SARS-CoV-2 Viral Load in the Nasopharynx at Time of First Infection Among Unvaccinated Individuals
Authors: Leigh H. Fisher, Jia Jin Kee, Albert Liu, Claudia M. Espinosa, April K. Randhawa, James Ludwig, Craig A. Magaret, Samuel T. Robinson, Peter B. Gilbert, Ollivier Hyrien, James G. Kublin, Nadine Rouphael, Ann R. Falsey, Magdalena E. Sobieszczyk, Hana M. El Sahly, Beatriz Grinsztejn, Glenda E. Gray, Karen L. Kotloff, Cynthia L. Gay, Brett Leav, Ian Hirsch, Frank Struyf, Lisa M. Dunkle, Kathleen M. Neuzil, Lawrence Corey, Yunda Huang, Paul A. Goepfert, Stephen R. Walsh, Lindsey R. Baden, Holly Janes, Atoya Adams, Eric Miller, Bruce G. Rankin, Steven Shinn, Dean Follmann, Jacqueline Miller, Jerald Sadoff, Marshall Nash, Sinikka L. Green, Colleen Jacobsen, Jayasree Krishnankutty, Sikhongi Phungwayo, Richard M. Glover, Stacy Slechta, Troy Holdeman, Robyn Hartvickson, Amber Grant, Terry L. Poling, Terry D. Klein, Thomas C. Klein, Tracy R. Klein, William B. Smith, Richard L. Gibson, Jennifer Winbigler, Elizabeth Parker, Priyantha N. Wijewardane, Eric Bravo, Jeffrey Thessing, Michelle Maxwell, Amanda Horn, Catherine Mary Healy, Christine Akamine, Laurence Chu, R. Michelle Chouteau, Michael J. Cotugno, George H. Bauer, Greg Hachigian, Masaru Oshita, Michael Cancilla, Kristen Kiersey, William Seger, Mohammed Antwi, Allison Green, Anthony Kim, Michael Desjardins, Jennifer A. Johnson, Amy Sherman, Judith Borger, Nafisa Saleem, Joel Solis, Martha Carmen Medina, Westly Keating, Edgar Garcia, Cynthia Bueno, Nathan Segall, Douglas S. Denham, Thomas Weiss, Ayoade Avworo, Parke Hedges, Cynthia Becher Strout, Rica Santiago, Yvonne Davis, Patty Howenstine, Alison Bondell, Kristin Marks, Tina Wang, Timothy Wilkin, Mary Vogler, Carrie Johnston, Michele P. Andrasik, Jessica G. Andriesen, Gail Broder, Niles Eaton, Huub G. Gelderblom, Rachael McClennen, Nelson Michael, Merlin Robb, Carrie Sopher, Vicki E. Miller, Fredric Santiago, Blanca Gomez, Insiya Valika, Amy Starr, Valeria D. Cantos, Sheetal Kandiah, Carlos del Rio, Srilatha Edupuganti, Daniel S. Graciaa, Evan J. Anderson, Andres Camacho-Gonzalez, Satoshi Kamidani, Christiana A. Rostad, Meghan Teherani, David J. Diemert, Elissa Malkin, Marc Siegel, Afsoon Roberts, Gary Simon, Bindu Balani, Carolene Stephenson, Steven Sperber, Cristina Cicogna, Marcus J. Zervos, Paul Kilgore, Mayur Ramesh, Erica Herc, Kate Zenlea, Abram Burgher, Ann M. Milliken, Joseph D. Davis, Brendan Levy, Sandra Kelman, Matthew W. Doust, Denise Sample, Sandra Erickson, Shane G. Christensen, Christopher Matich, James Longe, John Witbeck, James T. Peterson, Alexander Clark, Gerald Kelty, Issac Pena-Renteria, Michael J. Koren, Darlene Bartilucci, Alpa Patel, Carolyn Tran, Christina Kennelly, Robert Brownlee, Jacob Coleman, Hala Webster, Carlos A. Fierro, Natalia Leistner, Amy Thompson, Celia Gonzalez, Lisa A Jackson, Janice Suyehira, Milton Haber, Maria M. Regalado, Veronica Procasky, Alisha Lutat, Carl P. Griffin, Ripley R. Hollister, Jeremy Brown, Melody Ronk, Wayne L. Harper, Lisa Cohen, Lynn Eckert, Matthew Hong, Rambod Rouhbakhsh, Elizabeth Danford, John Johnson, Richard Calderone, Shishir K. Khetan, Oyebisi Olanrewaju, Nan Zhai, Kimberly Nieves, Allison O'Brien, Paul S Bradley, Amanda Lilienthal, Jim Callis, Adam B Brosz, Andrea Clement, Whitney West, Luke Friesen, Paul Cramer, Frank S Eder, Ryan Little, Victoria Engler, Heather Rattenbury-Shaw, David J. Ensz, Allie Oplinger, Brandon J. Essink, Jay Meyer, Frederick Raiser, Kimberly Mueller, Keith W. Vrbicky, Charles Harper, Chelsie Nutsch, Wendell Lewis, Cathy Laflan, Jordan L. Whatley, Nicole Harrell, Amie Shannon, Crystal Rowell, Christopher Dedon, Mamodikoe Makhene, Gregory M. Gottschlich, Kate Harden, Melissa Gottschlich, Mary Smith, Richard Powell, Murray A. Kimmel, Simmy Pinto, Timothy P. Vachris, Mark Hutchens, Stephen Daniels, Margaret Wells, Mimi Van Der Leden, Peta-Gay Jackson-Booth, Mira Baron, Pamela Kane, Shannen Seversen, Mara Kryvicky, Julia Lord, Jamshid Saleh, Matthew Miles, Rafael Lupercio, John W. McGettigan, Walter Patton, Riemke Brakema, Karin Choquette, Jonlyn McGettigan, Judith L. Kirstein, Marcia Bernard, Mary Beth Manning, Joan Rothenberg, Toby Briskin, Denise Roadman, Sharita Tedder-Edwards, Howard I. Schwartz, Surisday Mederos, Shobha Swaminathan, Amesika Nyaku, Tilly Varughese, Michelle DallaPiazza, Sharon E. Frey, Irene Graham, Getahun Abate, Daniel Hoft, Leland N. Allen, Leslie A. Edwards, William S. Davis, Jessica M. Mena, Mark E. Kutner, Jorge Caso, Maria Hernandez Moran, Marianela Carvajal, Janet Mendez, Larkin T. Wadsworth, Michael R. Adams, Leslie Iverson, Joseph L. Newberg, Laura Pearlman, Paul J. Nugent, Michele D. Reynolds, Jennifer Bashour, Robert Schmidt, Neil P. Sheth, Kenneth Steil, Ramy J. Toma, William Kirby, Pink Folmar, Samantha Williams, Paul Pickrell, Stefanie Mott, Carol Ann Linebarger, Hussain Malbari, David Pampe, Veronica G. Fragoso, Lisa Holloway, Cecilia McKeown-Bragas, Teresa Becker, Barton G. Williams, William H. Jones, Jesse L. Clark, Steven Shoptaw, Michele Vertucci, Will Hernandez, Stephen A. Spector, Amaran Moodley, Jill Blumenthal, Lisa Stangl, Karen Deutsch, Kathleen M. Mullane, David Pitrak, Cheryl Nuss, Judy Pi, Carl Fichtenbaum, Margaret Powers-Fletcher, Michelle Saemann, Sharon Kohrs, Thomas B. Campbell, Andrew Lauria, Jose C. Mancilla, Hillary Dunlevy, Richard M. Novak, Andrea Wendrow, Scott Borgetti, Ben Ladner, Matthew Laurens, Lisa Chrisley, Cheryl Young, Susanne Doblecki-Lewis, Maria L. Alcaide, Jose Gonzales-Zamora, Stephen Morris, David Wohl, Joseph Eron, Ian Frank, Debora Dunbar, David Metzger, Florence Momplaisir, Judith Martin, Alejandro Hoberman, Timothy Shope, Gysella Muniz, Richard Rupp, Amber Stanford, Megan Berman, Laura Porterfield, Michael Lewis, Elham Ghadishah, Joseph Yusin, Mai Pham, Clarence B. Creech, Shannon Walker, Stephanie Rolsma, Robert Samuels, Isaac Thomsen, Spyros A. Kalams, Greg Wilson, Gregg H. Lucksinger, Kevin Parks, Ryan Israelsen, Jaleh Ostovar, Kary Kelly, Jeffrey S. Overcash, Hanh Chu, Kia Lee, Luis I. De La Cruz, Steve Clemons, Elizabeth Everette, Suzanna Studdard, Gowdhami Mohan, Stefanie Tyson, Alyssa-Kay Peay, Danyel Johnson, Gregory J. Feldman, May-Yin Suen, Jacqueline Muenzner, Joseph Boscia, Farhan Siddiqui, John Sanders, James Peacock, Julio Nasim, Michael L. Levin, Julie Hussey, Marcy Kulic, Mark M. McKenzie, Teresa Deese, Erica Osmundsen, Christy Sweet, Valentine M. Ebuh, Elwaleed Elnagar, Georgette Ebuh, Genevieve Iwuala, Laurie J. Han-Conrad, Todd Simmons, Denis Tarakjian, Jeremy Ackermann, Mark S. Adams, José O. Alemán, Mohamed S. Al-Ibrahim, David R. Andes, Jeb Andrews, Roberto C. Arduino, Martín Bäcker, Diana Badillo, Emma Bainbridge, Teresa A. Batteiger, Jose A. Bazan, Roger J. Bedimo, Jorge A. Benitez, Annette R. Bennett, David I. Bernstein, Kristin Bialobok, Rebecca Boas, Judith Brady, Angela R. Branche, Cynthia Brown, Catherine A. Bunce, Robert S. Call, Wesley Campbell, Ellie Carmody, Christopher Carpenter, Steven E. Carsons, Marvin Castellon, Mario Castro, Hannah Catan, Jennifer Chang, Mouna G. Chebib, Corey M. Chen, Margaret Cheng, Brian D. W. Chow, Annie Ciambruschini, Joseph P. Connor, James H. Conway, Maureen Cooney, Marcel Curlin, Claudia De La Matta Rodriguez, Jon F. Dedon, Emily Degan, Michelle Dickey, Craig Dietz, Jennifer L Dong, Brenda Dorcely, Michael P. Dube, Carmel B. Dyer, Benjamin Eckhardt, Edward Ellerbeck, Evan C. Ewers, Amy Falk, Brittany Feijoo, Uriel R. Felsen, Tom Fiel, David Fitz-Patrick, Charles M. Fogarty, Stacy Ford, Lina M. Forero, Elizabeth Formentini, Doris Franco-Vitteri, Robert W. Frenck, Elie Gharib, Suzanne Gharib, Rola G. Rucker, James N. Goldenberg, Luis H. González, Brett Gray, Rusty Greene, Robert M. Grossberg, Juan V. Guanira-Carranza, Alfredo Gilberto Guerreros Benavides, Clint C. Guillory, Shauna H. Gunaratne, David Halpert, Holli Hamilton, William R. Hartman, Timothy J. Hatlen, Sheryl L. Henderson, Ramin Herati, Laura Hernandez Guarin, Robin Hilder, Ken Ho, Leila Hojat, Sybil G. Hosek, Jeffrey M. Jacobson, Melanie Jay, Diane H. Johnson, Kathleen S. Jones, Edward C. Jones-López, Jessica E. Justman, Scott Kahney, Lois Katz, Melinda Katz, Daniel Kaul, Michael C. Keefer, Ashley Kennedy, Jennifer Knishinsky, Laura Kogelman, Susan L. Koletar, Angelica Kottkamp, Maryrose Laguio-Vila, Raphael J. Landovitz, Jessica L. Lee, Eneyda Giuvanela Llerena Zegarra, Anna S. Lok, James Lovell, Ronald Lubelchek, John Lucaj, Gary Luckasen, Annie Luetkemeyer, Njira Lucia Lugogo, Janine Maenza, Carlos Malvestutto, Monica Mauri, Ryan C. Maves, Kenneth H. Mayer, Michael J. McCartney, Margaret E. McCort, M. Juliana McElrath, Meredith McNairy, Fernando L. Merino, Eric A. Meyerowitz, Carol L. Mitchell, Cynthia L. Monaco, Sauda Muhammad, Sigridh Muñoz-Gómez, Sonal Munsiff, Paul Nee, Nicole L. Nollen, Asif Noor, Claudio Nuñez Lagos, Jason F. Okulicz, Patrick A. Oliver, Jessica Ortega, Steven Palmer, Lalitha Parameswaran, Purvi Parikh, Susan Parker, Reza Parungao, Juana R. Pavie, Rebecca P. Madan, Henry Peralta, Jennifer Petts, Kristen K. Pierce, E. Javier Pretell Alva, Lawrence J. Purpura, Vanessa Raabe, Sergio E. Recuenco, Tamara Richards, Sharon A. Riddler, Barbara Rizzardi, Rachel Rokser, Charlotte-Paige Rolle, Adam Rosen, Jeffrey Rosen, Lena R. Freese, María E. Santolaya, Linda M. Schipani, Adam Schwartz, Tiffany Schwasinger-Schmidt, Hyman Scott, Beverly E. 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Matherne, Amy Caldwell, Jessica Stahl, Mandy Vowell, Lauren Newhouse, Vladimir Berthaud, Zudi-Mwak Takizala, Genevieve Beninati, Kimberly Snell, Sherrie Baker, James Walker, Tavane Harrison, Meagan Miller, Janet Otto, Roni Gray, Christine Wilson, Tiffany Nemecek, Hannah Harrington, Sally Eppenbach, Wendell Lewis, Tana Bourgeois, Lyndsea Folsom, Gregory Holt, Mehdi Mirsaeidi, Rafael Calderon, Paola Lichtenberger, Jalima Quintero, Becky Martinez, Lilly Immergluck, Erica Johnson, Austin Chan, Norberto Fas, LaTeshia Thomas-Seaton, Saadia Khizer, Jonathan Staben, Tatiana Beresnev, Maryam Jahromi, Mary A. Marovich, Julia Hutter, Martha Nason, Julie Ledgerwood, John Mascola, Mark Leibowitz, Fernanda Morales, Mike Delgado, Rosario Sanchez, Norma Vega, Germán Áñez, Gary Albert, Erin Coston, Chinar Desai, Haoua Dunbar, Mark Eickhoff, Jenina Garcia, Margaret Kautz, Angela Lee, Maggie Lewis, Alice McGarry, Irene McKnight, Joy Nelson, Patrick Newingham, Patty Price-Abbott, Patty Reed, Diana Vegas, Bethanie Wilkinson, Katherine Smith, Wayne Woo, Iksung Cho, Gregory M. Glenn, Filip Dubovsky, David L. Fried, Lynne A. Haughey, Ariana C. Stanton, Lisa Stevens Rameaka, David Rosenberg, Lee Tomatsu, Viviana Gonzalez, Millie Manalo, Bernard Grunstra, Donald Quinn, Phillip Claybrook, Shelby Olds, Amy Dye, Kevin D. Cannon, Mesha M. Chadwick, Bailey Jordan, Morgan Hussey, Hannah Nevarez, Colleen F. Kelley, Michael Chung, Caitlin Moran, Paulina Rebolledo, Christina Bacher, Elizabeth Barranco-Santana, Jessica Rodriguez, Rafael Mendoza, Karen Ruperto, Odette Olivieri, Enrique Ocaña, Paul E. Wylie, Renea Henderson, Natasa Jenson, Fan Yang, Amy Kelley, Kenneth Finkelstein, David Beckmann, Tanya Hutchins, Sebastian Garcia Escallon, Kristen Johnson, Teresa S. Sligh, Parul Desai, Vincent Huynh, Carlos Lopez, Erika Mendoza, Jeffrey Adelglass, Jerome G. Naifeh, Kristine J. Kucera, Waseem Chughtai, Shireen H. Jaffer, Matthew G. Davis, Jennifer Foley, Michelle L. Burgett, Tammi L. Shlotzhauer, Sarah M. Ingalsbe-Geno, Daniel Duncanson, Kelly Kush, Lori Nesbitt, Cora Sonnier, Jennifer McCarter, Michael B. Butcher, James Fry, Donna Percy, Karen Freudemann, Bruce C. Gebhardt, Padma N. Mangu, Debra B. Schroeck, Rajesh K. Davit, Gayle D. Hennekes, Benjamin J. Luft, Melissa Carr, Sharon Nachman, Alison Pellecchia, Candace Smith, Bruno Valenti, Maria I. Bermudez, Noris Peraita, Ernesto Delgado, Alicia Arrazcaeta, Natalie Ramirez, Carmen Amador, Horacio Marafioti, Lyly Dang, Lauren Clement, Jennifer Berry, Mohammed Allaw, Georgettea Geuss, Chelsea Miles, Zachary Bittner, Melody Werne, Cornell Calinescu, Shannon Rodman, Joshua Rindt, Erin Cooksey, Kristina Harrison, Deanna Cooper, Manisha Horton, Amanda Philyaw, William Jennings, Hilario Alvarado, Michele Baka, Malina Regalado, Linda Murray, Sherif Naguib, Justin Singletary, Sha-Wanda Richmond, Sarah Omodele, Emily Oppenheim, Reuben Martinez, Victoria Andriulis, Leonard Singer, Jeanne Blevins, Meagan Thomas, Christine Hull, Isabel Pereira, Gina Rivero, Tracy Okonya, Frances Downing, Paulina Miller, Margaret Rhee, Katherine Stapleton, Jeffrey Klein, Rosamond Hong, Suzanne Swan, Tami Wahlin, Elizabeth Bennett, Amy Salzl, Sharine Phan, Jewel J. White, Amanda Occhino, Ruth Paiano, Morgan McLaughlin, Elisa Swieboda, Veronica Garcia-Fragoso, Maria G. Becerra, Toni White, Christine B. Turley, Andrew McWilliams, Tiffany Esinhart, Natasha Montoya, Shamika Huskey, Leena Paul, Karen Tashima, Jennie Johnson, Marguerite Neill, Martha Sanchez, Natasha Rybak, Maria Mileno, Stuart H. Cohen, Monica Ruiz, Dean M. Boswell, Elizabeth E. Robison, Trina L. Reynolds, Sonja Neumeister, Carmen D. Zorrilla, Juana Rivera, Jessica Ibarra, Iris García, Dianca Sierra, Wanda Ramon, Suzanne Fiorillo, Rebecca Pitotti, Victoria R. Anderson, Jose Castillo Mancilla, Nga Le, Patricia L. Winokur, Dilek Ince, Theresa Hegmann, Jeffrey Meier, Jack Stapleton, Laura Stulken, Monica McArthur, Andrea Berry, Milagritos Tapia, Elizabeth Hammershaimb, Toni Robinson, Rosa MacBryde, Susan Kline, Joanne L. Billings, Winston Cavert, Les B. Forgosh, Timothy W. Schacker, Tyler D. Bold, Dima Dandachi, Taylor Nelson, Andres Bran, Grant Geiger, S. Hasan Naqvi, Diana F. Florescu, Richard Starlin, David Kline, Andrea Zimmer, Anum Abbas, Natasha Wilson, Joseph J. Eron, Michael Sciaudone, A. Lina Rosengren, John S. Kizer, Sarah E. Rutstein, Carina A. Rodriguez, Elizabeth Bruce, Lisa J. Sanders, Kami Kim, Denise Casey, Barbara S. Taylor, Thomas Patterson, Ruth S. Pinilla, Delia Bullock, Philip Ponce, Jan Patterson, R. Scott McClelland, Dakotah C. Lane, Anna Wald, Frank James, Elizabeth Duke, Kirsten Hauge, Jessica Heimonen, Erin A. Goecker, Youyi Fong, Carol Kauffman, Kathleen Linder, Kimberly Nofz, Andrew McConnell, Robert J. Buynak, Angella Webb, Taryn Petty, Stephanie Andree, Erica Sanchez, Nolan Mackey, Clarisse Baudelaire, Sarah Dzigiel, Adrienna Marquez, Kim Quillin, Michelle King, Vanessa Abad, Jennifer Knowles, Michael Waters, Karla Zepeda, Jordan Coslet, Dalia Tovar, Marian E. Shaw, Mark A. Turner, Cory J. Huffine, Esther S. Huffine, Julie A. Ake, Elizabeth Secord, Eric McGrath, Phillip Levy, Brittany Stewart, Charnell Cromer, Ayanna Walters, Grant Ellsworth, Caroline Greene, Sarah Galloway, Shashi Kapadia, Elliot DeHaan, Clint Wilson, Jason Milligan, Danielle Raley, Joseph Bocchini, Bruce McClenathan, Mary Hussain, Evelyn Lomasney, Evelyn Hall, Sherry Lamberth, Christy Schmeck, Vickie Leathers
Journal: JAMA Network Open (2024)

Importance SARS-CoV-2 viral load (VL) in the nasopharynx is difficult to quantify and standardize across settings, but it may inform transmission potential and disease severity. Objective To characterize VL at COVID-19 diagnosis among previously uninfected and unvaccinated individuals by evaluating the association of demographic and clinical characteristics, viral variant, and trial with VL, as well as the ability of VL to predict severe disease. Design, Setting, and Participants This secondary cross-protocol analysis used individual-level data from placebo recipients from 4 harmonized, phase 3 COVID-19 vaccine efficacy trials sponsored by Moderna, AstraZeneca, Janssen, and Novavax. Participants were SARS-CoV-2 negative at baseline and acquired COVID-19 during the blinded phase of the trials. The setting included the US, Brazil, South Africa, Colombia, Argentina, Peru, Chile, and Mexico; start dates were July 27, 2020, to December 27, 2020; data cutoff dates were March 26, 2021, to July 30, 2021. Statistical analysis was performed from November 2022 to June 2023. Main Outcomes and Measures Linear regression was used to assess the association of demographic and clinical characteristics, viral variant, and trial with polymerase chain reaction–measured log 10 VL in nasal and/or nasopharyngeal swabs taken at the time of COVID-19 diagnosis. Results Among 1667 participants studied (886 [53.1%] male; 995 [59.7%] enrolled in the US; mean [SD] age, 46.7 [14.7] years; 204 [12.2%] aged 65 years or older; 196 [11.8%] American Indian or Alaska Native, 150 [9%] Black or African American, 1112 [66.7%] White; 762 [45.7%] Hispanic or Latino), median (IQR) log 10 VL at diagnosis was 6.18 (4.66-7.12) log 10 copies/mL. Participant characteristics and viral variant explained only 5.9% of the variability in VL. The independent factor with the highest observed differences was trial: Janssen participants had 0.54 log 10 copies/mL lower mean VL vs Moderna participants (95% CI, 0.20 to 0.87 log 10 copies/mL lower). In the Janssen study, which captured the largest number of COVID-19 events and variants and used the most intensive post-COVID surveillance, neither VL at diagnosis nor averaged over days 1 to 28 post diagnosis was associated with COVID-19 severity. Conclusions and Relevance In this study of placebo recipients from 4 randomized phase 3 trials, high variability was observed in SARS-CoV-2 VL at the time of COVID-19 diagnosis, and only a fraction was explained by individual participant characteristics or viral variant. These results suggest challenges for future studies of interventions seeking to influence VL and elevates the importance of standardized methods for specimen collection and viral load quantitation.