Author: "Malkin, Elissa" - Searchworks@Jio Institute Digital Library Search Results

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1. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.

Author: Branche, Angela, Rouphael, Nadine, Diemert, David, Falsey, Ann, Losada, Cecilia, Baden, Lindsey, Frey, Sharon, Whitaker, Jennifer, Anderson, Evan, Walter, Emmanuel, Novak, Richard, Rupp, Richard, Jackson, Lisa, Babu, Tara, Kottkamp, Angelica, Luetkemeyer, Anne, Immergluck, Lilly, Presti, Rachel, Bäcker, Martín, Winokur, Patricia, Mahgoub, Siham, Goepfert, Paul, Fusco, Dahlene, Malkin, Elissa, Bethony, Jeffrey, Walsh, Edward, Graciaa, Daniel, Samaha, Hady, Sherman, Amy, Walsh, Stephen, Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana, Kamidani, Satoshi, Smith, Michael, Ladner, Benjamin, Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert, Mulligan, Mark, Lyke, Kirsten, Posavad, Christine, Meagher, Megan, Stephens, David, Neuzil, Kathleen, Abebe, Kuleni, Hill, Heather, Albert, Jim, Telu, Kalyani, Mu, Jinjian, Lewis, Teri, Giebeig, Lisa, Eaton, Amanda, Netzl, Antonia, Wilks, Samuel, Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Montefiori, David, Makowski, Mat, Smith, Derek, Nayak, Seema, Roberts, Paul, Beigel, John, Little, Susan, and Martin, Thomas
Subjects: Humans, COVID-19 Vaccines, SARS-CoV-2, COVID-19, Broadly Neutralizing Antibodies
Abstract: Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID50 titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: NCT05289037 .
Published: 2023

2. 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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3. Ultrasound-guided lymph node fine-needle aspiration for evaluating post-vaccination germinal center responses in humans

Author: Scholte, Larissa L.S., primary, Leggat, David J., additional, Cohen, Kristen W., additional, Hoeweler, Lara, additional, Erwin, Guacyara C., additional, Rahaman, Farhard, additional, Lombardo, Angela, additional, Philiponis, Vincent, additional, Laufer, Dagna S., additional, Siefers, Heather, additional, Ruppel, Alexis M., additional, Brand, Joshua, additional, Maenza, Janine, additional, Bronson, Rhi, additional, Prabhakaran, Madhu, additional, Jean-Baptiste, Jalen, additional, Kolokythas, Orpheus, additional, Desrosiers, Aimee A., additional, Thoreson, Caroline K., additional, Heit, Antje, additional, Khati, Nadia J., additional, Malkin, Elissa, additional, McElrath, M. Juliana, additional, McDermott, Adrian B., additional, Schief, William R., additional, Diemert, David, additional, and Bethony, Jeffrey M., additional
Published: 2023
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4. 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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5. Bivalent and Monovalent SARS-CoV-2 Variant Vaccine Boosters Improve coverage of the known Antigenic Landscape: Results of the COVID-19 Variant Immunologic Landscape (COVAIL) Trial

Author: Branche, Angela, primary, Rouphael, Nadine, additional, Diemert, David, additional, Falsey, Ann, additional, Losada, Cecilia, additional, Baden, Lindsey (R), additional, Frey, Sharon, additional, Whitaker, Jennifer, additional, Little, Susan, additional, Anderson, Evan, additional, Walter, Emmanuel, additional, Novak, Richard, additional, Rupp, Richard, additional, Jackson, Lisa, additional, Babu, Tara, additional, Kottkamp, Angelica, additional, Luetkemeyer, Annie, additional, Immergluck, Lilly, additional, Presti, Rachel, additional, Backer, Martin, additional, Winokur, Patricia, additional, Mahgoub, Siham, additional, Goepfert, Paul, additional, Fusco, Dahlene, additional, Malkin, Elissa, additional, Bethony, Jeff, additional, Walsh, Edward, additional, Graciaa, Daniel, additional, Samaha, Hady, additional, Sherman, Amy, additional, Walsh, Stephen, additional, Abate, Getahun, additional, Oikonomopoulou, Zacharoula, additional, Sahly, Hana El, additional, Martin, Thomas, additional, Kamidani, Satoshi, additional, Smith, Michael, additional, Ladner, Benjamin, additional, Porterfield, Laura, additional, Dunstan, Maya, additional, Wald, Anna, additional, Davis, Tamia, additional, Atmar, Robert, additional, Mulligan, Mark, additional, Lyke, Kirsten, additional, Posavad, Christine, additional, Meagher, Megan, additional, Stephens, David, additional, Neuzil, Kathleen, additional, Abebe, Kuleni, additional, Hill, Heather, additional, Albert, Jim, additional, Telu, Kalyani, additional, Mu, Jinjian, additional, Lewis, Teri, additional, Giebeig, Lisa, additional, Eaton, Amanda, additional, Netzl, Antonia, additional, Wilks, Sam, additional, Tureli, Sina, additional, Makhene, Mamodikoe, additional, Crandon, Sonja, additional, Montefiori, David, additional, Makowski, Mat, additional, Smith, Derek, additional, Nayak, Seema, additional, Roberts, Paul, additional, and Beigel, John, additional
Published: 2023
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6. SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses

Author: Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C.S., Rostad, Christina A., Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Lee, Marina, Nayak, Seema U., Montefiori, David C., Makowski, Mat, Smith, Derek J., Roberts, Paul C., and Beigel, John H.
Subjects: Article
Abstract: BackgroundProtection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines.MethodsThis phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a SARS-CoV-2 primary series and a single boost. Eligible participants were randomized to one of six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), Omicron BA.1+Beta (1 or 2 doses), Omicron BA.1+Delta, Omicron BA.1 monovalent, and Omicron BA.1+Prototype. Neutralization antibody titers (ID50) were assessed for D614G, Delta, Beta and Omicron BA.1 variants and Omicron BA.2.12.1 and BA.4/BA.5 subvariants 15 days after vaccination.ResultsFrom March 30 to May 6, 2022, 597 participants were randomized and vaccinated. Median age was 53 years, and 20% had a prior SARS-CoV-2 infection. All vaccines were safe and well-tolerated. Day 15 geometric mean titers (GMT) against D614G were similar across arms and ages, and higher with prior infection. For uninfected participants, Day 15 Omicron BA.1 GMTs were similar across Omicron-containing vaccine arms (3724-4561) and higher than Prototype (1,997 [95%CI:1,482-2,692]). The Omicron BA.1 monovalent and Omicron BA.1+Prototype vaccines induced a geometric mean ratio (GMR) to Prototype for Omicron BA.1 of 2.03 (97.5%CI:1.37-3.00) and 1.56 (97.5%CI:1.06-2.31), respectively. A subset of samples from uninfected participants in four arms were also tested in a different laboratory at Day 15 for neutralizing antibody titers to D614G and Omicron subvariants BA.1, BA.2.12.2 and BA.4/BA.5. Omicron BA.4/BA.5 GMTs were approximately one third BA.1 GMTs (Prototype 517 [95%CI:324-826] vs. 1503 [95%CI:949-2381]; Omicron BA.1+Beta 628 [95%CI:367-1,074] vs. 2125 [95%CI:1139-3965]; Omicron BA.1+Delta 765 [95%CI:443-1,322] vs. 2242 [95%CI:1218-4128] and Omicron BA.1+Prototype 635 [95%CI:447-903] vs. 1972 [95%CI:1337-2907).ConclusionsHigher Omicron BA.1 titers were observed with Omicron-containing vaccines compared to Prototype vaccine and titers against Omicron BA.4/BA.5 were lower than against BA.1 for all candidate vaccines.Clinicaltrials.govNCT05289037
Published: 2022

7. Quantitative Detection of Plasmodium falciparum DNA in Saliva, Blood, and Urine

Author: Nwakanma, Davis C., Gomez-Escobar, Natalia, Walther, Michael, Crazier, Sarah, Dubovsky, Filip, Malkin, Elissa, Locke, Emily, and Conway, David J.
Published: 2009
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8. Molecular Markers for Failure of Sulfadoxine-Pyrimethamine and Chlorproguanil-Dapsone Treatment of Plasmodium falciparum Malaria

Author: Kublin, James G., Dzinjalamala, Fraction K., Kamwendo, Deborah D., Malkin, Elissa M., Cortese, Joseph F., Martino, Lisa M., Mukadam, Rabia A. G., Rogerson, Stephen J., Lescano, Andres G., Molyneux, Malcolm E., Winstanley, Peter A., Chimpeni, Phillips, Taylor, Terrie E., and Plowe, Christopher V.
Published: 2002

9. A Phase 1 trial of PfCP2.9: An AMA1/MSP1 chimeric recombinant protein vaccine for Plasmodium falciparum malaria

Author: Malkin, Elissa, Hu, Jinhong, Li, Zhen, Chen, Zhihui, Bi, Xinling, Reed, Zarifah, Dubovsky, Filip, Liu, Jian, Wang, Qiang, Pan, Xuegong, Chen, Tom, Giersing, Birgitte, Xu, Yu, Kang, Xin, Gu, Jun, Shen, Qian, Tucker, Kathryn, Tierney, Eveline, Pan, Weiqing, Long, Carole, and Cao, Zhifang
Published: 2008
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10. Translational sciences approach to RSV vaccine development

Author: Kurzweil, Vanessa, Tang, Roderick, Galinski, Mark, Wang, Kathy, Zuo, Fengrong, Cherukuri, Anu, Gasser, Robert A, Jr, Malkin, Elissa, Sifakis, Frangiscos, Mendel, Dirk B, and Esser, Mark T
Published: 2013
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11. Progress towards the development of malaria vaccines

Author: Malkin, Elissa, Dubovsky, Filip, and Moree, Melinda
Published: 2006
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12. Contributors

Author: Abrignani, Sergio, primary, Anderson, Teresa A., additional, Atkinson, William L., additional, Baker, Carol J., additional, Barrett, P. Noel, additional, Barnett, Elizabeth D., additional, Barry, Eileen M., additional, Baylor, Norman W., additional, Bell, Beth P., additional, Belshe, Robert B., additional, Berinstein, Neil L., additional, Bethony, Jeffrey M., additional, Black, Steven, additional, Bogaerts, Hugues H., additional, Borio, Luciana L., additional, Borrow, Ray, additional, Brachman, Philip S., additional, Bridges, Carolyn B., additional, Caplan, Arthur L., additional, Cetron, Martin S., additional, Chandran, Aruna, additional, Clark, H. Fred, additional, Cochi, Stephen L., additional, Cox, Nancy J., additional, Cutts, Felicity T., additional, Daum, Robert S., additional, Davis, Joanne E., additional, Davis, Robert L., additional, Dayan, Gustavo H., additional, Decker, Michael D., additional, Dietz, Vance, additional, Douglas, R. Gordon, additional, Dubovsky, Filip, additional, Edwards, Kathryn M., additional, Egan, William, additional, Ehrlich, Hartmut J., additional, Ellis, Ronald W., additional, Emerson, Suzanne U., additional, Eskola, Juhani, additional, Evans, Geoffrey, additional, Feinstone, Stephen M., additional, Fine, Paul E.M., additional, Finn, Theresa M., additional, Fiore, Anthony E., additional, Frazer, Ian H., additional, Friedlander, Arthur M., additional, Gaydos, Charlotte A., additional, Gershon, Anne A., additional, Girard, Marc P., additional, Gomez, Phillip L., additional, Grabenstein, John D., additional, Granoff, Dan M., additional, Gray, Gregory C., additional, Gust, Deborah, additional, Haagmans, Bart L., additional, Hadler, Stephen C., additional, Halsey, Neal A., additional, Halstead, Scott B., additional, Harrison, Lee H., additional, Healy, C. Mary, additional, Hem, Stanley L., additional, Henderson, Donald A., additional, Hinman, Alan R., additional, Hotez, Peter J., additional, Houghton, Michael, additional, Jackson, Lisa A., additional, Jacobson, Julie, additional, Karron, Ruth A., additional, Katz, Jaqueline M., additional, Kemble, George, additional, Kew, Olen M., additional, Koff, Wayne C., additional, Kotloff, Karen L., additional, Koprowski, Hilary, additional, Kozarsky, Phyllis E., additional, Kretsinger, Katrina, additional, Kroger, Andrew L., additional, Levandowski, Roland A., additional, Levin, Myron J., additional, Levine, Emily Marcus, additional, Levine, Myron M., additional, Ljungman, Per, additional, Lowy, Douglas R., additional, Malkin, Elissa, additional, Maassab, Husein F., additional, Mast, Eric E., additional, Mendelman, Paul M., additional, Midthun, Karen, additional, Miller, Mark A., additional, Monath, Thomas P., additional, Moss, Denis J., additional, Moss, William J., additional, Mulholland, Kim, additional, Nabel, Gary J., additional, Nataro, James P., additional, Neuzil, Kathleen M., additional, Offit, Paul A., additional, Okwo-Bele, Jean-Marie, additional, Orenstein, Walter A., additional, Orme, Ian M., additional, Osterhaus, Albert D.M.E., additional, Papania, Mark J., additional, Parashar, Umesh D., additional, Pickering, Larry K., additional, Pittman, Phillip, additional, Plotkin, Stanley A., additional, Plotkin, Susan L., additional, Purcell, Robert H., additional, Reef, Susan E., additional, Robinson, James M., additional, Rodewald, Lance E., additional, Rogalewicz, Joseph A., additional, Roper, Martha H., additional, Rubin, Steven A., additional, Rupprecht, Charles E., additional, Rutala, William A., additional, Sack, David A., additional, Sadoff, Jerald C., additional, Saindon, Elizabeth H., additional, Salisbury, David M., additional, Samant, Vijay B., additional, Santosham, Mathuram, additional, Schiller, John T., additional, Schuchat, Anne, additional, Schwartz, Jason L., additional, Seward, Jane F., additional, Shinefield, Henry, additional, Siber, George R., additional, Siegrist, Claire-Anne, additional, Simpson, Andrew J., additional, Smith, Kim Connelly, additional, Spaner, David, additional, Spika, John S., additional, Stanberry, Lawrence R., additional, Starke, Jeffrey R., additional, Steere, Allen C., additional, Steffen, Robert, additional, Stoddard, Jeffrey J., additional, Strebel, Peter M., additional, Sullivan, Nancy J., additional, Sutter, Roland W., additional, Tacket, Carol O., additional, Takahashi, Michiaki, additional, Teuwen, Dirk E., additional, Titball, Richard W., additional, Tsai, Theodore F., additional, Vaughn, David W., additional, Vidor, Emmanuel, additional, Vitek, Charles R., additional, Vogel, Frederick R., additional, Walker, Robert, additional, Ward, John W., additional, Ward, Richard L., additional, Wassilak, Steven G.F., additional, Watt, James P., additional, Weber, David J., additional, Weniger, Bruce G., additional, Wexler, Deborah L., additional, Wharton, Melinda, additional, Whitney, Cynthia, additional, Williamson, E. Diane, additional, and Yi Xu, Zhi, additional
Published: 2008
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13. Malaria vaccines

Author: Dubovsky, Filip, primary and Malkin, Elissa, additional
Published: 2008
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14. Phase 1 vaccine trial of Pvs25H: a transmission blocking vaccine for Plasmodium vivax malaria

Author: Malkin, Elissa M., Durbin, Anna P., Diemert, David J., Sattabongkot, Jetsumon, Wu, Yimin, Miura, Kazutoyo, Long, Carole A., Lambert, Lynn, Miles, Aaron P., Wang, Jin, Stowers, Anthony, Miller, Louis H., and Saul, Allan
Published: 2005
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15. Pseudotumor Cerebri Secondary to Minocycline Intake

Author: Ang, Earl Robert G., Zimmerman, J. C. Chava, and Malkin, Elissa
Published: 2002

16. Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya

Author: Ogutu, Bernhards R., Apollo, Odika J., McKinney, Denise, Okoth, Willis, Siangla, Joram, Dubovsky, Filip, Tucker, Kathryn, Waitumbi, John N., Diggs, Carter, Wittes, Janet, Malkin, Elissa, Leach, Amanda J., Soisson, Lorraine A., Milman, Jessica B., Otieno, Lucas, Holland, Carolyn A., Polhemus, Mark, Remich, Shon A., Ockenhouse, Christian F., MSP-1 Malaria Vaccine Working Group, et al., Ogutu, Bernhards R., Apollo, Odika J., McKinney, Denise, Okoth, Willis, Siangla, Joram, Dubovsky, Filip, Tucker, Kathryn, Waitumbi, John N., Diggs, Carter, Wittes, Janet, Malkin, Elissa, Leach, Amanda J., Soisson, Lorraine A., Milman, Jessica B., Otieno, Lucas, Holland, Carolyn A., Polhemus, Mark, Remich, Shon A., Ockenhouse, Christian F., MSP-1 Malaria Vaccine Working Group, and et al.
Abstract: Objective:The antigen, falciparum malaria protein 1 (FMP1), represents the 42-kDa C-terminal fragment of merozoite surface protein-1 (MSP-1) of the 3D7 clone of P. falciparum. Formulated with AS02 (a proprietary Adjuvant System), it constitutes the FMP1/AS02 candidate malaria vaccine. We evaluated this vaccine's safety, immunogenicity, and efficacy in African children.Methods:A randomised, double-blind, Phase IIb, comparator-controlled trial.The trial was conducted in 13 field stations of one mile radii within Kombewa Division, Nyanza Province, Western Kenya, an area of holoendemic transmission of P. falciparum. We enrolled 400 children aged 12–47 months in general good health.Children were randomised in a 1:1 fashion to receive either FMP1/AS02 (50 µg) or Rabipur® rabies vaccine. Vaccinations were administered on a 0, 1, and 2 month schedule. The primary study endpoint was time to first clinical episode of P. falciparum malaria (temperature ≥37.5°C with asexual parasitaemia of ≥50,000 parasites/µL of blood) occurring between 14 days and six months after a third dose. Case detection was both active and passive. Safety and immunogenicity were evaluated for eight months after first immunisations; vaccine efficacy (VE) was measured over a six-month period following third vaccinations.Results:374 of 400 children received all three doses and completed six months of follow-up. FMP1/AS02 had a good safety profile and was well-tolerated but more reactogenic than the comparator. Geometric mean anti-MSP-142 antibody concentrations increased from1.3 µg/mL to 27.3 µg/mL in the FMP1/AS02 recipients, but were unchanged in controls. 97 children in the FMP1/AS02 group and 98 controls had a primary endpoint episode. Overall VE was 5.1% (95% CI: −26% to +28%; p-value = 0.7).Conclusions:FMP1/AS02 is not a promising candidate for further development as a monovalent malaria vaccine. Future MSP-142 vaccine development should focus on othe
Published: 2009

17. Template protocol for clinical trials investigating vaccines—Focus on safety elements

Author: Bonhoeffer, Jan, primary, Imoukhuede, Egeruan B., additional, Aldrovandi, Grace, additional, Bachtiar, Novilia S., additional, Chan, Eng-Soon, additional, Chang, Soju, additional, Chen, Robert T., additional, Fernandopulle, Rohini, additional, Goldenthal, Karen L., additional, Heffelfinger, James D., additional, Hossain, Shah, additional, Jevaji, Indira, additional, Khamesipour, Ali, additional, Kochhar, Sonali, additional, Makhene, Mamodikoe, additional, Malkin, Elissa, additional, Nalin, David, additional, Prevots, Rebecca, additional, Ramasamy, Ranjan, additional, Sellers, Sarah, additional, Vekemans, Johan, additional, Walker, Kenneth B., additional, Wilson, Pam, additional, Wong, Virginia, additional, Zaman, Khalequz, additional, and Heininger, Ulrich, additional
Published: 2013
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18. Safety and Immunogenicity of a Live Attenuated RSV Vaccine in Healthy RSV-Seronegative Children 5 to 24 Months of Age

Author: Malkin, Elissa, primary, Yogev, Ram, additional, Abughali, Nazha, additional, Sliman, Joseph, additional, Wang, C. Kathy, additional, Zuo, Fengrong, additional, Yang, Chin-Fen, additional, Eickhoff, Mark, additional, Esser, Mark T., additional, Tang, Roderick S., additional, and Dubovsky, Filip, additional
Published: 2013
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19. Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine

Author: Yang, Chin-Fen, primary, Wang, C. Kathy, additional, Malkin, Elissa, additional, Schickli, Jeanne H., additional, Shambaugh, Cindy, additional, Zuo, Fengrong, additional, Galinski, Mark S., additional, Dubovsky, Filip, additional, and Tang, Roderick S., additional
Published: 2013
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20. Chapter 52 - Malaria vaccines

Author: Dubovsky, Filip and Malkin, Elissa
Published: 2008
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21. Phase 1 Study of the Safety and Immunogenicity of a Live, Attenuated Respiratory Syncytial Virus and Parainfluenza Virus Type 3 Vaccine in Seronegative Children

Author: Bernstein, David I., primary, Malkin, Elissa, additional, Abughali, Nazha, additional, Falloon, Judith, additional, Yi, Tingting, additional, and Dubovsky, Filip, additional
Published: 2012
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22. Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial

Author: Benkeser, David, Montefiori, David C., McDermott, Adrian B., Fong, Youyi, Janes, Holly E., Deng, Weiping, Zhou, Honghong, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Flach, Britta, Lin, Bob C., O’Connell, Sarah, McDanal, Charlene, Eaton, Amanda, Sarzotti-Kelsoe, Marcella, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Kenny, Avi, Carone, Marco, Williamson, Brian D., Garver, Jennifer, Altonen, Erin, Rudge, Thomas, Huynh, Chuong, Miller, Jacqueline, El Sahly, Hana M., Baden, Lindsey R., Frey, Sharon, Malkin, Elissa, Spector, Stephen A., Andrasik, Michele P., Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Carpp, Lindsay N., Pajon, Rolando, Follmann, Dean, Donis, Ruben O., Koup, Richard A., and Gilbert, Peter B.
Abstract: The best assay or marker to define mRNA-1273 vaccine–induced antibodies as a correlate of protection (CoP) is unclear. In the COVE trial, participants received two doses of the mRNA-1273 COVID-19 vaccine or placebo. We previously assessed IgG binding antibodies to the spike protein (spike IgG) or receptor binding domain (RBD IgG) and pseudovirus neutralizing antibody 50 or 80% inhibitory dilution titer measured on day 29 or day 57, as correlates of risk (CoRs) and CoPs against symptomatic COVID-19 over 4 months after dose. Here, we assessed a new marker, live virus 50% microneutralization titer (LV-MN50), and compared and combined markers in multivariable analyses. LV-MN50was an inverse CoR, with a hazard ratio of 0.39 (95% confidence interval, 0.19 to 0.83) at day 29 and 0.51 (95% confidence interval, 0.25 to 1.04) at day 57 per 10-fold increase. In multivariable analyses, pseudovirus neutralization titers and anti-spike binding antibodies performed best as CoRs; combining antibody markers did not improve correlates. Pseudovirus neutralization titer was the strongest independent correlate in a multivariable model. Overall, these results supported pseudovirus neutralizing and binding antibody assays as CoRs and CoPs, with the live virus assay as a weaker correlate in this sample set. Day 29 markers performed as well as day 57 markers as CoPs, which could accelerate immunogenicity and immunobridging studies.
Published: 2023
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23. A Phase 1 Trial of MSP2-C1, a Blood-Stage Malaria Vaccine Containing 2 Isoforms of MSP2 Formulated with Montanide® ISA 720

Author: McCarthy, James S., primary, Marjason, Joanne, additional, Elliott, Suzanne, additional, Fahey, Paul, additional, Bang, Gilles, additional, Malkin, Elissa, additional, Tierney, Eveline, additional, Aked-Hurditch, Hayley, additional, Adda, Christopher, additional, Cross, Nadia, additional, Richards, Jack S., additional, Fowkes, Freya J. I., additional, Boyle, Michelle J., additional, Long, Carole, additional, Druilhe, Pierre, additional, Beeson, James G., additional, and Anders, Robin F., additional
Published: 2011
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24. Safety and Immunogenicity Following Administration of a Live, Attenuated Monovalent 2009 H1N1 Influenza Vaccine to Children and Adults in Two Randomized Controlled Trials

Author: Mallory, Raburn M., primary, Malkin, Elissa, additional, Ambrose, Christopher S., additional, Bellamy, Terramika, additional, Shi, Li, additional, Yi, Tingting, additional, Jones, Taff, additional, Kemble, George, additional, and Dubovsky, Filip, additional
Published: 2010
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25. Recombinant Liver Stage Antigen-1 (LSA-1) formulated with AS01 or AS02 is safe, elicits high titer antibody and induces IFN-γ/IL-2 CD4+ T cells but does not protect against experimental Plasmodium falciparum infection

Author: Cummings, James F., primary, Spring, Michele D., additional, Schwenk, Robert J., additional, Ockenhouse, Christian F., additional, Kester, Kent E., additional, Polhemus, Mark E., additional, Walsh, Douglas S., additional, Yoon, In-Kyu, additional, Prosperi, Christine, additional, Juompan, Laure Y., additional, Lanar, David E., additional, Krzych, Urszula, additional, Hall, B. Ted, additional, Ware, Lisa A., additional, Stewart, V. Ann, additional, Williams, Jack, additional, Dowler, Megan, additional, Nielsen, Robin K., additional, Hillier, Collette J., additional, Giersing, Birgitte K., additional, Dubovsky, Filip, additional, Malkin, Elissa, additional, Tucker, Kathryn, additional, Dubois, Marie-Claude, additional, Cohen, Joe D., additional, Ballou, W. Ripley, additional, and Jr, D. Gray Heppner, additional
Published: 2010
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26. Phase 1 safety and immunogenicity trial of the Plasmodium falciparum blood-stage malaria vaccine AMA1-C1/ISA 720 in Australian adults

Author: Pierce, Mark A., primary, Ellis, Ruth D., additional, Martin, Laura B., additional, Malkin, Elissa, additional, Tierney, Eveline, additional, Miura, Kazutoyo, additional, Fay, Michael P., additional, Marjason, Joanne, additional, Elliott, Suzanne L., additional, Mullen, Gregory E.D., additional, Rausch, Kelly, additional, Zhu, Daming, additional, Long, Carole A., additional, and Miller, Louis H., additional
Published: 2010
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27. Quantitative Detection ofPlasmodium falciparumDNA in Saliva, Blood, and Urine

Author: Nwakanma, Davis C., primary, Gomez‐Escobar, Natalia, additional, Walther, Michael, additional, Crozier, Sarah, additional, Dubovsky, Filip, additional, Malkin, Elissa, additional, Locke, Emily, additional, and Conway, David J., additional
Published: 2009
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28. Phase 1/2a Study of the Malaria Vaccine Candidate Apical Membrane Antigen-1 (AMA-1) Administered in Adjuvant System AS01B or AS02A

Author: Spring, Michele D., primary, Cummings, James F., additional, Ockenhouse, Christian F., additional, Dutta, Sheetij, additional, Reidler, Randall, additional, Angov, Evelina, additional, Bergmann-Leitner, Elke, additional, Stewart, V. Ann, additional, Bittner, Stacey, additional, Juompan, Laure, additional, Kortepeter, Mark G., additional, Nielsen, Robin, additional, Krzych, Urszula, additional, Tierney, Ev, additional, Ware, Lisa A., additional, Dowler, Megan, additional, Hermsen, Cornelus C., additional, Sauerwein, Robert W., additional, de Vlas, Sake J., additional, Ofori-Anyinam, Opokua, additional, Lanar, David E., additional, Williams, Jack L., additional, Kester, Kent E., additional, Tucker, Kathryn, additional, Shi, Meng, additional, Malkin, Elissa, additional, Long, Carole, additional, Diggs, Carter L., additional, Soisson, Lorraine, additional, Dubois, Marie-Claude, additional, Ballou, W. Ripley, additional, Cohen, Joe, additional, and Heppner, D. Gray, additional
Published: 2009
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29. The TLR9 Ligand CpG Promotes the Acquisition of Plasmodium falciparum-Specific Memory B Cells in Malaria-Naive Individuals

Author: Crompton, Peter D., primary, Mircetic, Marko, additional, Weiss, Greta, additional, Baughman, Amy, additional, Huang, Chiung-Yu, additional, Topham, David J., additional, Treanor, John J., additional, Sanz, Iñaki, additional, Lee, F. Eun-Hyung, additional, Durbin, Anna P., additional, Miura, Kazutoyo, additional, Narum, David L., additional, Ellis, Ruth D., additional, Malkin, Elissa, additional, Mullen, Gregory E. D., additional, Miller, Louis H., additional, Martin, Laura B., additional, and Pierce, Susan K., additional
Published: 2009
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30. Comparison of Biological Activity of Human Anti-Apical Membrane Antigen-1 Antibodies Induced by Natural Infection and Vaccination

Author: Miura, Kazutoyo, primary, Zhou, Hong, additional, Moretz, Samuel E., additional, Diouf, Ababacar, additional, Thera, Mahamadou A., additional, Dolo, Amagana, additional, Doumbo, Ogobara, additional, Malkin, Elissa, additional, Diemert, David, additional, Miller, Louis H., additional, Mullen, Gregory E. D., additional, and Long, Carole A., additional
Published: 2008
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31. Phase 1 Trial of AMA1-C1/Alhydrogel plus CPG 7909: An Asexual Blood-Stage Vaccine for Plasmodium falciparum Malaria

Author: Mullen, Gregory E. D., primary, Ellis, Ruth D., additional, Miura, Kazutoyo, additional, Malkin, Elissa, additional, Nolan, Caroline, additional, Hay, Mhorag, additional, Fay, Michael P., additional, Saul, Allan, additional, Zhu, Daming, additional, Rausch, Kelly, additional, Moretz, Samuel, additional, Zhou, Hong, additional, Long, Carole A., additional, Miller, Louis H., additional, and Treanor, John, additional
Published: 2008
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32. Phase 1 Trial of Malaria Transmission Blocking Vaccine Candidates Pfs25 and Pvs25 Formulated with Montanide ISA 51

Author: Wu, Yimin, primary, Ellis, Ruth D., additional, Shaffer, Donna, additional, Fontes, Erica, additional, Malkin, Elissa M., additional, Mahanty, Siddhartha, additional, Fay, Michael P., additional, Narum, David, additional, Rausch, Kelly, additional, Miles, Aaron P., additional, Aebig, Joan, additional, Orcutt, Andrew, additional, Muratova, Olga, additional, Song, Guanhong, additional, Lambert, Lynn, additional, Zhu, Daming, additional, Miura, Kazutoyo, additional, Long, Carole, additional, Saul, Allan, additional, Miller, Louis H., additional, and Durbin, Anna P., additional
Published: 2008
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33. Ex Vivo Cytokine and Memory T Cell Responses to the 42-kDa Fragment of Plasmodium falciparum Merozoite Surface Protein-1 in Vaccinated Volunteers

Author: Huaman, Maria Cecilia, primary, Martin, Laura B., additional, Malkin, Elissa, additional, Narum, David L., additional, Miller, Louis H., additional, Mahanty, Siddhartha, additional, and Long, Carole A., additional
Published: 2008
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34. Impact of a Plasmodium falciparum AMA1 Vaccine on Antibody Responses in Adult Malians

Author: Dicko, Alassane, primary, Diemert, David J., additional, Sagara, Issaka, additional, Sogoba, Moussa, additional, Niambele, Mohamed B., additional, Assadou, Mahamadoun H., additional, Guindo, Ousmane, additional, Kamate, Beh, additional, Baby, Mounirou, additional, Sissoko, Mady, additional, Malkin, Elissa M., additional, Fay, Michael P., additional, Thera, Mahamadou A., additional, Miura, Kazutoyo, additional, Dolo, Amagana, additional, Diallo, Dapa A., additional, Mullen, Gregory E., additional, Long, Carole A., additional, Saul, Allan, additional, Doumbo, Ogobara, additional, and Miller, Louis H., additional
Published: 2007
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35. Phase 1 Study of Two Merozoite Surface Protein 1 (MSP142) Vaccines for Plasmodium falciparum Malaria

Author: Malkin, Elissa, primary, Long, Carole A, additional, Stowers, Anthony W, additional, Zou, Lanling, additional, Singh, Sanjay, additional, MacDonald, Nicholas J, additional, Narum, David L, additional, Miles, Aaron P, additional, Orcutt, Andrew C, additional, Muratova, Olga, additional, Moretz, Samuel E, additional, Zhou, Hong, additional, Diouf, Ababacar, additional, Fay, Michael, additional, Tierney, Eveline, additional, Leese, Philip, additional, Mahanty, Siddhartha, additional, Miller, Louis H, additional, Saul, Allan, additional, and Martin, Laura B, additional
Published: 2007
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36. Phase 1 Clinical Trial of Apical Membrane Antigen 1: an Asexual Blood-Stage Vaccine for Plasmodium falciparum Malaria

Author: Malkin, Elissa M., primary, Diemert, David J., additional, McArthur, Julie H., additional, Perreault, John R., additional, Miles, Aaron P., additional, Giersing, Birgitte K., additional, Mullen, Gregory E., additional, Orcutt, Andrew, additional, Muratova, Olga, additional, Awkal, May, additional, Zhou, Hong, additional, Wang, Jin, additional, Stowers, Anthony, additional, Long, Carole A., additional, Mahanty, Siddhartha, additional, Miller, Louis H., additional, Saul, Allan, additional, and Durbin, Anna P., additional
Published: 2005
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37. Molecular Markers for Failure of Sulfadoxine‐Pyrimethamine and Chlorproguanil‐Dapsone Treatment ofPlasmodium falciparumMalaria

Author: Kublin, James G., primary, Dzinjalamala, Fraction K., additional, Kamwendo, Deborah D., additional, Malkin, Elissa M., additional, Cortese, Joseph F., additional, Martino, Lisa M., additional, Mukadam, Rabia A. G., additional, Rogerson, Stephen J., additional, Lescano, Andres G., additional, Molyneux, Malcolm E., additional, Winstanley, Peter A., additional, Chimpeni, Phillips, additional, Taylor, Terrie E., additional, and Plowe, Christopher V., additional
Published: 2002
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38. A Phase 1 Trial of MSP2-C1, a Blood-Stage Malaria Vaccine Containing 2 Isoforms of MSP2 Formulated with Montanide® ISA 720.

Author: McCarthy, James S., Marjason, Joanne, Elliott, Suzanne, Fahey, Paul, Bang, Gilles, Malkin, Elissa, Tierney, Eveline, Aked-Hurditch, Hayley, Adda, Christopher, Cross, Nadia, Richards, Jack S., Fowkes, Freya J. I., Boyle, Michelle J., Long, Carole, Druilhe, Pierre, Beeson, James G., and Anders, Robin F.
Subjects: MALARIA vaccines, MANNITOL, CLINICAL trials, IMMUNOGLOBULIN G, ALTERNATIVE medicine, IMMUNIZATION, DRUG dosage, IMMUNOFLUORESCENCE
Abstract: Background: In a previous Phase 1/2b malaria vaccine trial testing the 3D7 isoform of the malaria vaccine candidate Merozoite surface protein 2 (MSP2), parasite densities in children were reduced by 62%. However, breakthrough parasitemias were disproportionately of the alternate dimorphic form of MSP2, the FC27 genotype. We therefore undertook a dose-escalating, double-blinded, placebo-controlled Phase 1 trial in healthy, malaria-nai&vuml;e adults of MSP2-C1, a vaccine containing recombinant forms of the two families of msp2 alleles, 3D7 and FC27 (EcMSP2-3D7 and EcMSP2-FC27), formulated in equal amounts with Montanide®ISA 720 as a water-in-oil emulsion. Methodology/Principal Findings: The trial was designed to include three dose cohorts (10, 40, and 80 mg), each with twelve subjects receiving the vaccine and three control subjects receiving Montanide®ISA 720 adjuvant emulsion alone, in a schedule of three doses at 12-week intervals. Due to unexpected local reactogenicity and concern regarding vaccine stability, the trial was terminated after the second immunisation of the cohort receiving the 40 µg dose; no subjects received the 80 µg dose. Immunization induced significant IgG responses to both isoforms of MSP2 in the 10 µg and 40 mg dose cohorts, with antibody levels by ELISA higher in the 40 µg cohort. Vaccine-induced antibodies recognised native protein by Western blots of parasite protein extracts and by immunofluorescence microscopy. Although the induced anti- MSP2 antibodies did not directly inhibit parasite growth in vitro, IgG from the majority of individuals tested caused significant antibody-dependent cellular inhibition (ADCI) of parasite growth. Conclusions/Significance: As the majority of subjects vaccinated with MSP2-C1 developed an antibody responses to both forms of MSP2, and that these antibodies mediated ADCI provide further support for MSP2 as a malaria vaccine candidate. However, in view of the reactogenicity of this formulation, further clinical development of MSP2-C1 will require formulation of MSP2 in an alternative adjuvant. [ABSTRACT FROM AUTHOR]
Published: 2011
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39. Phase 1 Trial of Malaria Transmission Blocking Vaccine Candidates Pfs25 and Pvs25 Formulated with Montanide ISA 51.

Author: Yimin Wu, Ellis, Ruth D., Shaffer, Donna, Fontes, Erica, Malkin, Elissa M., Mahanty, Siddhartha, Fay, Michael P., Narum, David, Rausch, Kelly, Miles, Aaron P., Aebig, Joan, Orcutt, Andrew, Muratova, Olga, Song, Guanhong, Lambert, Lynn, Daming Zhu, Miura, Kazutoyo, Long, Carole, Saul, Allan, and Miller, Louis H.
Subjects: MALARIA vaccines, MALARIA transmission, EMULSIONS (Pharmacy), VACCINATION complications, CLINICAL trials, BLOCKING antibodies, ERYTHEMA, TOXICITY testing, DRUG resistance
Abstract: Background: Pfs25 and Pvs25, surface proteins of mosquito stage of the malaria parasites P. falciparum and P. vivax, respectively, are leading candidates for vaccines preventing malaria transmission by mosquitoes. This single blinded, dose escalating, controlled Phase 1 study assessed the safety and immunogenicity of recombinant Pfs25 and Pvs25 formulated with Montanide ISA 51, a water-in-oil emulsion. Methodology/Principal Findings: The trial was conducted at The Johns Hopkins Center for Immunization Research, Washington DC, USA, between May 16, 2005-April 30, 2007. The trial was designed to enroll 72 healthy male and nonpregnant female volunteers into 1 group to receive adjuvant control and 6 groups to receive escalating doses of the vaccines. Due to unexpected reactogenicity, the vaccination was halted and only 36 volunteers were enrolled into 4 groups: 3 groups of 10 volunteers each were immunized with 5 mg of Pfs25/ISA 51, 5 μg of Pvs25/ISA 51, or 20 μg of Pvs25/ISA 51, respectively. A fourth group of 6 volunteers received adjuvant control (PBS/ISA 51). Frequent local reactogenicity was observed. Systemic adverse events included two cases of erythema nodosum considered to be probably related to the combination of the antigen and the adjuvant. Significant antibody responses were detected in volunteers who completed the lowest scheduled doses of Pfs25/ISA 51. Serum anti-Pfs25 levels correlated with transmission blocking activity. Conclusion/Significance: It is feasible to induce transmission blocking immunity in humans using the Pfs25/ISA 51 vaccine, but these vaccines are unexpectedly reactogenic for further development. This is the first report that the formulation is associated with systemic adverse events including erythema nodosum. [ABSTRACT FROM AUTHOR]
Published: 2008
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40. Phase 1 Study of Two Merozoite Surface Protein 1 (MSP142) Vaccines for Plasmodium falciparum Malaria.

Author: Malkin, Elissa, Long, Carole A., Stowers, Anthony W., Zou, Lanling, Singh, Sanjay, MacDonald, Nicholas J., Narum, David L., Miles, Aaron P., Orcutt, Andrew C., Muratova, Olga, Moretz, Samuel E., Hong Zhou, Diouf, Ababacar, Fay, Michael, Tierney, Eveline, Leese, Philip, Mahanty, Siddhartha, Miller, Louis H., Saul, Allan, and Martin, Laura B.
Subjects: *CLINICAL drug trials, *PARASITIC vaccines, *PLASMODIUM falciparum, *MALARIA, *PROTEINS, *IMMUNOGLOBULINS
Abstract: Objectives: To assess the safety and immunogenicity of two vaccines, MSP142-FVO/ Alhydrogel and MSP142-3D7/Alhydrogel, targeting blood-stage Plasmodium falciparum parasites. Design: A Phase 1 open-label, dose-escalating study. Setting: Quintiles Phase 1 Services, Lenexa, Kansas between July 2004 and November 2005. Participants: Sixty healthy malaria-naïve volunteers 18-48 y of age. Interventions: The C-terminal 42-kDa region of merozoite surface protein 1 (MSP142) corresponding to the two allelic forms present in FVO and 3D7 P. falciparum lines were expressed in Escherichia coli, refolded, purified, and formulated on Alhydrogel (aluminum hydroxide). For each vaccine, volunteers in each of three dose cohorts (5, 20, and 80 µg) were vaccinated at 0, 28, and 180 d. Volunteers were followed for 1 y. Outcome Measures: The safety of MSP142-FVO/Alhydrogel and MSP142-3D7/Alhydrogel was assessed. The antibody response to each vaccine was measured by reactivity to homologous and heterologous MSP142, MSP119, and MSP133 recombinant proteins and recognition of FVO and 3D7 parasites. Results: Anti-MSP142 antibodies were detected by ELISA in 20/27 (74%) and 22/27 (81%) volunteers receiving three vaccinations of MSP142-FVO/Alhydrogel or MSP142-3D7/Alhydrogel, respectively. Regardless of the vaccine, the antibodies were cross-reactive to both MSP142-FVO and MSP142-3D7 proteins. The majority of the antibody response targeted the C-terminal 19-kDa domain of MSP142, although low-level antibodies to the N-terminal 33-kDa domain of MSP142 were also detected. Immunofluorescence microscopy of sera from the volunteers demonstrated reactivity with both FVO and 3D7 P. falciparum schizonts and free merozoites. Minimal in vitro growth inhibition of FVO or 3D7 parasites by purified IgG from the sera of the vaccinees was observed. Conclusions: The MSP142/Alhydrogel vaccines were safe and well tolerated but not sufficiently immunogenic to generate a biologic effect in vitro. Addition of immunostimulants to the Alhydrogel formulation to elicit higher vaccine-induced responses in humans may be required for an effective vaccine. [ABSTRACT FROM AUTHOR]
Published: 2007

41. Bivalent and Monovalent SARS-CoV-2 Variant Vaccine Boosters Improve coverage of the known Antigenic Landscape: Results of the COVID-19 Variant Immunologic Landscape (COVAIL) Trial.

Author: Branche A, Rouphael N, Diemert D, Falsey A, Losada C, Baden LR, Frey S, Whitaker J, Little S, Anderson E, Walter E, Novak R, Rupp R, Jackson L, Babu T, Kottkamp A, Luetkemeyer A, Immergluck L, Presti R, Backer M, Winokur P, Mahgoub S, Goepfert P, Fusco D, Malkin E, Bethony J, Walsh E, Graciaa D, Samaha H, Sherman A, Walsh S, Abate G, Oikonomopoulou Z, El Sahly H, Martin T, Kamidani S, Smith M, Ladner B, Porterfield L, Dunstan M, Wald A, Davis T, Atmar R, Mulligan M, Lyke K, Posavad C, Meagher M, Stephens D, Neuzil K, Abebe K, Hill H, Albert J, Telu K, Mu J, Lewis T, Giebeig L, Eaton A, Netzl A, Wilks S, Tureli S, Makhene M, Crandon S, Montefiori D, Makowski M, Smith D, Nayak S, Roberts P, and Beigel J
Abstract: Vaccine protection against COVID-19 wanes over time and has been impacted by the emergence of new variants with increasing escape of neutralization. The COVID-19 Variant Immunologic Landscape (COVAIL) randomized clinical trial (clinicaltrials.gov NCT05289037) compares the breadth, magnitude and durability of antibody responses induced by a second COVID-19 vaccine boost with mRNA (Moderna mRNA-1273 and Pfizer-BioNTech BNT162b2), or adjuvanted recombinant protein (Sanofi CoV2 preS DTM-AS03) monovalent or bivalent vaccine candidates targeting ancestral and variant SARS-CoV-2 spike antigens (Beta, Delta and Omicron BA.1). We found that boosting with a variant strain is not associated with loss in neutralization against the ancestral strain. However, while variant vaccines compared to the prototype/wildtype vaccines demonstrated higher neutralizing activity against Omicron BA.1 and BA.4/5 subvariants for up to 3 months after vaccination, neutralizing activity was lower for more recent Omicron subvariants. Our study, incorporating both antigenic distances and serologic landscapes, can provide a framework for objectively guiding decisions for future vaccine updates.
Published: 2023
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42. SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses.

Author: Branche AR, Rouphael NG, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Anderson EJ, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Malkin E, Bethony JM, Walsh EE, Graciaa DS, Samaha H, Sherman AC, Walsh SR, Abate G, Oikonomopoulou Z, El Sahly HM, Martin TCS, Rostad CA, Smith MJ, Ladner BG, Porterfield L, Dunstan M, Wald A, Davis T, Atmar RL, Mulligan MJ, Lyke KE, Posavad CM, Meagher MA, Stephens DS, Neuzil KM, Abebe K, Hill H, Albert J, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Türeli S, Makhene M, Crandon S, Lee M, Nayak SU, Montefiori DC, Makowski M, Smith DJ, Roberts PC, and Beigel JH
Abstract: Background: Protection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines., Methods: This phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a SARS-CoV-2 primary series and a single boost. Eligible participants were randomized to one of six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), Omicron BA.1+Beta (1 or 2 doses), Omicron BA.1+Delta, Omicron BA.1 monovalent, and Omicron BA.1+Prototype. Neutralization antibody titers (ID 50 ) were assessed for D614G, Delta, Beta and Omicron BA.1 variants and Omicron BA.2.12.1 and BA.4/BA.5 subvariants 15 days after vaccination., Results: From March 30 to May 6, 2022, 597 participants were randomized and vaccinated. Median age was 53 years, and 20% had a prior SARS-CoV-2 infection. All vaccines were safe and well-tolerated. Day 15 geometric mean titers (GMT) against D614G were similar across arms and ages, and higher with prior infection. For uninfected participants, Day 15 Omicron BA.1 GMTs were similar across Omicron-containing vaccine arms (3724-4561) and higher than Prototype (1,997 [95%CI:1,482-2,692]). The Omicron BA.1 monovalent and Omicron BA.1+Prototype vaccines induced a geometric mean ratio (GMR) to Prototype for Omicron BA.1 of 2.03 (97.5%CI:1.37-3.00) and 1.56 (97.5%CI:1.06-2.31), respectively. A subset of samples from uninfected participants in four arms were also tested in a different laboratory at Day 15 for neutralizing antibody titers to D614G and Omicron subvariants BA.1, BA.2.12.2 and BA.4/BA.5. Omicron BA.4/BA.5 GMTs were approximately one third BA.1 GMTs (Prototype 517 [95%CI:324-826] vs. 1503 [95%CI:949-2381]; Omicron BA.1+Beta 628 [95%CI:367-1,074] vs. 2125 [95%CI:1139-3965]; Omicron BA.1+Delta 765 [95%CI:443-1,322] vs. 2242 [95%CI:1218-4128] and Omicron BA.1+Prototype 635 [95%CI:447-903] vs. 1972 [95%CI:1337-2907)., Conclusions: Higher Omicron BA.1 titers were observed with Omicron-containing vaccines compared to Prototype vaccine and titers against Omicron BA.4/BA.5 were lower than against BA.1 for all candidate vaccines., Clinicaltrialsgov: NCT05289037.
Published: 2022
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43. Recombinant Liver Stage Antigen-1 (LSA-1) formulated with AS01 or AS02 is safe, elicits high titer antibody and induces IFN-gamma/IL-2 CD4+ T cells but does not protect against experimental Plasmodium falciparum infection.

Author: Cummings JF, Spring MD, Schwenk RJ, Ockenhouse CF, Kester KE, Polhemus ME, Walsh DS, Yoon IK, Prosperi C, Juompan LY, Lanar DE, Krzych U, Hall BT, Ware LA, Stewart VA, Williams J, Dowler M, Nielsen RK, Hillier CJ, Giersing BK, Dubovsky F, Malkin E, Tucker K, Dubois MC, Cohen JD, Ballou WR, and Heppner DG Jr
Subjects: Adjuvants, Immunologic pharmacology, Adult, Antibodies, Protozoan blood, Antibody Formation, Female, Humans, Immunity, Cellular, Immunity, Humoral, Immunization Schedule, Immunization, Secondary, Interferon-gamma immunology, Interleukin-2 immunology, Malaria Vaccines administration & dosage, Malaria Vaccines adverse effects, Malaria, Falciparum immunology, Male, Parasitemia immunology, Plasmodium falciparum immunology, Recombinant Proteins immunology, Sporozoites immunology, Young Adult, Antigens, Protozoan immunology, CD4-Positive T-Lymphocytes immunology, Malaria Vaccines immunology, Malaria, Falciparum prevention & control
Abstract: Plasmodium falciparum Liver Stage Antigen 1 (LSA-1) is a pre-erythrocytic stage antigen. Our LSA-1 vaccine candidate is a recombinant protein with full-length C- and N-terminal flanking domains and two of the 17 amino acid repeats from the central repeat region termed "LSA-NRC." We describe the first Phase I/II study of this recombinant LSA-NRC protein formulated with either the AS01 or AS02 adjuvant system. We conducted an open-label Phase I/II study. Thirty-six healthy malaria-naïve adults received one of four formulations by intra-deltoid injection on a 0 and 1 month schedule; low dose (LD) LSA-NRC/AS01:10microg LSA-NRC/0.5ml AS01 (n=5), high dose (HD) LSA-NRC/AS01: 50microg LSA-NRC/0.5ml AS01 (n=13); LD LSA-NRC/AS02: 10microg LSA-NRC/0.5ml AS02 (n=5) and HD LSA-NRC/AS02: 50microg LSA-NRC/0.5ml AS02 (n=13). Two weeks post-second immunization, the high dose vaccinees and 6 non-immunized infectivity controls underwent experimental malaria sporozoite challenge. The vaccines showed a reassuring safety profile but were moderately reactogenic. There were no serious adverse events. All subjects seroconverted after the first immunization. Following the second immunization, LSA-1-specific CD4+ T cells producing two cytokines (IL-2 and IFN-gamma) were found by intra-cellular staining in all subjects in the LD LSA-NRC/AS01B group and in 3 of 5 subjects in the LD LSA-NRC/AS02 group. In contrast, the HD LSA-NRC/AS01 and HD LSA-NRC/AS02 group subjects had fewer LSA-1-specific CD4+ T cells, and minimal to no IFN-gamma responses. There was no increase in LSA-1-specific CD8+ T cells found in any group. Per protocol, 22 high dose vaccinees, but no low dose vaccinees, underwent P. falciparum homologous malaria challenge (3D7 clone). All vaccinees became parasitemic and there was no delay in their pre-patent period versus controls (p=0.95). LSA-NRC/AS01 and LSA-NRC/AS02 elicited antigen-specific antibody and CD4+ T cell responses, but elicited no protective immunity. Although the optimal antigen dose of LSA-NRC may not have been selected for the challenge portion of the protocol, further vaccine development based upon LSA-1 should not be excluded and should include alternative vaccine platforms able to elicit additional effector mechanisms such as CD8+ T cells., (Copyright 2009. Published by Elsevier Ltd.)
Published: 2010
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44. Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya.

Author: Ogutu BR, Apollo OJ, McKinney D, Okoth W, Siangla J, Dubovsky F, Tucker K, Waitumbi JN, Diggs C, Wittes J, Malkin E, Leach A, Soisson LA, Milman JB, Otieno L, Holland CA, Polhemus M, Remich SA, Ockenhouse CF, Cohen J, Ballou WR, Martin SK, Angov E, Stewart VA, Lyon JA, Heppner DG, and Withers MR
Subjects: Animals, Child, Child, Preschool, Double-Blind Method, Humans, Infant, Kenya, Malaria, Falciparum prevention & control, Merozoite Surface Protein 1 immunology, Plasmodium falciparum immunology, Rabies Vaccines, Treatment Failure, Treatment Outcome, Antigen-Antibody Complex blood, Malaria Vaccines administration & dosage, Merozoite Surface Protein 1 therapeutic use
Abstract: Objective: The antigen, falciparum malaria protein 1 (FMP1), represents the 42-kDa C-terminal fragment of merozoite surface protein-1 (MSP-1) of the 3D7 clone of P. falciparum. Formulated with AS02 (a proprietary Adjuvant System), it constitutes the FMP1/AS02 candidate malaria vaccine. We evaluated this vaccine's safety, immunogenicity, and efficacy in African children., Methods: A randomised, double-blind, Phase IIb, comparator-controlled trial.The trial was conducted in 13 field stations of one mile radii within Kombewa Division, Nyanza Province, Western Kenya, an area of holoendemic transmission of P. falciparum. We enrolled 400 children aged 12-47 months in general good health.Children were randomised in a 1ratio1 fashion to receive either FMP1/AS02 (50 microg) or Rabipur(R) rabies vaccine. Vaccinations were administered on a 0, 1, and 2 month schedule. The primary study endpoint was time to first clinical episode of P. falciparum malaria (temperature >/=37.5 degrees C with asexual parasitaemia of >/=50,000 parasites/microL of blood) occurring between 14 days and six months after a third dose. Case detection was both active and passive. Safety and immunogenicity were evaluated for eight months after first immunisations; vaccine efficacy (VE) was measured over a six-month period following third vaccinations., Results: 374 of 400 children received all three doses and completed six months of follow-up. FMP1/AS02 had a good safety profile and was well-tolerated but more reactogenic than the comparator. Geometric mean anti-MSP-1(42) antibody concentrations increased from1.3 microg/mL to 27.3 microg/mL in the FMP1/AS02 recipients, but were unchanged in controls. 97 children in the FMP1/AS02 group and 98 controls had a primary endpoint episode. Overall VE was 5.1% (95% CI: -26% to +28%; p-value = 0.7)., Conclusions: FMP1/AS02 is not a promising candidate for further development as a monovalent malaria vaccine. Future MSP-1(42) vaccine development should focus on other formulations and antigen constructs., Trial Registration: Clinicaltrials.gov NCT00223990.
Published: 2009
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