diana Vegas, Hector Velásquez, Michele Vertucci, Veronica Viar, Roberto Viau, Nicholas A. Viens, Tonya Villafana, Sandra M. Villagómez Martínez, M.C. Castro Villegas, Johan Vingerhoets, Mary Vogler, Mandy Vowell, Keith Vrbicky, Deo Wabwire, Larkin T. Wadsworth, Tami Wahlin, Anne Wajja, Phil Wakefield, Anna Wald, Shannon L. Walker, James Walker, Stephen R. Walsh, Edward E. Walsh, Mary C. Walsh, Emmanuel B. Walter, Ayanna Walters, Tina 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 White, Jewel J. White, Toni White, Priyantha N. Wijewardane, Timothy Wilkin, Bethanie Wilkinson, Samantha Williams, Barton G. Williams, Hayes Williams, Greg Wilson, C. D. Wilson, Natasha Wilson, Clint C. Wilson, Jennifer Winbigler, Peter Winkle, Patricia Winokur, John Witbeck, David A. Wohl, Wayne Woo, Leana Woodside, Glenn Wortman, Yi H. Wu, Paul E. Wylie, Kinara S. Yang, Fan Yang, Anelgine C. Yoon, Jill York, Cheryl Young, Juan Luis Yrivarren Giorza, Joseph Yusin, Luz Marina Zapata, Zindy Yazmín Zárate Hinojosa, Rebecca Zash, Elodie Zaworski, Arthur L. Zemanek, Kate Zenlea, Karla Zepeda, Marcus Zervos, Nan Zhai, K Zhang, Nianxian Zhang, Honghong Zhou, James Zhou, Andrea Zimmer, Barry S. Zingman, Carmen Zorrilla · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2025.12763 · 被引用次数：6 · 研究领域：SARS-CoV-2 and COVID-19 Research、vaccines and immunoinformatics approaches、Immune responses and vaccinations

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....