326 results on '"Kublin, James G"'
Search Results
2. Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial
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Zhang, Bo, Fong, Youyi, Fintzi, Jonathan, Chu, Eric, Janes, Holly E., Kenny, Avi, Carone, Marco, Benkeser, David, van der Laan, Lars W. P., Deng, Weiping, Zhou, Honghong, Wang, Xiaowei, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, Chen, Haiyan, Reeder, Isabel, Carpp, Lindsay N., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Huynh, Chuong, Fichtenbaum, Carl J., Kalams, Spyros, Gay, Cynthia L., Andrasik, Michele P., Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Priddy, Frances, Das, Rituparna, Girard, Bethany, El Sahly, Hana M., Baden, Lindsey R., Jones, Thomas, Donis, Ruben O., Koup, Richard A., Gilbert, Peter B., and Follmann, Dean
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- 2024
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3. Adolescent BCG revaccination induces a phenotypic shift in CD4+ T cell responses to Mycobacterium tuberculosis
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Dintwe, One B., Ballweber Fleming, Lamar, Voillet, Valentin, McNevin, John, Seese, Aaron, Naidoo, Anneta, Omarjee, Saleha, Bekker, Linda-Gail, Kublin, James G., De Rosa, Stephen C., Newell, Evan W., Fiore-Gartland, Andrew, Andersen-Nissen, Erica, and McElrath, M. Juliana
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- 2024
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4. Statistical design and analysis of controlled human malaria infection trials
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Tian, Xiaowen, Janes, Holly E., and Kublin, James G.
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- 2024
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5. Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial
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Allagappen, Jon, Andriesen, Jessica, Ayres, Alison, Bekker, Linda-Gail, Borremans, Caroline, Brumskine, William, Chilengi, Roma, Dubula, Thozama, Garrett, Nigel, Gelderblom, Huub, Gill, Katherine, Hoosain, Zaheer, Hosseinipour, Mina, Hutter, Julia, Inambao, Mubiana, Innes, Craig, Kilembe, William, Kotze, Philippus, Kotze, Sheena, Laher, Fatima, Laszlo, Imre, Lazarus, Erica, Malahleha, Mookho, Mathebula, Matsontso, Matoga, Mitch, McClennen, Rachael, Mda, Pamela, Meerts, Peter, Naicker, Vimla, Naidoo, Logashvari, Philip, Tricia, Pitsi, Annah, Scheppler, Lorenz, Sopher, Carrie, Takuva, Simbarashe G., Viegas, Edna, Weijtens, Mo, Yuan, Olive, Gray, Glenda E, Mngadi, Kathryn, Lavreys, Ludo, Nijs, Steven, Gilbert, Peter B, Hural, John, Hyrien, Ollivier, Juraska, Michal, Luedtke, Alex, Mann, Philipp, McElrath, M Juliana, Odhiambo, Jackline A, Stieh, Daniel J, van Duijn, Janine, Takalani, Azwidihwi N, Willems, Wouter, Tapley, Asa, Tomaras, Georgia D, Van Hoof, Johan, Schuitemaker, Hanneke, Swann, Edith, Barouch, Dan H, Kublin, James G, Corey, Lawrence, Pau, Maria G, Buchbinder, Susan, and Tomaka, Frank
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- 2024
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6. Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control study
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Allagappen, Jon, Andriesen, Jessica, Ayres, Alison, Baral, Saman, Bekker, Linda-Gail, Besethi, Asiphe, Borremans, Caroline, Braams, Esmee, Brackett, Caroline, Brumskine, William, Chilengi, Roma, Choi, Rachel, Dubula, Thozama, Dumas, Jaiden Seongmi, Dunn, Brooke, Etikala, Radhika, Euler, Zelda, Everett, Sarah, Garrett, Nigel, Gelderblom, Huub, Gill, Katherine, Gillespie, Kevin, Goedhart, Dimitri, Goosmann, Erik, Grant, Shannon, Hands, Ellie, Haynes, Barton, Herringer, Bronwill, Hoosain, Zaheer, Hosseinipour, Mina, Hunidzarira, Portia, Hutter, Julia, Inambao, Mubiana, Innes, Craig, Keyes, Taylor, Kilembe, William, Kotze, Philippus, Kotze, Sheena, Laher, Fatima, Laszlo, Imre, Lazarus, Erica, Liao, Hua-Xin, Lin, Yong, Lu, Helen, Lucas, Judith, Malahleha, Mookho, McNair, Tara, Meerts, Peter, Mgaga, Zinhle, Montlha, Mahlodi, Mosito, Boitumelo, Moultrie, Andrew, Mudrak, Sarah, Oriol-Mathieu, Valérie, Sarzotti-Kelsoe, Marcella, Mathebula, Matson Tso, Matoga, Mitch, McClennen, Rachael, Mda, Pamela, Naicker, Vimla, Naidoo, Logashvari, Okkers, Cindy-Ann, Omarjee, Saleha, Pasmans, Hella, Philip, Tricia, Pinter, Abraham, Pitsi, Annah, Ramos, Ornelia, Randhawa, April, Roels, Sanne, Rohith, Shamiska, Rutten, Lucy, Sadoff, Jerald, Salinas, Gabriela, Salzgeber, Yvonne, Scheppler, Lorenz, Schwedhelm, Katharine, Schuller, Nicolette, Sharak, Angelina, Stanfield-Oakley, Sherry, Sopher, Carrie, Tafatatha, Terence, Takuva, Simbarashe G., Tang, Chan, Vandebosch, An, Viegas, Edna, Voillet, Valentin, Wegmann, Frank, Weijtens, Mo, Wilcox, Stephany, Williams, Anthony, Yu, Chenchen, Yu, Pei-Chun, Yuan, Olive, Zhang, Xuehan, Kenny, Avi, van Duijn, Janine, Dintwe, One, Heptinstall, Jack, Burnham, Randy, Sawant, Sheetal, Zhang, Lu, Mielke, Dieter, Khuzwayo, Sharon, Omar, Faatima Laher, Goodman, Derrick, Fong, Youyi, Benkeser, David, Zou, Rodger, Hural, John, Hyrien, Ollivier, Juraska, Michal, Luedtke, Alex, van der Laan, Lars, Giorgi, Elena E., Magaret, Craig, Carpp, Lindsay N., Pattacini, Laura, van de Kerkhof, Tom, Korber, Bette, Willems, Wouter, Fisher, Leigh H., Schuitemaker, Hanneke, Swann, Edith, Kublin, James G., Pau, Maria G., Buchbinder, Susan, Tomaka, Frank, Nijs, Steven, Lavreys, Ludo, Gelderblom, Huub C., Corey, Lawrence, Mngadi, Kathryn, Gray, Glenda E., Borducchi, Erica, Hendriks, Jenny, Seaton, Kelly E., Zolla-Pazner, Susan, Barouch, Dan H., Ferrari, Guido, De Rosa, Stephen C., McElrath, M Juliana, Andersen-Nissen, Erica, Stieh, Daniel J., Tomaras, Georgia D., and Gilbert, Peter B.
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- 2024
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7. Safety and immunogenicity of a polyvalent DNA–protein HIV vaccine with matched Env immunogens delivered as a prime–boost regimen or coadministered in HIV-uninfected adults in the USA (HVTN 124): a phase 1, placebo-controlled, double-blind randomised controlled trial
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Frank, Ian, Li, Shuying S, Grunenberg, Nicole, Overton, Edgar T, Robinson, Samuel T, Zheng, Hua, Seaton, Kelly E, Heptinstall, Jack R, Allen, Mary A, Mayer, Kenneth H, Culver, Daniel A, Keefer, Michael C, Edupuganti, Sri, Pensiero, Michael N, Mehra, Vijay L, De Rosa, Stephen C, Morris, Daryl E, Wang, Shixia, Seaman, Michael S, Montefiori, David C, Ferrari, Guido, Tomaras, Georgia D, Kublin, James G, Corey, Lawrence, and Lu, Shan
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- 2024
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8. Polytopic fractional delivery of an HIV vaccine alters cellular responses and results in increased epitope breadth in a phase 1 randomized trial
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Kalichman, Artur, Edlefsen, Paul, Enama, Mary, Hural, John, Holt, Renee, Dunbar, Debora, Crawford, Dave, Maki, Ian, Johannessen, Jan, Estep, Scharla, Grigoriev, Yevgeny, Madenwald, Tamra, Hansen, Marianne, Holman, Drienna, Fair, Ramey, Meyer, Genevieve, Luke-Kilolam, Anya, Miner, Maurine D., deCamp, Allan, Grunenberg, Nicole, De Rosa, Stephen C., Fiore-Gartland, Andrew, Bar, Katherine, Spearman, Paul, Allen, Mary, Yu, Pei-Chun, Manso, Bryce, Frahm, Nicole, Kalams, Spyros, Baden, Lindsey, Keefer, Michael C., Scott, Hyman M., Novak, Richard, Van Tieu, Hong, Tomaras, Georgia D., Kublin, James G., McElrath, M. Juliana, Corey, Lawrence, and Frank, Ian
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- 2024
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9. Molecular detection of pre-ribosomal RNAs of Mycobacterium bovis bacille Calmette-Guérin and Mycobacterium tuberculosis to enhance pre-clinical tuberculosis drug and vaccine development
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Chang, Ming, Venkatasubramanian, Sambasivan, Barrett, Holly, Urdahl, Kevin B., Weigel, Kris M., Cangelosi, Gerard A., Shah, Javeed A., Saha, Aparajita, Feng, Libing, Adams, Kristin N., Sherman, David R., Smith, Nahum, Seshadri, Chetan, Kublin, James G., and Murphy, Sean C.
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- 2024
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10. Oral tolerance to systemic vaccination remains intact without RORγt expression in regulatory T cells
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Potchen, Nicole B., Johnson, Andrew M.F., Hager, Kevin, Graham, Jessica, Van, Phuong, Lyn-Kew, Katelyn H., Warrier, Lakshmi, Talavera, Irene Cruz, Lund, Jennifer M., and Kublin, James G.
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- 2023
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11. Risk of COVID-19 after natural infection or vaccination
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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.
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- 2023
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12. Publisher Correction: Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
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Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
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- 2023
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13. Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
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Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
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- 2023
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14. Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine
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Benkeser, David, Fong, Youyi, Janes, Holly E., Kelly, Elizabeth J., Hirsch, Ian, Sproule, Stephanie, Stanley, Ann Marie, Maaske, Jill, Villafana, Tonya, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Ayala, Victor, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Carpp, Lindsay N., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Isaacs, Margaret Brewinski, Makhene, Mamodikoe, Tong, Tina, Robb, Merlin L., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Hoffman, Corey, Falsey, Ann R., Sobieszczyk, Magdalena, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
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- 2023
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15. Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial
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Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B., Omar, Faatima Laher, Kee, Jia J., Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M., Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D., Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E., De Rosa, Stephen, Diazgranados, Carlos A., Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W., Kanesa-thasan, Niranjan, Kublin, James G., Tomaras, Georgia D., McElrath, M. Juliana, Corey, Lawrence, Mngadi, Kathryn, and Goepfert, Paul
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Testing ,Prevention ,AIDS vaccines -- Testing ,HIV infections -- Prevention ,Immunologic adjuvants -- Testing ,Immunological adjuvants -- Testing ,HIV infection -- Prevention - Abstract
Author(s): Zoe Moodie 1,*, Erica Andersen-Nissen 1,2, Nicole Grunenberg 1, One B. Dintwe 1,2, Faatima Laher Omar 2, Jia J. Kee 1, Linda-Gail Bekker 3, Fatima Laher 4, Nivashnee Naicker [...], Background Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen modified for the Southern African region. The RV144 trial of a recombinant canarypox vaccine vector expressing HIV env subtype B (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost adjuvanted with alum is the only trial to have shown modest HIV vaccine efficacy. Data generated after RV144 suggested that use of MF59 adjuvant might allow lower protein doses to be used while maintaining robust immune responses. We evaluated safety and immunogenicity of an HIV recombinant canarypox vaccine vector expressing HIV env subtype C (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost (gp120) adjuvanted with alum (ALVAC-HIV+gp120/alum) or MF59 (ALVAC-HIV+gp120/MF59) or unadjuvanted (ALVAC-HIV+gp120/no-adjuvant) and a regimen where ALVAC-HIV+gp120 adjuvanted with MF59 was used for the prime and boost (ALVAC-HIV+gp120/MF59 coadministration). Methods and findings Between June 19, 2017 and June 14, 2018, 132 healthy adults without HIV in South Africa, Zimbabwe, and Mozambique were randomized to receive intramuscularly: (1) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/MF59 (months 3, 6, and 12), n = 36; (2) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/alum (months 3, 6, and 12), n = 36; (3) 4 doses of ALVAC-HIV+gp120/MF59 coadministered (months 0, 1, 6, and 12), n = 36; or (4) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/no adjuvant (months 3, 6, and 12), n = 24. Primary outcomes were safety and occurrence and mean fluorescence intensity (MFI) of vaccine-induced gp120-specific IgG and IgA binding antibodies at month 6.5. All vaccinations were safe and well-tolerated; increased alanine aminotransferase was the most frequent related adverse event, occurring in 2 (1.5%) participants (1 severe, 1 mild). At month 6.5, vaccine-specific gp120 IgG binding antibodies were detected in 100% of vaccinees for all 4 vaccine groups. No significant differences were seen in the occurrence and net MFI of vaccine-specific IgA responses between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/alum-prime-boost groups or between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/MF59 coadministration groups. Limitations were the relatively small sample size per group and lack of evaluation of higher gp120 doses. Conclusions Although MF59 was expected to enhance immune responses, alum induced similar responses to MF59, suggesting that the choice between these adjuvants may not be critical for the ALVAC+gp120 regimen. Trial registration HVTN 107 was registered with the South African National Clinical Trials Registry (DOH-27-0715-4894) and ClinicalTrials.gov (NCT03284710).
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- 2024
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16. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
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Fong, Youyi, McDermott, Adrian B., Benkeser, David, Roels, Sanne, Stieh, Daniel J., Vandebosch, An, Le Gars, Mathieu, Van Roey, Griet A., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Amoa-Awua, Obrimpong, Basappa, Manjula, Flach, Britta, Lin, Bob C., Moore, Christopher, Naisan, Mursal, Naqvi, Muhammed, Narpala, Sandeep, O’Connell, Sarah, Mueller, Allen, Serebryannyy, Leo, Castro, Mike, Wang, Jennifer, Petropoulos, Christos J., Luedtke, Alex, Hyrien, Ollivier, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Kenny, Avi, Carone, Marco, Wolfe, Daniel N., Sadoff, Jerald, Gray, Glenda E., Grinsztejn, Beatriz, Goepfert, Paul A., Little, Susan J., Paiva de Sousa, Leonardo, Maboa, Rebone, Randhawa, April K., Andrasik, Michele P., Hendriks, Jenny, Truyers, Carla, Struyf, Frank, Schuitemaker, Hanneke, Douoguih, Macaya, Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Carpp, Lindsay N., Follmann, Dean, Gilbert, Peter B., Koup, Richard A., and Donis, Ruben O.
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- 2022
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17. Is an HIV vaccine still achievable?
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Kublin, James G.
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- 2023
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18. Targeting enhanced neutralizing antibody responses via increased germinal center activity: early-phase vaccine trials with novel clinical designs
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Hahn, William O., Hill, Joshua A., and Kublin, James G.
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- 2023
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19. Developing tuberculosis vaccines for people with HIV: consensus statements from an international expert panel
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Miner, Maurine D, Hatherill, Mark, Mave, Vidya, Gray, Glenda E, Nachman, Sharon, Read, Sarah W, White, Richard G, Hesseling, Anneke, Cobelens, Frank, Patel, Sheral, Frick, Mike, Bailey, Theodore, Seder, Robert, Flynn, Joanne, Rengarajan, Jyothi, Kaushal, Deepak, Hanekom, Willem, Schmidt, Alexander C, Scriba, Thomas J, Nemes, Elisa, Andersen-Nissen, Erica, Landay, Alan, Dorman, Susan E, Aldrovandi, Grace, Cranmer, Lisa M, Day, Cheryl L, Garcia-Basteiro, Alberto L, Fiore-Gartland, Andrew, Mogg, Robin, Kublin, James G, Gupta, Amita, and Churchyard, Gavin
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- 2022
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20. Association Between SARS-CoV-2 Viral Load and COVID-19 Vaccination in 4 Phase 3 Trials.
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Janes, Holly, Fisher, Leigh H, Kee, Jia Jin, Parameswaran, Lalitha, Goepfert, Paul A, Falsey, Ann R, Ludwig, James, Magaret, Craig A, Gilbert, Peter B, Kublin, James G, Rouphael, Nadine, Sobieszczyk, Magdalena E, Sahly, Hana M El, Baden, Lindsey R, Grinsztejn, Beatriz, Walsh, Stephen R, Gray, Glenda E, Kotloff, Karen L, Gay, Cynthia L, and Greninger, Alexander L
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SARS-CoV-2 ,COVID-19 ,CLINICAL trial registries ,CLINICAL trials ,COVID-19 vaccines - Abstract
Coronavirus disease 2019 (COVID-19) vaccines reduce severe disease and mortality and may lessen transmission, measured by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL). Evaluating vaccine associations in VL at COVID-19 diagnosis in 4 phase 3 randomized, placebo-controlled vaccine trials, July 2020 to July 2021, VL reductions were 2.78 log
10 copies/mL (95% confidence interval [CI], 1.38–4.18; n = 60 placebo, 11 vaccine) and 2.12 log10 copies/mL (95% CI, 1.44–2.80; n = 594 placebo, 36 vaccine) for NVX-CoV2373 and mRNA-1273, respectively. Associations were not significant for AZD1222 (0.59 log10 copies/mL; 95% CI, −.19 to 1.36; n = 90 placebo, 78 vaccine) or Ad26.COV2.S (0.23 log10 copies/mL; 95% CI, −.01 to.47; n = 916 placebo, 424 vaccine). Thus, vaccines potentially decreased transmission when ancestral SARS-CoV-2 predominated. Clinical Trials Registration. NCT04470427, NCT04505722, NCT04516746, NCT04611802. [ABSTRACT FROM AUTHOR]- Published
- 2024
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21. Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study
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Ake, Julie A., Buchbinder, Susan, Buleza, Karen, Cohen, Kristen W., Crowell, Trevor A., Euler, Zelda, Frank, Ian, Goedhart, Dimitri, Keefer, Michael, Kelly, Colleen, Mayer, Ken, Nkolola, Joseph, Peter, Lauren, Robb, Merlin L., Rouphael, Nadine, Scheppler, Lorenz, Sobieszczyk, Magda, Van Tieu, Hong, Baden, Lindsey R, Stieh, Daniel J, Sarnecki, Michal, Walsh, Stephen R, Tomaras, Georgia D, Kublin, James G, McElrath, M Juliana, Alter, Galit, Ferrari, Guido, Montefiori, David, Mann, Philipp, Nijs, Steven, Callewaert, Katleen, Goepfert, Paul, Edupuganti, Srilatha, Karita, Etienne, Langedijk, Johannes P, Wegmann, Frank, Corey, Lawrence, Pau, Maria G, Barouch, Dan H, Schuitemaker, Hanneke, and Tomaka, Frank
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- 2020
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22. A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis-uninfected adolescents in Cape Town, South Africa
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Bekker, Linda-Gail, Dintwe, One, Fiore-Gartland, Andrew, Middelkoop, Keren, Hutter, Julia, Williams, Anthony, Randhawa, April K., Ruhwald, Morten, Kromann, Ingrid, Andersen, Peter L., DiazGranados, Carlos A., Rutkowski, Kathryn T., Tait, Dereck, Miner, Maurine D., Andersen-Nissen, Erica, De Rosa, Stephen C., Seaton, Kelly E., Tomaras, Georgia D., McElrath, M. Juliana, Ginsberg, Ann, and Kublin, James G.
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- 2020
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23. Safety and immunogenicity of a multivalent HIV vaccine comprising envelope protein with either DNA or NYVAC vectors (HVTN 096): a phase 1b, double-blind, placebo-controlled trial
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Pantaleo, Giuseppe, Janes, Holly, Karuna, Shelly, Grant, Shannon, Ouedraogo, G Laissa, Allen, Mary, Tomaras, Georgia D, Frahm, Nicole, Montefiori, David C, Ferrari, Guido, Ding, Song, Lee, Carter, Robb, Merlin L, Esteban, Mariano, Wagner, Ralf, Bart, Pierre-Alexandre, Rettby, Nils, McElrath, M Juliana, Gilbert, Peter B, Kublin, James G, and Corey, Lawrence
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- 2019
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24. Exploring Ethical Concerns About Human Challenge Studies : A Qualitative Study of Controlled Human Malaria Infection Study Participants' Motivations and Attitudes
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Kraft, Stephanie A., Duenas, Devan M., Kublin, James G., Shipman, Kelly J., Murphy, Sean C., and Shah, Seema K.
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- 2019
25. Non-HIV Vaccine-Induced Immune Responses as Potential Baseline Immunogenicity Predictors of ALVAC-HIV and AIDSVAX B/E-Induced Immune Responses.
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Huang, Ying, Alam, Shomoita, Andersen-Nissen, Erica, Carpp, Lindsay N., Dintwe, One B., Flach, Britta S., Grunenberg, Nicole, Laher, Fatima, De Rosa, Stephen C., Ferrari, Guido, Innes, Craig, Bekker, Linda-Gail, Kublin, James G., McElrath, M. Juliana, Tomaras, Georgia D., Gray, Glenda E., and Gilbert, Peter B.
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HEPATITIS associated antigen ,AIDS vaccines ,TETANUS vaccines ,HEPATITIS B vaccines ,VACCINE effectiveness ,HEPATITIS B virus - Abstract
Identifying correlations between immune responses elicited via HIV and non-HIV vaccines could aid the search for correlates of HIV protection and increase statistical power in HIV vaccine-efficacy trial designs. An exploratory objective of the HVTN 097 phase 1b trial was to assess whether immune responses [focusing on those supported as correlates of risk (CoR) of HIV acquisition] induced via the RV144 pox-prime HIV vaccine regimen correlated with those induced via tetanus toxoid (TT) and/or hepatitis B virus (HBV) vaccines. We measured TT-specific and HBV-specific IgG-binding antibody responses and TT-specific and HBV-specific CD4+ T-cell responses at multiple time points in HVTN 097 participants, and we assessed their correlations at peak time points with HIV vaccine (ALVAC-HIV and AIDSVAX B/E)-induced responses. Four correlations were significant [false discovery rate-adjusted p-value (FDR) ≤ 0.2]. Three of these four were with IgG-binding antibody responses to TT measured one month after TT receipt, with the strongest and most significant correlation [rho = 0.368 (95% CI: 0.096, 0.588; p = 0.008; FDR = 0.137)] being with IgG-binding antibody responses to MN gp120 gDneg (B protein boost) measured two weeks after the second ALVAC-HIV and AIDSVAX B/E boost. The fourth significant correlation [(rho = 0.361; 95% CI: 0.049, 0.609; p = 0.021; FDR = 0.137)] was between CD4+ T-cell responses to a hepatitis B surface antigen peptide pool, measured 2 weeks after the third HBV vaccination, and IgG-binding antibody responses to gp70BCaseAV1V2 (B V1V2 immune correlate), measured two weeks after the second ALVAC-HIV and AIDSVAX B/E boost. These moderate correlations imply that either vaccine, TT or HBV, could potentially provide a moderately useful immunogenicity predictor for the ALVAC-HIV and AIDSVAX B/E HIV vaccine regimen. [ABSTRACT FROM AUTHOR]
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- 2024
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26. Review of Current Tuberculosis Human Infection Studies for Use in Accelerating Tuberculosis Vaccine Development: A Meeting Report.
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Balasingam, Shobana, Dheda, Keertan, Fortune, Sarah, Gordon, Stephen B, Hoft, Daniel, Kublin, James G, Loynachan, Colleen N, McShane, Helen, Morton, Ben, Nambiar, Sujatha, Sharma, Nimisha Raj, Robertson, Brian, Schrager, Lewis K, and Weller, Charlotte L
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VACCINE development ,TUBERCULOSIS vaccines ,BCG vaccines ,AIDS vaccines ,DRUG development - Abstract
Tools to evaluate and accelerate tuberculosis (TB) vaccine development are needed to advance global TB control strategies. Validated human infection studies for TB have the potential to facilitate breakthroughs in understanding disease pathogenesis, identify correlates of protection, develop diagnostic tools, and accelerate and de-risk vaccine and drug development. However, key challenges remain for realizing the clinical utility of these models, which require further discussion and alignment among key stakeholders. In March 2023, the Wellcome Trust and the International AIDS Vaccine Initiative convened international experts involved in developing both TB and bacillus Calmette-Guérin (BCG) human infection studies (including mucosal and intradermal challenge routes) to discuss the status of each of the models and the key enablers to move the field forward. This report provides a summary of the presentations and discussion from the meeting. Discussions identified key issues, including demonstrating model validity, to provide confidence for vaccine developers, which may be addressed through demonstration of known vaccine effects (eg, BCG vaccination in specific populations), and by comparing results from field efficacy and human infection studies. The workshop underscored the importance of establishing safe and acceptable studies in high-burden settings, and the need to validate >1 model to allow for different scientific questions to be addressed as well as to provide confidence to vaccine developers and regulators around use of human infection study data in vaccine development and licensure pathways. [ABSTRACT FROM AUTHOR]
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- 2024
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27. COVID-19 Vaccine Efficacy in Participants With Weakened Immune Systems From 4 Randomized Controlled Trials.
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Sherman, Amy C, Tuan, Jessica, Cantos, Valeria D, Adeyiga, Oladunni, Mahoney, Scott, Ortega-Villa, Ana M, Tillman, Amy, Whitaker, Jennifer, Davis, Amanda S Woodward, Leav, Brett, Hirsch, Ian, Sadoff, Jerald, Dunkle, Lisa M, Gilbert, Peter B, Janes, Holly E, Kublin, James G, Goepfert, Paul A, Kotloff, Karen, Rouphael, Nadine, and Falsey, Ann R
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NUTRITION disorders ,PLACEBOS ,VACCINE effectiveness ,IMMUNOCOMPROMISED patients ,STATISTICAL sampling ,IMMUNE system ,COVID-19 vaccines ,RANDOMIZED controlled trials ,PHARMACEUTICAL industry - Abstract
Background Although the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions. Methods A post hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, coronavirus disease 2019 (COVID-19) vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a "tempered immune system" (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS individuals starting at 14 days after completion of the primary series through the blinded phase for each of the 4 trials. An analysis of participants living with well-controlled human immunodeficiency virus was conducted using the same methods. Results A total of 3852/30 351 (12.7%) Moderna participants, 3088/29 868 (10.3%) Novavax participants, 3549/32 380 (11.0%) AstraZeneca participants, and 5047/43 788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (vs placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants versus non-TIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with human immunodeficiency virus. Conclusions For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared with those with non-TIS in the 4 COVID-19 vaccine randomized controlled efficacy trials. [ABSTRACT FROM AUTHOR]
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- 2024
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28. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial
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Bekker, Linda-Gail, Moodie, Zoe, Grunenberg, Nicole, Laher, Fatima, Tomaras, Georgia D, Cohen, Kristen W, Allen, Mary, Malahleha, Mookho, Mngadi, Kathryn, Daniels, Brodie, Innes, Craig, Bentley, Carter, Frahm, Nicole, Morris, Daryl E, Morris, Lynn, Mkhize, Nonhlanhla N, Montefiori, David C, Sarzotti-Kelsoe, Marcella, Grant, Shannon, Yu, Chenchen, Mehra, Vijay L, Pensiero, Michael N, Phogat, Sanjay, DiazGranados, Carlos A, Barnett, Susan W, Kanesa-thasan, Niranjan, Koutsoukos, Marguerite, Michael, Nelson L, Robb, Merlin L, Kublin, James G, Gilbert, Peter B, Corey, Lawrence, Gray, Glenda E, and McElrath, M Juliana
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- 2018
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29. A Randomized Trial Evaluating the Prophylactic Activity of DSM265 Against Preerythrocytic Plasmodium falciparum Infection During Controlled Human Malarial Infection by Mosquito Bites and Direct Venous Inoculation
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Murphy, Sean C., Duke, Elizabeth R., Shipman, Kelly J., Jensen, Ryan L., Fong, Youyi, Ferguson, Sue, Janes, Holly E., Gillespie, Kevin, Seilie, Annette M., Hanron, Amelia E., Rinn, Laurie, Fishbaugher, Matthew, VonGoedert, Tracie, Fritzen, Emma, Kappe, Stefan H., Chang, Ming, Sousa, Jason C., Marcsisin, Sean R., Chalon, Stephan, Duparc, Stephan, Kerr, Nicola, Möhrle, Jörg J., Andenmatten, Nicole, Rueckle, Thomas, and Kublin, James G.
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- 2018
30. Neutralizing antibody responses over time in demographically and clinically diverse individuals recovered from SARS-CoV-2 infection in the United States and Peru: A cohort study
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Karuna, Shelly, Li, Shuying Sue, Grant, Shannon, Walsh, Stephen R., Frank, Ian, Casapia, Martin, Trahey, Meg, Hyrien, Ollivier, Fisher, Leigh, Miner, Maurine D., Randhawa, April K., Polakowski, Laura, Kublin, James G., Corey, Lawrence, and Montefiori, David
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Demographic aspects ,Patient outcomes ,Health aspects ,Antigen-antibody reactions -- Health aspects ,Immune response -- Health aspects ,COVID-19 -- Patient outcomes -- Demographic aspects - Abstract
Author(s): Shelly Karuna 1,*, Shuying Sue Li 1, Shannon Grant 1, Stephen R. Walsh 2, Ian Frank 3, Martin Casapia 4, Meg Trahey 1, Ollivier Hyrien 1, Leigh Fisher 1, [...], Background People infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) experience a wide range of clinical manifestations, from asymptomatic and mild illness to severe illness and death, influenced by age and a variety of comorbidities. Neutralizing antibodies (nAbs) are thought to be a primary immune defense against the virus. Large, diverse, well-characterized cohorts of convalescent individuals provide standardized values to benchmark nAb responses to past SARS-CoV-2 infection and define potentially protective levels of immunity. Methods and findings This analysis comprises an observational cohort of 329 HIV-seronegative adults in the United States (n = 167) and Peru (n = 162) convalescing from SARS-CoV-2 infection from May through October 2020. The mean age was 48 years (range 18 to 86), 54% of the cohort overall was Hispanic, and 34% identified as White. nAb titers were measured in serum by SARS-CoV-2.D614G Spike-pseudotyped virus infection of 293T/ACE2 cells. Multiple linear regression was applied to define associations between nAb titers and demographic variables, disease severity and time from infection or disease onset, and comorbidities within and across US and Peruvian cohorts over time. nAb titers peaked 28 to 42 days post-diagnosis and were higher in participants with a history of severe Coronavirus Disease 2019 (COVID-19) (p 55 years, male sex assigned at birth, and, in some cases, body mass index were also independently associated with higher nAb titers, whereas hypertension was independently associated with lower nAb titers. nAb titers did not differ by race, underlying pulmonary disease or smoking. Two months post-enrollment, nAb ID50 (ID80) titers declined 3.5 (2.8)-fold overall. Study limitations in this observational, convalescent cohort include survivorship bias and missing early viral loads and acute immune responses to correlate with the convalescent responses we observed. Conclusions In summary, in our cohort, nAb titers after SARS-CoV-2 infection peaked approximately 1 month post-diagnosis and varied by age, sex assigned at birth, disease severity, and underlying comorbidities. Our data show great heterogeneity in nAb responses among people with recent COVID-19, highlighting the challenges of interpreting natural history studies and gauging responses to vaccines and therapeutics among people with recent infection. Our observations illuminate potential correlations of demographic and clinical characteristics with nAb responses, a key element for protection from COVID-19, thus informing development and implementation of preventative and therapeutic strategies globally. Trial registration ClinicalTrials.gov NCT04403880.
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- 2021
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31. Mobile Phone Questionnaires for Sexual Risk Data Collection Among Young Women in Soweto, South Africa
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Dietrich, Janan J., Lazarus, Erica, Andrasik, Michele, Hornschuh, Stefanie, Otwombe, Kennedy, Morgan, Cecilia, Isaacs, Abby J., Huang, Yunda, Laher, Fatima, Kublin, James G., Gray, Glenda E., and for the HVTN 915 study team
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- 2018
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32. Selection of HIV vaccine candidates for concurrent testing in an efficacy trial
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Huang, Ying, DiazGranados, Carlos, Janes, Holly, Huang, Yunda, deCamp, Allan C, Metch, Barbara, Grant, Shannon, Sanchez, Brittany, Phogat, Sanjay, Koutsoukos, Marguerite, Kanesa-Thasan, Niranjan, Bourguignon, Patricia, Collard, Alix, Buchbinder, Susan, Tomaras, Georgia D, McElrath, Julie, Gray, Glenda, Kublin, James G, Corey, Lawrence, and Gilbert, Peter B
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- 2016
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33. HIV vaccines beyond COVID-19: merits of trust
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Kublin, James G.
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Control ,Prevention ,Analysis ,Risk factors ,Public opinion ,AIDS vaccines -- Public opinion ,HIV infections -- Risk factors -- Prevention ,Epidemics -- Control -- Prevention -- United States ,COVID-19 vaccines -- Public opinion ,Health behavior -- Analysis ,HIV infection -- Risk factors -- Prevention - Abstract
As contagion of sickness makes sickness, contagion of trust can make trust. In Distrust of Merits, Marianne Moore [1] The astonishing success of the SARS?CoV?2 vaccines reveals important aspects of [...]
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- 2021
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34. Daily Vaginal Swabs and Mobile Phone Sex Report for Assessing HIV Virion Exposure Prospectively Among a Cohort of Young Sexually Active Women in South Africa (HVTN 915)
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Lemos, Maria P., Lazarus, Erica, Isaacs, Abby, Dietrich, Janan, Morgan, Cecilia, Huang, Yunda, Grove, Doug, Andrasik, Michele, Laher, Fatima, Hural, John, Chung, Eva, Dragavon, Joan, Puren, Adrian, Gulati, Reena K., Coombs, Robert, McElrath, Margaret Juliana, Gray, Glenda, and Kublin, James G.
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- 2019
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35. Are Clade Specific HIV Vaccines a Necessity? An Analysis Based on Mathematical Models
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Dimitrov, Dobromir, Kublin, James G., Ramsey, Scott, and Corey, Lawrence
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- 2015
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36. Persistence of Sulfadoxine-Pyrimethamine Resistance Despite Reduction of Drug Pressure in Malawi
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Artimovich, Elena, Schneider, Kristan, Taylor, Terrie E., Kublin, James G., Dzinjalamala, Fraction K., Escalante, Ananias A., Plowe, Christopher V., Laufer, Miriam K., and Takala-Harrison, Shannon
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- 2015
37. Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials
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Moodie, Zoe, Walsh, Stephen R., Laher, Fatima, Maganga, Lucas, Herce, Michael E., Naidoo, Sarita, Hosseinipour, Mina C., Innes, Craig, Bekker, Linda-Gail, Grunenberg, Nicole, Mann, Philipp, Yu, Chenchen, deCamp, Allan C., Miner, Maurine D., Yates, Nicole L., Heptinstall, Jack, Mkhize, Nonhlanhla N., Dintwe, One, Frahm, Nicole, Cohen, Kristen W., Allen, Mary, Hutter, Julia, Wagner, Ralf, Pantaleo, Giuseppe, McElrath, M. Juliana, Tomaras, Georgia D., Morris, Lynn, Montefiori, David C., Andersen-Nissen, Erica, Gray, Glenda E., Gilbert, Peter B., and Kublin, James G.
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Drug therapy ,Clinical trials ,AIDS vaccines ,Genetic research ,HIV antigens ,HIV -- Drug therapy ,DNA ,Vaccination ,T cells - Abstract
Author(s): Zoe Moodie 1,*, Stephen R. Walsh 2,3,4, Fatima Laher 5, Lucas Maganga 6, Michael E. Herce 7, Sarita Naidoo 8, Mina C. Hosseinipour 9, Craig Innes 10, Linda-Gail Bekker [...], Background DNA plasmids promise a pragmatic alternative to viral vectors for prime-boost HIV-1 vaccines. We evaluated DNA plasmid versus canarypox virus (ALVAC) primes in 2 randomized, double-blind, placebo-controlled trials in southern Africa with harmonized trial designs. HIV Vaccine Trials Network (HVTN) 111 tested DNA plasmid prime by needle or needleless injection device (Biojector) and DNA plasmid plus gp120 protein plus MF59 adjuvant boost. HVTN 100 tested ALVAC prime and ALVAC plus gp120 protein plus MF59 adjuvant boost (same protein/adjuvant as HVTN 111) by needle. Methods and findings The primary endpoints for this analysis were binding antibody (bAb) responses to HIV antigens (gp120 from strains ZM96, 1086, and TV1; variable 1 and 2 [V1V2] regions of gp120 from strains TV1, 1086, and B.CaseA, as 1086 V1V2 and B.CaseA were correlates of risk in the RV144 efficacy trial), neutralizing antibody (nAb) responses to pseudoviruses TV1c8.2 and MW925.26, and cellular responses to vaccine-matched antigens (envelope [Env] from strains ZM96, 1086, and TV1; and Gag from strains LAI and ZM96) at month 6.5, two weeks after the fourth vaccination. Per-protocol cohorts included vaccine recipients from HVTN 100 (n = 186, 60% male, median age 23 years) enrolled between February 9, 2015, and May 26, 2015 and from HVTN 111 (n = 56, 48% male, median age 24 years) enrolled between June 21, 2016, and July 13, 2017. IgG bAb response rates were 100% to 3 Env gp120 antigens in both trials. Response rates to V1V2 were lower and similar in both trials except to vaccine-matched 1086 V1V2, with rates significantly higher for the DNA-primed regimen than the ALVAC-primed regimen: 96.6% versus 72.7% (difference = 23.9%, 95% CI 15.6%-32.2%, p < 0.001). Among positive responders, bAb net mean fluorescence intensity (MFI) was significantly higher with the DNA-primed regimen than ALVAC-primed for 1086 V1V2 (geometric mean [GM] 2,833.3 versus 1,200.9; ratio = 2.36, 95% CI 1.42-3.92, p 98% in both trials, with significantly higher 50% inhibitory dilution (ID.sub.50) among DNA-primed positive responders (n = 53) versus ALVAC-primed (n = 182) to tier 1A MW965.26 (GM 577.7 versus 265.7, ratio = 2.17, 95% CI 1.67-2.83, p < 0.001) and to TV1c8.2 (GM 187.3 versus 100.4, ratio = 1.87, 95% CI 1.48-2.35, p < 0.001). CD4+ T-cell response rates were significantly higher with DNA plasmid prime via Biojector than ALVAC prime (91.4% versus 52.8%, difference = 38.6%, 95% CI 20.5%-56.6%, p < 0.001 for ZM96.C; 88.0% versus 43.1%, difference = 44.9%, 95% CI 26.7%-63.1%, p < 0.001 for 1086.C; 55.5% versus 2.2%, difference = 53.3%, 95% CI 23.9%-82.7%, p < 0.001 for Gag LAI/ZM96). The study's main limitations include the nonrandomized comparison of vaccines from 2 different trials, the lack of data on immune responses to other non-vaccine-matched antigens, and the uncertain clinical significance of the observed immunological effects. Conclusions In this study, we found that further investigation of DNA/protein regimens is warranted given enhanced immunogenicity to the V1V2 correlates of decreased HIV-1 acquisition risk identified in RV144, the only HIV vaccine trial to date to show any efficacy.
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- 2020
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38. HIV-1 Infection and Antibodies to Plasmodium falciparum in Adults
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Hasang, Wina, Dembo, Edson G., Wijesinghe, Rushika, Molyneux, Malcolm E., Kublin, James G., and Rogerson, Stephen
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- 2014
39. Complete attenuation of genetically engineered Plasmodium falciparum sporozoites in human subjects
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Kublin, James G., Mikolajczak, Sebastian A., Sack, Brandon K., Fishbaugher, Matt E., Seilie, Annette, Shelton, Lisa, VonGoedert, Tracie, Firat, Melike, Magee, Sara, Fritzen, Emma, Betz, Will, Kain, Heather S., Dankwa, Dorender A., Steel, Ryan W. J., Vaughan, Ashley M., Noah Sather, D., Murphy, Sean C., and Kappe, Stefan H. I.
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- 2017
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40. Safety and Comparative Immunogenicity of an HIV-1 DNA Vaccine in Combination with Plasmid Interleukin 12 and Impact of Intramuscular Electroporation for Delivery
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Kalams, Spyros A., Parker, Scott D., Elizaga, Marnie, Metch, Barbara, Edupuganti, Srilatha, Hural, John, De Rosa, Stephen, Carter, Donald K., Rybczyk, Kyle, Frank, Ian, Fuchs, Jonathan, Koblin, Beryl, Kim, Denny H., Joseph, Patrice, Keefer, Michael C., Baden, Lindsey R., Eldridge, John, Boyer, Jean, Sherwat, Adam, Cardinali, Massimo, Allen, Mary, Pensiero, Michael, Butler, Chris, Khan, Amir S., Yan, Jian, Sardesai, Niranjan Y., Kublin, James G., and Weiner, David B.
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- 2013
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41. Utilizing gnotobiotic models to inform the role of the microbiome in vaccine response heterogeneity
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Cram, Jacob A., Hager, Kevin W., and Kublin, James G.
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- 2018
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42. Comparative Cell-Mediated Immunogenicity of DNA/DNA, DNA/Adenovirus Type 5 (Ad5), or Ad5/Ad5 HIV-1 Clade B gag Vaccine Prime-Boost Regimens
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Asmuth, David M., Brown, Elizabeth L., DiNubile, Mark J., Sun, Xiao, Rio, Carlos del, Harro, Clayton, Keefer, Michael C., Kublin, James G., Dubey, Sheri A., Kierstead, Lisa S., Casimiro, Danilo R., Shiver, John W., Robertson, Michael N., Quirk, Erin K., and Mehrotra, Devan V.
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- 2010
43. Safety and efficacy of the HVTN 503/Phambili Study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study
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Gray, Glenda E, Allen, Mary, Moodie, Zoe, Churchyard, Gavin, Bekker, Linda-Gail, Nchabeleng, Maphoshane, Mlisana, Koleka, Metch, Barbara, de Bruyn, Guy, Latka, Mary H, Roux, Surita, Mathebula, Matsontso, Naicker, Nivashnee, Ducar, Constance, Carter, Donald K, Puren, Adrien, Eaton, Niles, McElrath, M Julie, Robertson, Michael, Corey, Lawrence, and Kublin, James G
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- 2011
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44. HIV-Malaria Interactions: Don't Forget the Drugs [with Response]
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Andrews, Katherine T., Gatton, Michelle L., Skinner-Adams, Tina S., McCarthy, James S., Gardiner, Donald L., Abu-Raddad, Laith J., Patnaik, Padmaja, and Kublin, James G.
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- 2007
45. Dual Infection with HIV and Malaria Fuels the Spread of Both Diseases in Sub-Saharan Africa
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Abu-Raddad, Laith J., Patnaik, Padmaja, and Kublin, James G.
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- 2006
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46. HIV Infection and Malaria: Understanding the Interactions
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Kublin, James G. and Steketee, Richard W.
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- 2006
47. Effects of HIV-1 Serostatus, HIV-1 RNA Concentration, and CD4 Cell Count on the Incidence of Malaria Infection in a Cohort of Adults in Rural Malawi
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Patnaik, Padmaja, Jere, Charles S., Miller, William C., Hoffman, Irving F., Wirima, Jack, Pendame, Richard, Meshnick, Steven R., Taylor, Terrie E., Molyneux, Malcolm E., and Kublin, James G.
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- 2005
48. Plasmodium 18S Ribosomal RNA Biomarker Clearance After Food and Drug Administration–Approved Antimalarial Treatment in Controlled Human Malaria Infection Trials.
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Chavtur, Chris, Staubus, Weston J, Ho, Mabel, Hergott, Dianna E B, Seilie, Annette M, Healy, Sara, Duffy, Patrick, Jackson, Lisa, Talley, Angela, Kappe, Stefan H I, Hoffman, Stephen L, Richie, Thomas L, Kublin, James G, Chang, Ming, and Murphy, Sean C
- Abstract
Background Sensitive molecular assays, such as quantitative reverse-transcription polymerase chain reaction (qRT-PCR) of Plasmodium 18S ribosomal RNA (rRNA), are increasingly the primary method of detecting infections in controlled human malaria infection (CHMI) trials. However, thick blood smears (TBSs) remain the main method for confirming clearance of parasites after curative treatment, in part owing to uncertainty regarding biomarker clearance rates. Methods For this analysis, 18S rRNA qRT-PCR data were compiled from 127 Plasmodium falciparum –infected participants treated with chloroquine or atovaquone-proguanil in 6 CHMI studies conducted in Seattle, Washington, over the past decade. A survival analysis approach was used to compare biomarker and TBS clearance times among studies. The effect of the parasite density at which treatment was initiated on clearance time was estimated using linear regression. Results The median time to biomarker clearance was 3 days (interquartile range, 3–5 days), while the median time to TBS clearance was 1 day (1–2 days). Time to biomarker clearance increased with the parasite density at which treatment was initiated. Parasite density did not have a significant effect on TBS clearance. Conclusions The Plasmodium 18S rRNA biomarker clears quickly and can be relied on to confirm the adequacy of Food and Drug Administration–approved treatments in CHMI studies at nonendemic sites. [ABSTRACT FROM AUTHOR]
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- 2023
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49. Safety and Immunogenicity of Ad26-vectored HIV Vaccine with Mosaic Immunogens and a Novel Mosaic Envelope Protein in HIV-uninfected Adults: A Phase 1/2a Study.
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Stieh, Daniel J, Barouch, Dan H, Comeaux, Christy, Sarnecki, Michal, Stephenson, Kathryn E, Walsh, Stephen R, Sawant, Sheetal, Heptinstall, Jack, Tomaras, Georgia D, Kublin, James G, McElrath, M Juliana, Cohen, Kristen W, Rosa, Stephen C De, Alter, Galit, Ferrari, Guido, Montefiori, David, Mann, Philipp, Nijs, Steven, Callewaert, Katleen, and Goepfert, Paul A
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AIDS vaccines ,IMMUNE response ,C++ ,CLINICAL trial registries ,HIV infections - Abstract
Background: Developing a cross-clade, globally effective HIV vaccine remains crucial for eliminating HIV.Methods: This placebo-controlled, double-blind, phase 1/2a study (NCT02935686) enrolled healthy HIV-uninfected adults at low risk for HIV infection. They were randomized (1:4:1) to receive 4 doses of an adenovirus 26-based HIV-1 vaccine encoding 2 mosaic Gag and Pol, and 2 mosaic Env proteins plus adjuvanted clade C gp140 (referred to here as clade C regimen), bivalent protein regimen (clade C regimen plus mosaic gp140), or placebo. Primary endpoints were safety and antibody responses.Results: 152/155 participants (clade C [n = 26], bivalent protein [n = 103], placebo [n = 26]) received ≥1 injection. The highest adverse event (AE) severity was grade 3 (local pain/tenderness: 12%, 2%, and 0% of the respective groups; solicited systemic AEs: 19%, 15%, 0%). HIV-1 mosaic gp140-binding antibody titers were 79,595 ELISA units [EU]/mL and 137,520 EU/mL in the clade C and bivalent protein groups (P < .001) post-dose 4 and 16,862 EU/mL and 25,162 EU/mL 6 months later. Antibody response breadth against clade C gp140 and clade C/non-clade C gp120 was highest in the bivalent protein group.Conclusions: Adding mosaic gp140 to the clade C regimen increased and broadened the elicited immune response without compromising safety or clade C responses. [ABSTRACT FROM AUTHOR]- Published
- 2023
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50. Rare, Highly Pyrimethamine-Resistant Alleles of the Plasmodium falciparum Dihydrofolate Reductase Gene from 5 African Sites
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Bates, Sarah J., Winstanley, Peter A., Watkins, William M., Alloueche, Ali, Bwika, Juma, Happi, T. Christian, Kremsner, Peter G., Kublin, James G., Premji, Zul, and Sibley, Carol Hopkins
- Published
- 2004
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