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1. Risk of COVID-19 after natural infection or vaccination.

Author

Rick, Anne-Marie, Laurens, Matthew, Huang, Ying, Yu, Chenchen, Martin, Thomas, Rodriguez, Carina, Rostad, Christina, Maboa, Rebone, Baden, Lindsey, El Sahly, Hana, Grinsztejn, Beatriz, Gray, Glenda, Gay, Cynthia, Gilbert, Peter, Janes, Holly, Kublin, James, Huang, Yunda, Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa, Neuzil, Kathleen, Corey, Lawrence, Goepfert, Paul, Walsh, Stephen, Follmann, Dean, and Kotloff, Karen

Subjects
COVID-19, Hybrid immunity, Natural infection, Vaccination
Abstract

BACKGROUND: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. METHODS: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7-15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. FINDINGS: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05-0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01-0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. INTERPRETATION: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. FUNDING: National Institutes of Health.

Published
2023

2. Immunogenicity and safety of beta variant COVID-19 vaccine AZD2816 and AZD1222 (ChAdOx1 nCoV-19) as primary-series vaccination for previously unvaccinated adults in Brazil, South Africa, Poland, and the UK: a randomised, partly double-blinded, phase 2/3 non-inferiority immunobridging study

Author

de Oliveira Paiva, Hugo Diógenes, Smith, Catherin C, Brites, Carlos, Sprinz, Eduardo, Vasconcellos, Eduardo, Badal-Faesen, Sharlaa, Koen, Anthonet, Burgess, Lesley, Engelbrecht, Johannes, Vekemans, Johan, Kobielusz-Gembala, Iwona, Jones, Colin, Hirsch, Ian, Aksyuk, Anastasia, Wilkins, Deidre, Stanely, Ann Marie, Petropoulos, Christos J, Wrin, Terri, Rugieri, Sidelcina, Bennet, Jaclyn A, Greffrath, Johann, Sorio, Guilherme L, Mantyka, Jolanta, Costa Clemens, Sue Ann, Jepson, Brett, Bhorat, Qasim E, Ahmad, Abdullahi, Akhund, Tauseefullah, Aley, Parvinder K, Bansal, Himanshu, Bibi, Sagida, Kelly, Elizabeth J, Khan, Mark, Lambe, Teresa, Lombaard, Johan J, Matthews, Sam, Pipolo Milan, Eveline, Olsson, Urban, Ramasamy, Maheshi N, Moura de Oliveira Paiva, Maria Sanali, Seegobin, Seth, Shoemaker, Kathryn, Szylak, Ameena, Villafana, Tonya, Pollard, Andrew J, and Green, Justin A

Published
2024
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4. Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine

Author

Benkeser, David, Fong, Youyi, Janes, Holly E., Kelly, Elizabeth J., Hirsch, Ian, Sproule, Stephanie, Stanley, Ann Marie, Maaske, Jill, Villafana, Tonya, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Ayala, Victor, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Carpp, Lindsay N., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Isaacs, Margaret Brewinski, Makhene, Mamodikoe, Tong, Tina, Robb, Merlin L., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Hoffman, Corey, Falsey, Ann R., Sobieszczyk, Magdalena, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2023
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6. Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

Author

Falsey, Ann R, Sobieszczyk, Magdalena E, Hirsch, Ian, Sproule, Stephanie, Robb, Merlin L, Corey, Lawrence, Neuzil, Kathleen M, Hahn, William, Hunt, Julie, Mulligan, Mark J, McEvoy, Charlene, DeJesus, Edwin, Hassman, Michael, Little, Susan J, Pahud, Barbara A, Durbin, Anna, Pickrell, Paul, Daar, Eric S, Bush, Larry, Solis, Joel, Carr, Quito Osuna, Oyedele, Temitope, Buchbinder, Susan, Cowden, Jessica, Vargas, Sergio L, Guerreros Benavides, Alfredo, Call, Robert, Keefer, Michael C, Kirkpatrick, Beth D, Pullman, John, Tong, Tina, Brewinski Isaacs, Margaret, Benkeser, David, Janes, Holly E, Nason, Martha C, Green, Justin A, Kelly, Elizabeth J, Maaske, Jill, Mueller, Nancy, Shoemaker, Kathryn, Takas, Therese, Marshall, Richard P, Pangalos, Menelas N, Villafana, Tonya, and Gonzalez-Lopez, Antonio

Subjects
Clinical Trials and Supportive Activities, Lung, Patient Safety, Vaccine Related, Prevention, Immunization, Clinical Research, Infectious Diseases, Emerging Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Neutralizing, Antibodies, Viral, COVID-19, ChAdOx1 nCoV-19, Chile, Double-Blind Method, Female, Humans, Immunogenicity, Vaccine, Male, Middle Aged, Peru, SARS-CoV-2, Spike Glycoprotein, Coronavirus, United States, Vaccine Efficacy, Young Adult, AstraZeneca AZD1222 Clinical Study Group, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.MethodsIn this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.ResultsA total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P

Published
2021

7. Risk of COVID-19 after natural infection or vaccination

Author

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

Published
2023
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9. COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials

Author

Sherman, Amy, primary, Tuan, Jessica, additional, Cantos, Valeria D, additional, Adeyiga, Oladunni, additional, Mahoney, Scott, additional, Ortega-Villa, Ana M, additional, Tillman, Amy, additional, Whitaker, Jennifer, additional, Woodward Davis, Amanda S, additional, Leav, Brett, additional, Hirsch, Ian, additional, Sadoff, Jerald, additional, Dunkle, Lisa M, additional, Gilbert, Peter B, additional, Janes, Holly E, additional, Kublin, James G, additional, Goepfert, Paul A, additional, Kotloff, Karen, additional, Rouphael, Nadine, additional, Falsey, Ann R, additional, El Sahly, Hana M, additional, Sobieszczyk, Magdalena E, additional, Huang, Yunda, additional, Neuzil, Kathleen M, additional, Corey, Lawrence, additional, Grinsztejn, Beatriz, additional, Gray, Glenda, additional, Nason, Martha, additional, Baden, Lindsey R, additional, and Gay, Cynthia L, additional

Published
2024
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12. COVID-19 Vaccine Efficacy in Participants With Weakened Immune Systems From 4 Randomized Controlled Trials.

Author

Sherman, Amy C, Tuan, Jessica, Cantos, Valeria D, Adeyiga, Oladunni, Mahoney, Scott, Ortega-Villa, Ana M, Tillman, Amy, Whitaker, Jennifer, Davis, Amanda S Woodward, Leav, Brett, Hirsch, Ian, Sadoff, Jerald, Dunkle, Lisa M, Gilbert, Peter B, Janes, Holly E, Kublin, James G, Goepfert, Paul A, Kotloff, Karen, Rouphael, Nadine, and Falsey, Ann R

Subjects
NUTRITION disorders, PLACEBOS, VACCINE effectiveness, IMMUNOCOMPROMISED patients, STATISTICAL sampling, IMMUNE system, COVID-19 vaccines, RANDOMIZED controlled trials, PHARMACEUTICAL industry
Abstract

Background Although the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions. Methods A post hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, coronavirus disease 2019 (COVID-19) vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a "tempered immune system" (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS individuals starting at 14 days after completion of the primary series through the blinded phase for each of the 4 trials. An analysis of participants living with well-controlled human immunodeficiency virus was conducted using the same methods. Results A total of 3852/30 351 (12.7%) Moderna participants, 3088/29 868 (10.3%) Novavax participants, 3549/32 380 (11.0%) AstraZeneca participants, and 5047/43 788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (vs placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants versus non-TIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with human immunodeficiency virus. Conclusions For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared with those with non-TIS in the 4 COVID-19 vaccine randomized controlled efficacy trials. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Correlates of protection against symptomatic and asymptomatic SARS-CoV-2 infection

Author

Feng, Shuo, Phillips, Daniel J., White, Thomas, Sayal, Homesh, Aley, Parvinder K., Bibi, Sagida, Dold, Christina, Fuskova, Michelle, Gilbert, Sarah C., Hirsch, Ian, Humphries, Holly E., Jepson, Brett, Kelly, Elizabeth J., Plested, Emma, Shoemaker, Kathryn, Thomas, Kelly M., Vekemans, Johan, Villafana, Tonya L., Lambe, Teresa, Pollard, Andrew J., and Voysey, Merryn

Published
2021
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18. Risk of COVID-19 after natural infection or vaccination

Author

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

Published
2023
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19. Durability of protection and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine over 6 months

Author

Sobieszczyk, Magdalena E., Maaske, Jill, Falsey, Ann R., Sproule, Stephanie, Robb, Merlin L., Frenck, Robert W., Jr., Tieu, Hong-Van, Mayer, Kenneth H., Corey, Lawrence, Neuzil, Kathleen M., Tong, Tina, Isaacs, Margaret Brewinski, Janes, Holly, Bansal, Himanshu, Edwards, Lindsay M., Green, Justin A., Kelly, Elizabeth J., Shoemaker, Kathryn, Takas, Therese, White, Tom, Bhuyan, Prakash, Villafana, Tonya, and Hirsch, Ian

Subjects
Communicable diseases in children -- Prevention, Pediatric research, Health care industry, AZD1222 (Vaccine) -- Testing
Abstract

BACKGROUND. We report updated safety, efficacy, and immunogenicity of AZD1222 (ChAdOx1 nCoV-19) from an ongoing phase 3 trial. METHODS. Adults at increased risk of SARS-CoV-2 infection were randomized (2:1), stratified by age, to receive 2 doses of AZD1222 or placebo. The primary efficacy end point was confirmed SARS-CoV-2 reverse-transcriptase PCR-positive (RT-PCRpositive) symptomatic COVID-19 at 15 or more days after a second dose in baseline SARS-CoV-2-seronegative participants. The 21,634 and 10,816 participants were randomized to AZD1222 and placebo, respectively. FINDINGS. Data cutoff for this analysis was July 30, 2021; median follow-up from second dose was 78 and 71 days for the doubleblind period (censoring at unblinding or nonstudy COVID-19 vaccination) and 201 and 82 days for the period to nonstudy COVID-19 vaccination (regardless of unblinding) in the AZD1222 and placebo groups, respectively. For the primary efficacy end point in the double-blind period (141 and 184 events; incidence rates: 39.2 and 118.8 per 1,000 person years), vaccine efficacy was 67.0% (P < 0.001). In the period to nonstudy COVID-19 vaccination, incidence of events remained consistently low and stable through 6 months in the AZD1222 group; for the primary efficacy end point (328 and 219 events; incidence rates: 36.4, 108.4) and severe/ critical disease (5 and 13 events; incidence rates: 0.6, 6.4), respective vaccine efficacy estimates were 65.1% and 92.1%. AZD1222 elicited humoral immune responses over time, with waning at day 180. No emergent safety issues were seen. CONCLUSION. AZD1222 is safe and well tolerated, demonstrating durable protection and immunogenicity with median followup (AZD1222 group) of 6 months. TRIAL REGISTRATION. ClinicalTrials.gov NCT04516746. FUNDING. AstraZeneca; US government., Introduction There is an ongoing critical need for vaccination in the fight against the global COVID-19 pandemic. Understanding the durability of vaccine efficacy (VE) and immunogenicity is important in the [...]

Published
2022
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21. Immune Checkpoint Inhibitors in Advanced Cutaneous Squamous Cell Carcinoma: Real-World Experience from a Canadian Comprehensive Cancer Centre

Author

Koch Hein, Erica C., primary, Vilbert, Maysa, additional, Hirsch, Ian, additional, Fernando Ribeiro, Mauricio, additional, Muniz, Thiago P., additional, Fournier, Cynthia, additional, Abdulalem, Khaled, additional, Saldanha, Erick F., additional, Martinez, Erika, additional, Spreafico, Anna, additional, Hogg, David H., additional, Butler, Marcus O., additional, and Saibil, Samuel D., additional

Published
2023
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22. Immune Checkpoint Inhibitors in Advanced Cutaneous Squamous Cell Carcinoma: Real-World Experience from a Canadian Comprehensive Cancer Centre

Author

Koch Hein, Erica Cristina, primary, Vilbert, Maysa, additional, Hirsch, Ian, additional, Ribeiro, Mauricio Fernando, additional, Muniz, Thiago Pimentel, additional, Fournier, Cynthia, additional, Abdulalem, Khaled, additional, Figueiredo Saldanha, Erick, additional, Martinez, Erika, additional, Spreafico, Anna, additional, Hogg, David Hartwick, additional, Butler, Marcus Otho, additional, and Saibil, Samuel David, additional

Published
2023
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24. Clinico-demographic characteristics and outcomes of radiation-induced sarcomas (RIS): a CanSaRCC study

Author

Ribeiro, Mauricio Fernando, primary, Peretz Soroka, Hagit, additional, Bhura, Zainab, additional, Hirsch, Ian, additional, Wunder, Jay, additional, Ferguson, Peter, additional, Tsoi, Kim, additional, Brar, Savtaj, additional, Gladdy, Rebecca, additional, Swallow, Carol, additional, Chung, Peter, additional, Catton, Charles, additional, Wong, Philip, additional, Watson, Geoffrey, additional, Razak, Albiruni Ryan Abdul, additional, Gupta, Abha A., additional, and Shultz, David, additional

Published
2023
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27. Cáncer de ovario de células transicionales

Author

Pinto, María Paula, primary, Alcántara, Janeth Lara, additional, Costa, Johanna, additional, Hirsch, Ian, additional, Piñón, Lucía, additional, Comesaña, Gabriela, additional, Samec, Miguel, additional, Servienti, Patricio, additional, Ortellado, María L., additional, and Aranda, Laura E., additional

Published
2022
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29. Single Dose Administration, And The Influence Of The Timing Of The Booster Dose On Immunogenicity and Efficacy Of ChAdOx1 nCoV-19 (AZD1222) Vaccine

Author

Voysey, Merryn, Costa Clemens, Sue Ann, Madhi, Shabir A, Weckx, Lily Yin, Folegatti, Pedro M, Aley, Parvinder K, Angus, Brian John, Baillie, Vicky, Barnabas, Shaun L, Bhorat, Qasim E, Bibi, Sagida, Briner, Carmen, Cicconi, Paola, Clutterbuck, Elizabeth, Collins, Andrea M, Cutland, Clare, Darton, Thomas, Dheda, Keertan, Douglas, Alexander D, Duncan, Christopher JA, Emary, Katherine RW, Ewer, Katie, Flaxman, Amy, Fairlie, Lee, Faust, Saul N, Feng, Shuo, Ferreira, Daniela M, Finn, Adam, Galiza, Eva, Goodman, Anna L, Green, Catherine M, Green, Christopher A, Greenland, Melanie, Hill, Catherine, Hill, Helen C, Hirsch, Ian, Izu, Alane, Jenkin, Daniel, Kerridge, Simon, Koen, Anthonet, Kwatra, Gaurav, Lazarus, Rajeka, Libri, Vincenzo, Lillie, Patrick J, Marchevsky, Natalie, Marshall, Richard P, Mendes, Ana Verena Almeida, Milan, Eveline P, Minassian, Angela M, McGregor, Alastair C, Farooq Mujadidi, Yama, Nana, Anusha, Payadachee, Sherman D, Phillips, Daniel J, Pittella, Ana, Plested, Emma, Pollock, Katrina M, Ramasamy, Maheshi N, Robinson, Hannah, Schwarzbold, Alexandre V, Smith, Andrew, Song, Rinn, Snape, Matthew D, Sprinz, Eduardo, Sutherland, Rebecca K, Thomson, Emma C, Török, Mili Estée, Toshner, Mark, Turner, David PJ, Vekemans, Johan, Villafana, Tonya L, White, Thomas, Williams, Christopher J, Hill, Adrian VS, Lambe, Teresa, Gilbert, Sarah C, Pollard, Andrew, and Group, Oxford COVID Vaccine Trial

Published
2022
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31. A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated

Author

Follmann, Dean, primary, Fintzi, Jonathan, additional, Fay, Michael P., additional, Janes, Holly E., additional, Baden, Lindsey R., additional, El Sahly, Hana M., additional, Fleming, Thomas R., additional, Mehrotra, Devan V., additional, Carpp, Lindsay N., additional, Juraska, Michal, additional, Benkeser, David, additional, Donnell, Deborah, additional, Fong, Youyi, additional, Han, Shu, additional, Hirsch, Ian, additional, Huang, Ying, additional, Huang, Yunda, additional, Hyrien, Ollivier, additional, Luedtke, Alex, additional, Carone, Marco, additional, Nason, Martha, additional, Vandebosch, An, additional, Zhou, Honghong, additional, Cho, Iksung, additional, Gabriel, Erin, additional, Kublin, James G., additional, Cohen, Myron S., additional, Corey, Lawrence, additional, Gilbert, Peter B., additional, and Neuzil, Kathleen M., additional

Published
2021
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32. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials

Author

Voysey, Merryn, Costa Clemens, Sue Ann, Madhi, Shabir A, Weckx, Lily Y, Folegatti, Pedro M, Aley, Parvinder K, Angus, Brian, Baillie, Vicky L, Barnabas, Shaun L, Bhorat, Qasim E, Bibi, Sagida, Briner, Carmen, Cicconi, Paola, Clutterbuck, Elizabeth A, Collins, Andrea M, Cutland, Clare L, Darton, Thomas C, Dheda, Keertan, Dold, Christina, Duncan, Christopher JA, Emary, Katherine RW, Ewer, Katie J, Flaxman, Amy, Fairlie, Lee, Faust, Saul N, Feng, Shuo, Ferreira, Daniela M, Finn, Adam, Galiza, Eva, Goodman, Anna L, Green, Catherine M, Green, Christopher A, Greenland, Melanie, Hill, Catherine, Hill, Helen C, Hirsch, Ian, Izu, Alane, Jenkin, Daniel, Joe, Carina CD, Kerridge, Simon, Koen, Anthonet, Kwatra, Gaurav, Lazarus, Rajeka, Libri, Vincenzo, Lillie, Patrick J, Marchevsky, Natalie G, Marshall, Richard P, Mendes, Ana VA, Milan, Eveline P, Minassian, Angela M, McGregor, Alastair, Mujadidi, Yama F, Nana, Anusha, Padayachee, Sherman D, Phillips, Daniel J, Pittella, Ana, Plested, Emma, Pollock, Katrina M, Ramasamy, Maheshi N, Ritchie, Adam J, Robinson, Hannah, Schwarzbold, Alexandre V, Smith, Andrew, Song, Rinn, Snape, Matthew D, Sprinz, Eduardo, Sutherland, Rebecca K, Thomson, Emma C, Török, M Estée, Toshner, Mark, Turner, David PJ, Vekemans, Johan, Villafana, Tonya L, White, Thomas, Williams, Christopher J, Douglas, Alexander D, Hill, Adrian VS, Lambe, Teresa, Gilbert, Sarah C, Pollard, Andrew J, and Oxford COVID Vaccine Trial Group

Abstract

Background\ud The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4-12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered.MethodsWe present data from three single-blind randomised controlled trials-one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)-and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 1010 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 1010 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005).FindingsBetween April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more than 14 days after the second dose. Overall vaccine efficacy more than 14 days after the second dose was 66·7% (95% CI 57·4-74·0), with 84 (1·0%) cases in the 8597 participants in the ChAdOx1 nCoV-19 group and 248 (2·9%) in the 8581 participants in the control group. There were no hospital admissions for COVID-19 in the ChAdOx1 nCoV-19 group after the initial 21-day exclusion period, and 15 in the control group. 108 (0·9%) of 12 282 participants in the ChAdOx1 nCoV-19 group and 127 (1·1%) of 11 962 participants in the control group had serious adverse events. There were seven deaths considered unrelated to vaccination (two in the ChAdOx1 nCov-19 group and five in the control group), including one COVID-19-related death in one participant in the control group. Exploratory analyses showed that vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 after vaccination was 76·0% (59·3-85·9). Our modelling analysis indicated that protection did not wane during this initial 3-month period. Similarly, antibody levels were maintained during this period with minimal waning by day 90 (geometric mean ratio [GMR] 0·66 [95% CI 0·59-0·74]). In the participants who received two standard doses, after the second dose, efficacy was higher in those with a longer prime-boost interval (vaccine efficacy 81·3% [95% CI 60·3-91·2] at ≥12 weeks) than in those with a short interval (vaccine efficacy 55·1% [33·0-69·9] at InterpretationThe results of this primary analysis of two doses of ChAdOx1 nCoV-19 were consistent with those seen in the interim analysis of the trials and confirm that the vaccine is efficacious, with results varying by dose interval in exploratory analyses. A 3-month dose interval might have advantages over a programme with a short dose interval for roll-out of a pandemic vaccine to protect the largest number of individuals in the population as early as possible when supplies are scarce, while also improving protection after receiving a second dose.FundingUK Research and Innovation, National Institutes of Health Research (NIHR), The Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.

Published
2021

33. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Author

Voysey, Merryn, Clemens, Sue Ann Costa, Madhi, Shabir A., Weckx, Lily Y., Folegatti, Pedro M., Aley, Parvinder K., Angus, Brian, Baillie, Vicky L., Barnabas, Shaun L., Bhorat, Qasim E., Bibi, Sagida, Briner, Carmen, Cicconi, Paola, Collins, Andrea M., Colin-Jones, Rachel, Cutland, Clare L., Darton, Thomas C., Dheda, Keertan, Duncan, Christopher J. A., Emary, Katherine R. W., Ewer, Katie J., Fairlie, Lee, Faust, Saul N., Feng, Shuo, Ferreira, Daniela M., Finn, Adam, Goodman, Anna L., Green, Catherine M., Green, Christopher A., Heath, Paul T., Hill, Catherine, Hill, Helen, Hirsch, Ian, Hodgson, Susanne H. C., Izu, Alane, Jackson, Susan, Jenkin, Daniel, Joe, Carina C. D., Kerridge, Simon, Koen, Anthonet, Kwatra, Gaurav, Lazarus, Rajeka, Lawrie, Alison M., Lelliott, Alice, Libri, Vincenzo, Lillie, Patrick J., Mallory, Raburn, Mendes, Ana V. A., Milan, Eveline P., Minassian, Angela M., McGregor, Alastair, Morrison, Hazel, Mujadidi, Yama F., Nana, Anusha, O'Reilly, Peter J., Padayachee, Sherman D., Pittella, Ana, Plested, Emma, Pollock, Katrina M., Ramasamy, Maheshi N., Rhead, Sarah, Schwarzbold, Alexandre V., Singh, Nisha, Smith, Andrew, Song, Rinn, Snape, Matthew D., Sprinz, Eduardo, Sutherland, Rebecca K., Tarrant, Richard, Thomson, Emma C., Török, Mark and Turner, Sorio, Guilherme L., Sorley, Kim, Sosa-Rodriguez, Tiffany, Souza, Cinthia M.C.D.L., Souza, Bruno S.D.F., Souza, Alessandra R., Spencer, Alexandra J., Spina, Fernanda, Spoors, Louise, Stafford, Lizzie, Stamford, Imogen, Starinskij, Igor, Stein, Ricardo, Steven, Jill, Stockdale, Lisa, Stockwell, Lisa V., Strickland, Louise H., Stuart, Arabella C., Sturdy, Ann, Sutton, Natalina, Szigeti, Anna, Tahiri-Alaoui, Abdessamad, Tanner, Rachel, Taoushanis, Carol, Tarr, Alexander W., Taylor, Keja, Taylor, Ursula, Taylor, Iona Jennifer, Taylor, Justin, te Water Naude, Rebecca, Themistocleous, Yrene, Themistocleous, Andreas, Thomas, Merin, Thomas, Kelly, Thomas, Tonia M., Thombrayil, Asha, Thompson, Fawziyah, Thompson, Amber, Thompson, Kevin, Thompson, Ameeka, Thomson, Julia, Thornton-Jones, Viv, Tighe, Patrick J., Tinoco, Lygia Accioly, Tiongson, Gerlynn, Tladinyane, Bonolo, Tomasicchio, Michele, Tomic, Adriana, Tonks, Susan, Tran, Nguyen, Tree, Julia, Trillana, Gerry, Trinham, Charlotte, Trivett, Rose, Truby, Adam, Tsheko, Betty Lebogang, Turabi, Aadil, Turner, Richard, Turner, Cheryl, Ulaszewska, Marta, Underwood, Benjamin R., Varughese, Rachel, Verbart, Dennis, Verheul, Marije, Vichos, Iason, Vieira, Taiane, Waddington, Claire S., Walker, Laura, Wallis, Erica, Wand, Matthew, Warbick, Deborah, Wardell, Theresa, Warimwe, George, Warren, Sarah C., Watkins, Bridget, Watson, Ekaterina, Webb, Stewart, Webb-Bridges, Alice, Webster, Angela, Welch, Jessica, Wells, Jeanette, West, Alison, White, Caroline, White, Rachel, Williams, Paul, Williams, Rachel L., Winslow, Rebecca, Woodyer, Mark, Worth, Andrew T., Wright, Danny, Wroblewska, Marzena, Yao, Andy, Zimmer, Rafael, Zizi, Dalila, and Zuidewind, Peter

Abstract

Background: \ud A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials.\ud \ud Methods: \ud This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674.\ud \ud Findings: \ud Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation.\ud \ud Interpretation: \ud ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.\ud \ud Funding: \ud UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.

Published
2021

35. Benefit–risk assessment in a post-market setting: a case study integrating real-life experience into benefit–risk methodology†

Author

Hallgreen, Christine E., van den Ham, Hendrika A., Mt-Isa, Shahrul, Ashworth, Simon, Hermann, Richard, Hobbiger, Steve, Luciani, Davide, Micaleff, Alain, Thomson, Andrew, Wang, Nan, van Staa, Tjeerd P., Downey, Gerald, Hirsch, Ian, Hockley, Kimberley, Juhaeri, Juhaeri, Metcalf, Marilyn, Mwangi, Jeremiah, Nixon, Richard, Peters, Ruth, Stoeckert, Isabelle, Waddingham, Ed, Tzoulaki, Ioanna, Ashby, Deborah, and Wise, Lesley

Published
2014
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37. Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

Author

Mehrotra, Devan V., primary, Janes, Holly E., additional, Fleming, Thomas R., additional, Annunziato, Paula W., additional, Neuzil, Kathleen M., additional, Carpp, Lindsay N., additional, Benkeser, David, additional, Brown, Elizabeth R., additional, Carone, Marco, additional, Cho, Iksung, additional, Donnell, Deborah, additional, Fay, Michael P., additional, Fong, Youyi, additional, Han, Shu, additional, Hirsch, Ian, additional, Huang, Ying, additional, Huang, Yunda, additional, Hyrien, Ollivier, additional, Juraska, Michal, additional, Luedtke, Alex, additional, Nason, Martha, additional, Vandebosch, An, additional, Zhou, Honghong, additional, Cohen, Myron S., additional, Corey, Lawrence, additional, Hartzel, Jonathan, additional, Follmann, Dean, additional, and Gilbert, Peter B., additional

Published
2021
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38. Single Dose&nbsp;Administration,&nbsp;And&nbsp;The&nbsp;Influence Of&nbsp;The&nbsp;Timing Of&nbsp;The&nbsp;Booster Dose&nbsp;On Immunogenicity and Efficacy Of&nbsp;ChAdOx1 nCoV-19&nbsp;(AZD1222)&nbsp;Vaccine

Author

Voysey, Merryn, primary, Costa Clemens, Sue Ann, additional, Madhi, Shabir A., additional, Weckx, Lily Yin, additional, Folegatti, Pedro M., additional, Aley, Parvinder K., additional, Angus, Brian John, additional, Baillie, Vicky, additional, Barnabas, Shaun L., additional, Bhorat, Qasim E., additional, Bibi, Sagida, additional, Briner, Carmen, additional, Cicconi, Paola, additional, Clutterbuck, Elizabeth, additional, Collins, Andrea M., additional, Cutland, Clare, additional, Darton, Thomas, additional, Dheda, Keertan, additional, Douglas, Alexander D., additional, Duncan, Christopher J. A., additional, Emary, Katherine R. W., additional, Ewer, Katie, additional, Flaxman, Amy, additional, Fairlie, Lee, additional, Faust, Saul N., additional, Feng, Shuo, additional, Ferreira, Daniela M., additional, Finn, Adam, additional, Galiza, Eva, additional, Goodman, Anna L., additional, Green, Catherine M., additional, Green, Christopher A., additional, Greenland, Melanie, additional, Hill, Catherine, additional, Hill, Helen C., additional, Hirsch, Ian, additional, Izu, Alane, additional, Jenkin, Daniel, additional, Kerridge, Simon, additional, Koen, Anthonet, additional, Kwatra, Gaurav, additional, Lazarus, Rajeka, additional, Libri, Vincenzo, additional, Lillie, Patrick J., additional, Marchevsky, Natalie G., additional, Marshall, Richard P., additional, Mendes, Ana Verena Almeida, additional, Milan, Eveline P., additional, Minassian, Angela M., additional, McGregor, Alastair C., additional, Farooq Mujadidi, Yama, additional, Nana, Anusha, additional, Payadachee, Sherman D., additional, Phillips, Daniel J., additional, Pittella, Ana, additional, Plested, Emma, additional, Pollock, Katrina M., additional, Ramasamy, Maheshi N., additional, Robinson, Hannah, additional, Schwarzbold, Alexandre V., additional, Smith, Andrew, additional, Song, Rinn, additional, Snape, Matthew D., additional, Sprinz, Eduardo, additional, Sutherland, Rebecca K., additional, Thomson, Emma C., additional, Torok, Mili, additional, Toshner, Mark, additional, Turner, David P. J., additional, Vekemans, Johan, additional, Villafana, Tonya L., additional, White, Thomas, additional, Williams, Christopher J., additional, Hill, Adrian V. S., additional, Lambe, Teresa, additional, Gilbert, Sarah C., additional, Pollard, Andrew, additional, and Group, Oxford COVID Vaccine Trial, additional

Published
2021
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39. Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials

Author

Follmann, Dean, primary, Fintzi, Jonathan, additional, Fay, Michael P., additional, Janes, Holly E., additional, Baden, Lindsey, additional, Sahly, Hana El, additional, Fleming, Thomas R., additional, Mehrotra, Devan V., additional, Carpp, Lindsay N., additional, Juraska, Michal, additional, Benkeser, David, additional, Donnell, Deborah, additional, Fong, Youyi, additional, Han, Shu, additional, Hirsch, Ian, additional, Huang, Ying, additional, Huang, Yunda, additional, Hyrien, Ollivier, additional, Luedtke, Alex, additional, Carone, Marco, additional, Nason, Martha, additional, Vandebosch, An, additional, Zhou, Honghong, additional, Cho, Iksung, additional, Gabriel, Erin, additional, Kublin, James G., additional, Cohen, Myron S., additional, Corey, Lawrence, additional, Gilbert, Peter B., additional, and Neuzil, Kathleen M., additional

Published
2020
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48. Benralizumab treatment and SARP cluster analysis

Author

Bleecker, Eugene R., primary, Li, Xingnan, additional, Newbold, Paul, additional, Hirsch, Ian, additional, Li, Huashi, additional, Zangrilli, James, additional, Goldman, Mitchell, additional, and Meyers, Deborah A., additional

Published
2019
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