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1. Risk of COVID-19 after natural infection or vaccinationResearch in context

Author

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

Subjects
COVID-19, Natural infection, Hybrid immunity, Vaccination, Medicine, Medicine (General), R5-920
Abstract

Summary: 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
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2. Development of a learning health system science competency assessment to guide training and proficiency assessment

Author

Patricia D. Franklin, Denise Drane, Lauren Wakschlag, Ronald Ackerman, Abel Kho, and David Cella

Subjects
assessment, competency, curriculum, learning health systems, Medicine (General), R5-920, Public aspects of medicine, RA1-1270
Abstract

Abstract Introduction Learning health systems (LHS) science is fundamentally a transdisciplinary field. To capture the breadth of the competencies of an LHS scientist, AHRQ and national experts defined a series of 42 competencies across seven domains that support success. Clinicians, researchers, and leaders who are new to the LHS field can identify and prioritize proficiency development among these domains. In addition, existing leaders and researchers will assemble teams of experts who together represent the LHS science domains. To serve LHS workforce development and proficiency assessment, the AHRQ‐funded ACCELERAT K12 training program recruited domain experts and trainees to define and operationalize items to include in an LHS Competency Assessment to support emerging and existing LHS scientists in prioritizing and monitoring proficiency development. Methods Sequential interviews with 18 experts iteratively defined skills and tasks to illustrate stage in proficiency, and its progression, for each of 42 competencies in the seven LHS expertise domains: systems science; research questions and standards of scientific evidence; research methods; informatics; ethics of research and implementation in health systems; improvement and implementation science; and engagement, leadership, and research management. An educational assessment expert and LHS scientist refined the assessment criteria at each stage to use parallel language across domains. Last, current trainees reviewed and pilot tested the assessment and the LHS Competency Assessment was further refined using their feedback. The assessment framework was informed by Bloom's revised taxonomy of educational objectives (Anderson and Krathwohl, A taxonomy for learning, teaching, and assessing: A revision of Bloom's taxonomy of educational objectives, 2001) where learning progresses from recalling, defining, understanding, and awareness at the lower levels of the taxonomy, to applying and adopting and finally to creating, designing, and critiquing at the upper levels of the taxonomy. We also developed assessment criteria that could be used for longer term assessment of direct performance. Van der Vleuten et al. (Best Pract Res Clin Obstetr Gynaecol. 2010;24(6):703‐719) define longer term direct assessment methods as assessment that occurs over a period ranging from weeks to even years and involves multiple assessment methods and exposure to the learner's work over an extended period. Results This experience report describes the content of the LHS Competency Assessment. For each domain and competency, the assessment lists examples of evidence to support expertise at each level of proficiency: no exposure; foundational (awareness/understanding); emerging (early application); and proficient (application with a high level of skill). Trainees begin with baseline standard assessment tables, where they can indicate no exposure or mark the foundational and emerging skills with which they have competence. For domains where foundational and emerging skills have been achieved, users can move on to assessment tables that list evidence of proficiency. Conclusion The LHS Competency Assessment offers consistent, graded criteria across the seven LHS domains to guide trainees and mentors to evaluate progress from no experience to foundational knowledge, emerging proficiency, and proficiency. The assessment can also be used to design training and mentoring for those newly exposed to LHS science and for those with key expertise who wish to expand LHS expertise.

Published
2022
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3. Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis

Author

Rebecca A. Lillis, R. Lamar Parker, Ronald Ackerman, Jamie Ackerman, Stephen Young, Alice Weissfeld, Ernest Trevino, Irving Nachamkin, LaShonda Crane, Jacqueline Brown, Christina Huang, Xiaohong Liu, and Barbara Van Der Pol

Subjects
Microbiology (medical)
Abstract

In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States.

Published
2023
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4. Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test

Author

Jeffrey C Andrews, Amanda Montano, Charles K. Cooper, Katey G. Varnado, Cameron Burgard, Celine Roger-Dalbert, Stephen G. Young, Joseph G. Allen, Christen Griego-Fullbright, Karen Eckert, Stephanie N. Taylor, Catherine L. Cammarata, Huimiao Ren, Ronald Ackerman, Catherine Fernandez, and Miller, Melissa B

Subjects
0301 basic medicine, Male, Emergency Use Authorization, Oropharynx, Polymerase Chain Reaction, Medical and Health Sciences, 0302 clinical medicine, COVID-19 Testing, Veritor test, Nasopharynx, 030212 general & internal medicine, Viral, Lung, Immunoassay, medicine.diagnostic_test, respiratory system, Middle Aged, Biological Sciences, Spike Glycoprotein, Infectious Diseases, Nasal Swab, Point-of-Care Testing, Female, point-of-care test, Clinical evaluation, Adult, Microbiology (medical), medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Point-of-care testing, 030106 microbiology, Sensitivity and Specificity, Microbiology, Vaccine Related, 03 medical and health sciences, Antigen, Clinical Research, Internal medicine, Biodefense, medicine, Humans, Coronavirus Nucleocapsid Proteins, Antigens, Agricultural and Veterinary Sciences, business.industry, SARS-CoV-2, Prevention, COVID-19, Sofia 2 test, Coronavirus, Emerging Infectious Diseases, Good Health and Well Being, business
Abstract

The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO, ≥18 years of age) were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). The positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. In study 1, the PPA for Veritor, compared to Lyra, ranged from 81.8 to 87.5% across the 0 to 1 and 0 to 6 DSO ranges. In study 2, Veritor had PPA, NPA, and OPA values of 97.4, 98.1, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 antigen testing for the 0 to 5 and 0 to 6 DSO ranges (PPA values of 83.9% and 82.4%, respectively). Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs but demonstrated

Published
2020
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5. Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test

Author

Stephen, Young, Stephanie N, Taylor, Catherine L, Cammarata, Katey G, Varnado, Celine, Roger-Dalbert, Amanda, Montano, Christen, Griego-Fullbright, Cameron, Burgard, Catherine, Fernandez, Karen, Eckert, Jeffrey C, Andrews, Huimiao, Ren, Joseph, Allen, Ronald, Ackerman, and Charles K, Cooper

Subjects
Adult, Immunoassay, Male, Simplexa RT-PCR, SARS-CoV-2, the Veritor test, COVID-19, Oropharynx, Middle Aged, Polymerase Chain Reaction, Sensitivity and Specificity, antigen test, COVID-19 Testing, Point-of-Care Testing, Nasopharynx, Spike Glycoprotein, Coronavirus, Coronavirus Nucleocapsid Proteins, Humans, Female, Antigens, Viral, Letter to the Editor
Abstract

The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO, ≥18 years of age) were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). The positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. In study 1, the PPA for Veritor, compared to Lyra, ranged from 81.8 to 87.5% across the 0 to 1 and 0 to 6 DSO ranges. In study 2, Veritor had PPA, NPA, and OPA values of 97.4, 98.1, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 antigen testing for the 0 to 5 and 0 to 6 DSO ranges (PPA values of 83.9% and 82.4%, respectively). Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs but demonstrated100% PPA compared to PCR.

Published
2020

6. Clinical evaluation of BD Veritor™SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia®2 SARS Antigen point-of-care test

Author

Devin S. Gary, Stephen G. Young, Joseph G. Allen, Cameron Burgard, Jeffrey C Andrews, Karen Eckert, Stephanie N. Taylor, Celine Roger-Dalbert, Christen Griego-Fullbright, Amanda Montano, Charles K. Cooper, Huimiao Ren, Catherine L. Cammarata, Ronald Ackerman, and Catherine Fernandez

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Point-of-care testing, Clinical performance, Rapid detection, Antigen, Nasal Swab, Internal medicine, Immunoassay, Medicine, business, Clinical evaluation
Abstract

ObjectivesThe clinical performance of the BD Veritor™ System for Rapid Detection of SARS-CoV-2 antigen (Veritor), a chromatographic immunoassay that detects the SARS-CoV-2 nucleocapsid antigen as a point-of-care test, was evaluated on nasal specimens from individuals with COVID-19 symptoms.Methods and MaterialsTwo studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO]), ≥18 years of age, were utilized to compare Veritor with the Lyra®SARS-CoV-2 PCR Assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO), ≥18 years of age, were utilized to compare performance of Veritor to that of the Sofia®2 SARS Antigen FIA test (Sofia 2). Positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes.ResultsIn study 1, PPA for Veritor, compared to Lyra, ranged from 81.8%-87.5% for 0-1 through 0-6 DSO ranges. In study 2, Veritor had a PPA, NPA, and OPA of 97.4%, 98.1%, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra.ConclusionsVeritor met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing (≥80% PPA point estimate) for the 0-5 and 0-6 DSO ranges. Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test should facilitate rapid and reliable results for COVID-19 diagnosis utilizing easy-to-collect nasal swabs.SummaryThe BD Veritor SARS-CoV-2 antigen test met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing for subjects with COVID-19 symptoms (0-5 days post-onset). BD Veritor and Quidel Sofia 2 antigen tests had good agreement for SARS-CoV-2 detection; discordant analysis favored Veritor.

Published
2020
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7. Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study

Author

Neil B. Quigley, Jane R. Schwebke, Paul Nyirjesy, Craig Clark, Damon K. Getman, Steven E. Chavoustie, Charlotte A. Gaydos, Byron McKinney, Stephanie N. Taylor, Carmelle V. Remillard, Ronald Ackerman, Robert Schlaberg, Philip Estes, and Onderdonk, Andrew B

Subjects
0301 basic medicine, Aptima, specificity, medicine.disease_cause, Medical and Health Sciences, 0302 clinical medicine, Trichomonas Vaginitis, Medicine, 030212 general & internal medicine, Prospective Studies, Candida, screening and diagnosis, Trichomoniasis, biology, Bacterial, Candidiasis, Vaginosis, Bacterial, Middle Aged, Biological Sciences, Amsel criteria, 3. Good health, Detection, Infectious Diseases, Vagina, Reagent Kits, Female, diagnostic accuracy, Bacterial vaginosis, Infection, Nucleic Acid Amplification Techniques, Vulvovaginal, bacterial vaginosis, Biotechnology, 4.2 Evaluation of markers and technologies, Microbiology (medical), Adult, medicine.medical_specialty, Adolescent, 030106 microbiology, clinician’s diagnosis, Sensitivity and Specificity, Microbiology, 03 medical and health sciences, Young Adult, Clinical Research, Internal medicine, Vaginosis, Trichomonas vaginalis, Genetics, Humans, Diagnostic, Candidiasis, Vulvovaginal, Vaginitis, Aged, Candida glabrata, Bacteria, clinician's diagnosis, Agricultural and Veterinary Sciences, business.industry, United States Food and Drug Administration, Human Genome, Bacteriology, Gold standard (test), biology.organism_classification, medicine.disease, molecular test, sensitivity, candidiasis, United States, 4.1 Discovery and preclinical testing of markers and technologies, Nugent score, Cross-Sectional Studies, Good Health and Well Being, trichomoniasis, Reagent Kits, Diagnostic, business
Abstract

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis., Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis. The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis. Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis. Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians’ diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians’ diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

Published
2020

8. Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas vaginalis with Prospectively Collected Specimens from Men and Women

Author

Hilary Reno, Susan S. Philip, D. Furgerson, Stephanie N. Taylor, Thomas E. Davis, J Lebed, Daron G. Ferris, B Smith, Jeanne M. Marrazzo, Peter R. Kerndt, Laura H. Bachmann, David Eisenberg, Ronald Ackerman, Jeanne A. Jordan, Timothy Spurrell, C. A. Burnham, Neil B. Quigley, Jane R. Schwebke, Charlotte A. Gaydos, and Loeffelholz, Michael J

Subjects
0301 basic medicine, Sexually transmitted disease, Male, trichomonas, diagnosis, Trichomonas, Urine, medicine.disease_cause, Medical and Health Sciences, 0302 clinical medicine, Prevalence, Medicine, NAAT, 030212 general & internal medicine, Prospective Studies, screening and diagnosis, Trichomoniasis, biology, Obstetrics, Biological Sciences, Middle Aged, Detection, Infectious Diseases, female, Vaginal swabs, Vagina, Infection, Clinical evaluation, Nucleic Acid Amplification Techniques, 4.2 Evaluation of markers and technologies, Urologic Diseases, Microbiology (medical), Adult, medicine.medical_specialty, Adolescent, 030106 microbiology, Trichomonas Infections, Microbiology, Sensitivity and Specificity, Specimen Handling, 03 medical and health sciences, Young Adult, Clinical Research, Trichomonas vaginalis, Nucleic Acid Amplification Tests, Humans, Aged, Agricultural and Veterinary Sciences, business.industry, biology.organism_classification, medicine.disease, United States, Good Health and Well Being, Sexually Transmitted Infections, Parasitology, business
Abstract

Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and the acquisition and transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA cleared in the United States for detection of Trichomonas vaginalis in specimens from both women and men. This study reports the results of a multicenter study recently conducted using the Xpert TV ( T. vaginalis ) assay to test specimens from both men and women. On-demand results were available in as little as 40 min for positive specimens. A total of 1,867 women and 4,791 men were eligible for inclusion in the analysis. In women, the performance of the Xpert TV assay was compared to the patient infected status (PIS) derived from the results of InPouch TV broth culture and Aptima NAAT for T. vaginalis . The diagnostic sensitivities and specificities of the Xpert TV assay for the combined female specimens (urine samples, self-collected vaginal swabs, and endocervical swabs) ranged from 99.5 to 100% and 99.4 to 99.9%, respectively. For male urine samples, the diagnostic sensitivity and specificity were 97.2% and 99.9%, respectively, compared to PIS results derived from the results of broth culture for T. vaginalis and bidirectional gene sequencing of amplicons. Excellent performance characteristics were seen using both female and male specimens. The ease of using the Xpert TV assay should result in opportunities for enhanced screening for T. vaginalis in both men and women and, hopefully, improved control of this infection.

Published
2018

9. Efficacy of Flibanserin in Women with Hypoactive Sexual Desire Disorder: Results from the BEGONIA Trial

Author

Parke Hedges, Leonard R. Derogatis, Michael Sand, Lynna M. Lesko, Ronald Ackerman, Molly Katz, and Miguel Garcia

Subjects
Adult, medicine.medical_specialty, Libido, Sexual Behavior, Urology, Endocrinology, Diabetes and Metabolism, Personal Satisfaction, Placebo, Dizziness, Bedtime, Placebos, Endocrinology, Double-Blind Method, Internal medicine, Outcome Assessment, Health Care, medicine, Humans, Bremelanotide, Sexual Dysfunctions, Psychological, Aged, Gynecology, Motivation, Nausea, Hypoactive sexual desire disorder, Middle Aged, Serotonin 5-HT1 Receptor Agonists, medicine.disease, Psychiatry and Mental health, Sexual desire, Sexual dysfunction, Premenopause, Reproductive Medicine, Serotonin 5-HT2 Receptor Antagonists, Flibanserin, Benzimidazoles, Female, medicine.symptom, Psychology, Somnolence, medicine.drug
Abstract

Introduction Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty. Aim The aim of this study was to assess the efficacy and safety of the 5‐HT 1A agonist/5‐HT 2A antagonist flibanserin in premenopausal women with HSDD. Methods This was a randomized, placebo‐controlled trial in which premenopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime (qhs) (n = 542) or placebo (n = 545) for 24 weeks. Main Outcome Measures Coprimary end points were the change from baseline to study end in Female Sexual Function Index (FSFI) desire domain score and in number of satisfying sexual events (SSE) over 28 days. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale‐Revised (FSDS‐R) total score, and FSDS‐R Item 13 score. Results Compared with placebo, flibanserin led to increases in mean (standard deviation) SSE of 2.5 (4.6) vs. 1.5 (4.5), mean (standard error [SE]) FSFI desire domain score of 1.0 (0.1) vs. 0.7 (0.1), and mean (SE) FSFI total score of 5.3 (0.3) vs. 3.5 (0.3); and decreases in mean (SE) FSDS‐R Item 13 score of −1.0 (0.1) vs. −0.7 (0.1) and mean (SE) FSDS‐R total score of −9.4 (0.6) vs. −6.1 (0.6); all P ≤ 0.0001. The most frequently reported adverse events in the flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving flibanserin vs. 3.7% on placebo. Conclusion In premenopausal women with HSDD, flibanserin 100 mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo. Flibanserin was associated with significant reductions in distress associated with sexual dysfunction (FSDS‐R total score) and distress associated with low sexual desire (FSDS‐R Item 13) vs. placebo. There were no significant safety concerns associated with the use of flibanserin for 24 weeks. Katz M, DeRogatis LR, Ackerman R, Hedges P, Lesko L, Garcia M, and Sand M. Efficacy of flibanserin in women with Hypoactive Sexual Desire Disorder: Results from the BEGONIA trial. J Sex Med 2013;10:1807–1815.

Published
2013
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10. Efficacy and safety of a 21/7-active combined oral contraceptive with continuous low-dose ethinyl estradiol

Author

Ronald Ackerman, Jennifer Hsieh, Brandon Howard, Robin Kroll, Herman Weiss, Nancy Ricciotti, and Robert Feldman

Subjects
Adult, medicine.medical_specialty, Adolescent, Pregnancy Rate, media_common.quotation_subject, Ethinyl Estradiol, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Desogestrel, Pregnancy, Internal medicine, medicine, Humans, 030212 general & internal medicine, Adverse effect, Menstrual cycle, Menstrual Cycle, media_common, Gynecology, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics and Gynecology, medicine.disease, Pregnancy rate, Regimen, Contraceptives, Oral, Combined, Reproductive Medicine, Tolerability, Female, business, Pearl Index, medicine.drug
Abstract

Objective Substituting low-dose ethinyl estradiol (EE) for the hormone-free interval in combined oral contraceptives (COCs) may enhance ovarian suppression and improve tolerability. This noncomparative phase 3 study evaluated the efficacy and safety of a 21/7-active COC regimen including 21 days of desogestrel (DSG)/EE followed by 7 days of EE. Study design This multicenter, open-label, phase 3, single-arm study enrolled sexually active women aged 18–40 years at risk for pregnancy. Women received up to 1 year, or 13 consecutive 28-day cycles, of DSG 150 mcg/EE 20 mcg for 21 days and EE 10 mcg alone for 7 days. Participants kept diaries to record compliance, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index (PI) and life-table approach. Safety and tolerability were assessed primarily through reported adverse events (AEs). Results A total of 2858 women enrolled and 1680 completed the study. Forty-six pregnancies in 2401 women aged 18–35 years occurred after COC initiation and up to 7 days after last DSG/EE or EE-only tablet was taken. When cycles in which another contraceptive method was used were excluded, the PI was 2.68 [95% confidence interval (CI), 1.96–3.57]. The cumulative pregnancy rate after 1 year of treatment was 2.47% (95% CI, 1.85–3.29) for all users aged 18–35 years. When only cycles during which women considered compliant were included, the PI was 2.00 (95% CI, 1.39–2.80). AEs were similar to those seen with other oral contraceptives. Conclusions This 21/7-active DSG/EE COC with 7 days of low-dose EE was efficacious and well tolerated for pregnancy prevention. Implications statement This phase 3 open-label study demonstrated that a 21/7-active COC regimen including 21 days of DSG 150 mcg/EE 20 mcg and 7 days of EE 10 mcg was efficacious and well tolerated for pregnancy prevention.

Published
2015

11. Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

Author

Thomas E. Davis, Paul Fine, Latina Brooks, Susan S. Philip, Laura Bachman, Mathilda Barnes, Donna Mayne, Samuel Alexander, Edward W. Hook, Melanie Thompson, Nicole Quinn, Jeanne M. Marrazzo, Peter R. Kerndt, Robert Groom, Andrew De Burgh-Thomas, Patrick Clarke, Stanley Gall, Albert Tidings, Grace Daniel, Anakutty Mathews, Stephanie N. Taylor, Patrick J Horner, Timothy Spurrell, Paula Dixon, Stephen Blank, Carey Clark, Jose G. Castro, Jonathan D C Ross, Dorothy Ferguson, Philippa Moore, Eugene Anduczyk, David Ronk, Craig Dietz, Ronald Ackerman, Lydie Hazan, Lisa M. Harris, Barbara Van Der Pol, Kim Toevs, Michelle E. Meyer, Mary Jett-Goheen, Bobbie Van Der Pol, Rajul Patel, Charlotte A. Gaydos, Preeti Pancholi, and Nikole Gettings

Subjects
Microbiology (medical), Male, medicine.medical_specialty, Time Factors, Chlamydiology and Rickettsiology, Point-of-Care Systems, Gonorrhea, Chlamydia trachomatis, Urine, Biology, medicine.disease_cause, urologic and male genital diseases, Gastroenterology, Polymerase Chain Reaction, Sensitivity and Specificity, Pcr test, Internal medicine, parasitic diseases, medicine, Humans, Bacteriological Techniques, GeneXpert MTB/RIF, Chlamydia, Lymphogranuloma venereum, medicine.disease, female genital diseases and pregnancy complications, Neisseria gonorrhoeae, Molecular Diagnostic Techniques, Immunology, Lymphogranuloma Venereum, Female
Abstract

Tests for Chlamydia trachomatis and Neisseria gonorrhoeae , which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being ≥99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being ≥99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts.

Published
2013

12. Effect of once-yearly zoledronic acid on the spine and hip as measured by quantitative computed tomography: results of the HORIZON Pivotal Fracture Trial

Author

Eastell, R, Lang, T, Boonen, S, Cummings, S, Delmas, Pd, Cauley, Ja, Horowitz, Z, Kerzberg, E, Bianchi, G, Kendler, D, Leung, P, Man, Z, Mesenbrink, P, Eriksen, Ef, Black, Dm, Eduardo, Kerzberg, Zulema, Man, Carlos, Mautalen, Maria, Ridruejo, Guillermo, Tate, Jorge, Velasco, Michael, Hooper, Mark, Kotowicz, Peter, Nash, Richard, Prince, Anthony, Roberts, Philip, Sambrook, Harald, Dobnig, Gerd, Finkenstedt, Guenter, Hoefle, Klaus, Klaushofer, Martin, Pecherstorfer, Peter, Peichl, Jean, Body, Steven, Boonen, JEAN PIERRE DEVOGELAER, Piet, Geusens, Jean, Kaufman, João, Brenol, Jussara, Kochen, Rubem, Lederman, Sebastiao, Radominski, Vera, Szejnfeld, Cristiano, Zerbini, Jonathan, Adachi, Jacques, Brown, Denis, Choquette, David, Hanley, Robert, Josse, David, Kendler, Richard, Kremer, Frederic, Morin, Wojciech, Olszynski, Alexandra, Papaioannou, Chiu, Kinyuen, Baoying, Chen, Shouqing, Lin, Nohemi, Casas, Monique, Chalem, Juan, Jaller, Jose, Molina, Hannu, Aro, Jorma, Heikkinen, Heikki, Kröger, Lasse, Mäkinen, Juha, Saltevo, Jorma, Salmi, Matti, Välimäki, CLAUDE LAURENT BENHAMOU, Pierre, Delmas, Patrice, Fardellone, Georges, Werhya, Bruno, Allolio, Dieter, Felsenberg, Joachim, Happ, Manfred, Hartard, Johannes, Hensen, Peter, Kaps, Joern, Kekow, Ruediger, Moericke, Bernd, Ortloff, Peter, Schneider, Siegfried, Wassenberg, PING CHUNG LEUNG, Adam, Balogh, Bela, Gomor, Tibor, Hidvégi, Laszlo, Koranyi, Péter, Lakatos, Gyula, Poór, Zsolt, Tulassay, RIVKA DRESNER POLLAK, Varda, Eshed, JOSEPH FOLDES, A., SOPHIA ISH SHALOM, Iris, Vered, Mordechai, Weiss, Silvano, Adami, Antonella, Barone, Gerolamo, Bianchi, Giannini, Sandro, GIOVANNI CARLO ISAIA, Luisetto, Giovanni, Salvatore, Minisola, Nicola, Molea, Ranuccio, Nuti, Sergio, Ortolani, Mario, Passeri, Alessandro, Rubinacci, Bruno, Seriolo, Luigi, Sinigaglia, WOONG HWAN CHOI, MOO II KANG, GHI SU KIM, HYE SOON KIM, YONG KI KIM, SUNG KIL LIM, HO YOUNG SON, HYUN KOO YOON, Carlos, Abud, Pedro, Garcia, Salomon, Jasqui, Luis, Ochoa, Javier, Orozco, Javier, Santos, Ian, Reid, Sigbjørn, Elle, Johan, Halse, Arne, Høiseth, Hans, Olav, HØIVIK INGUN RØED, Arne, Skag, Jacob, Stakkestad, Unni, Syversen, Janusz, Badurski, Edward, Czerwinski, Roman, Lorenc, EWA MARCINOWSKA SUCHOWIERSKA, Andrzej, Sawicki, Jerzy, Supronik, Eduard, Ailamazyan, Lidiya, Benevolenskaya, Alexander, Dreval, Leonid, Dvoretsky, Raisa, Dyomina, Vadim, Mazurov, Galina, Melnichenko, Ashot, Mkrtoumyan, ALEXANDER ORLOV MOROZOV, Olga, Ostroumova, Eduard, Pikhlak, Tatiana, Shemerovskaya, Nadezhda, Shostak, Irina, Skripnikova, Vera, Smetnik, Evgenia, Tsyrlina, Galina, Usova, Alsu, Zalevskaya, Irina, Zazerskaya, Eugeny, Zotkin, Osten, Ljunggren, Johan, Lofgren, Mats, Palmér, Maria, Saaf, Martin, Stenström, Paul, Hasler, Olivier, Lamy, Kurt, Lippuner, Claude, Merlin, René, Rizzoli, Robert, Theiler, Alan, Tyndall, Daniel, Uebelhart, JUNG FU CHEN, PO QUANG CHEN, LIN SHOW CHIN, JAWL SHAN HWANG, TZAY SHING YANG, Mayuree, Jirapinyo, Rojanasthien, Sattaya, Sutin, Sriussadaporn, Soontrapa, Supasin, Nimit, Taechakraichana, Kittisak, Wilawan, Hugh, Donnachie, Richard, Eastell, William, Fraser, Alistair, Mclellan, David, Reid, John, Abruzzo, Ronald, Ackerman, Robert, Adler, John, Aloia, Charles, Birbara, Barbara, Bode, Henry, Bone, Donald, Brandon, Jane, Cauley, Felicia, Cosman, Daniel, Dionne, Robert, Downs, James, Dreyfus, RONALD EMKEY, VICTOR E. L. I. N. O. F. F., Joseph, Fanciullo, Darrell, Fiske, Palmieri, Genaro, Gollapudi, M., Richard, Gordon, James, Hennessey, Paul, Howard, Karen, Johnson, Conrad, Johnston, Risa, Kagan, Shelly, Kafka, Jeffrey, Kaine, Terry, Klein, William, Koltun, Meryl, Leboff, Bruce, Levine, MICHAEL LEWIECKI, E., CORA ELIZABETH LEWIS, Angelo, Licata, Michael, Lillestol, Barry, Lubin, Raymond, Malamet, Antoinette, Mangione, Velimir, Matkovic, Daksha, Mehta, Paul, Miller, Sam, Miller, Murphy, FREDERIK T., Susan, Nattrass, David, Podlecki, Christopher, Recknor, Clifford, Rosen, Daniel, Rowe, Robert, Rude, Thomas, Schnitzer, Yvonne, Sherrer, Stuart, Silverman, Kenna, Stephenson, Barbara, Troupin, Joseph, Tucci, Reina, Villareal, Nelson, Watts, Richard, Weinstein, Robert, Weinstein, Michael, Weitz, and Richard, White

Subjects
musculoskeletal diseases, medicine.medical_specialty, Compressive Strength, Bone density, Endocrinology, Diabetes and Metabolism, Osteoporosis, Lumbar vertebrae, Zoledronic Acid, Article, Drug Administration Schedule, Bone densitometry, Absorptiometry, Photon, Clinical trials, Bone Density, Humans, Medicine, Quantitative computed tomography, Osteoporosis, Postmenopausal, Aged, Aged, 80 and over, Bone mineral, Lumbar Vertebrae, Bone Density Conservation Agents, Diphosphonates, medicine.diagnostic_test, Femur Neck, business.industry, musculoskeletal, neural, and ocular physiology, Imidazoles, Bone QCT, Bisphosphonates, musculoskeletal system, medicine.disease, body regions, Zoledronic acid, medicine.anatomical_structure, Female, Hip Joint, sense organs, Radiology, Tomography, X-Ray Computed, business, Densitometry, Follow-Up Studies, medicine.drug
Abstract

Changes in bone mineral density and bone strength following treatment with zoledronic acid (ZOL) were measured by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA). ZOL treatment increased spine and hip BMD vs placebo, assessed by QCT and DXA. Changes in trabecular bone resulted in increased bone strength.To investigate bone mineral density (BMD) changes in trabecular and cortical bone, estimated by quantitative computed analysis (QCT) or dual-energy X-ray absorptiometry (DXA), and whether zoledronic acid 5 mg (ZOL) affects bone strength.In 233 women from a randomized, controlled trial of once-yearly ZOL, lumbar spine, total hip, femoral neck, and trochanter were assessed by DXA and QCT (baseline, Month 36). Mean percentage changes from baseline and between-treatment differences (ZOL vs placebo, t-test) were evaluated.Mean between-treatment differences for lumbar spine BMD were significant by DXA (7.0%, p0.01) and QCT (5.7%, p0.0001). Between-treatment differences were significant for trabecular spine (p = 0.0017) [non-parametric test], trabecular trochanter (10.7%, p0.0001), total hip (10.8%, p0.0001), and compressive strength indices at femoral neck (8.6%, p = 0.0001), and trochanter (14.1%, p0.0001).Once-yearly ZOL increased hip and spine BMD vs placebo, assessed by QCT vs DXA. Changes in trabecular bone resulted in increased indices of compressive strength.

Published
2010
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13. Acyl CoA and lipid synthesis from ketone bodies by the extramitochondrial fraction of hepatoma tissue

Author

Ronald Ackerman, Leslie Anne Hildebrandt, Earl Shrago, Terry Spennetta, and Charles E. Elson

Subjects
Radioisotope Dilution Technique, Biophysics, Hydroxybutyrates, Ketone Bodies, Biochemistry, Cell-free system, Acetoacetates, chemistry.chemical_compound, Acyl-CoA, Liver Neoplasms, Experimental, 3-Hydroxybutyric Acid, Animals, Carbon Radioisotopes, Citrates, Molecular Biology, chemistry.chemical_classification, biology, Cell-Free System, Chemistry, Cholesterol, Lipid metabolism, Cell Biology, Lipid Metabolism, Enzyme assay, Mitochondria, Rats, Kinetics, Enzyme, Liver, biology.protein, Ketone bodies, lipids (amino acids, peptides, and proteins), Acyl Coenzyme A, Subcellular Fractions
Abstract

The compartmentation of the pathway for the synthesis of lipids from ketone bodies was examined in a cell free, post-mitochondrial supernatant fraction of malignant Morris hepatoma 7777 tissue. A fortified supernatant system effectively incorporated radioactive D(-)-3-hydroxybutyrate and acetoacetate into cholesterol and fatty acids, and both ketone bodies were directly converted to their CoA thioesters. Furthermore, a microsome-free (100,000 x g) cytosolic fraction was also able to acylate 3-hydroxybutyrate to 3-hydroxybutyryl CoA. No previous identification of this enzyme activity has been described. These results which characterize a distinct extramitochondrial pathway for conversion of 3-hydroxybutyrate as well as acetoacetate into lipids also suggest the possibility of a previously undetected enzymatic activity for utilization of this ketone body.

Published
1996

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