2 results on '"Diop, Samba"'
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2. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries
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Badio, Moses, Lhomme, Edouard, Kieh, Mark, Beavogui, Abdoul Habib, Kennedy, Stephen B., Doumbia, Seydou, Leigh, Bailah, Sow, Samba O., Diallo, Alpha, Fusco, Daniela, Kirchoff, Matthew, Termote, Monique, Vatrinet, Renaud, Wentworth, Deborah, Esperou, Helène, Lane, H. Clifford, Pierson, Jerome, Watson-Jones, Deborah, Roy, Céline, D’Ortenzio, Eric, Greenwood, Brian, Chêne, Genevieve, Richert, Laura, Neaton, James D., Yazdanpanah, Yazdan, Abdoulaye, Coulibaly, Aboulhab, Jamilia, Akoo, Pauline, Akpa, Esther, Akpata, Robert, Albert, Sara, Ale, Boni Maxime, C. Andrews, Benetta, Anoma, Stephane, Assiandi, Saw-San, Augier, Augustin, Awuondo, Ken, Bagayoko, Aminata, Bakare, Nyasha, Balde, Abby, Bangura, Lamin Molecule, Barrington, Kesha, Barte de Saint Fare, Eric, Baseler, Beth, Bauder, Ali, Bauduin, Claire, Bawo, Luke, Habib Beavogui, Abdoul, Belson, Michael, Bererd, Marion, Beyslow, Teedoh, Binachon, Blandine, Blie, Julie, Bockstal, Viki, Boire, Youba, Boison, Patricia, Bolay, Fatorma, Boly, Aliou, Gael Borg, Anne, Bowers, Donna, Browne, Sarah, Cagniard, Barbara, Cahill, Kelly, Abdoulaye Camara, Aissata, Camara, Keira, Camara, Modet, Campion, Cécilia, Cash, Jennifer, Pin Chai, Siew, Chambelin, Francois, Chieck, Keita, Chêne, Geneviève, Ciancia, Séverine, Ndiaga Cisse, Papa, Clide, Elfrida, Colin, Céline, Coller, Beth-Ann, Siaka Conde, Djélikan, Cone, Katherine, Connor, Laurie, Connor, Nicholas, Boye Cooper, Joseph, Couffin-Cardiergues, Sandrine, Coulibaly, Fatoumata, Coulibaly, Mariam, Dabakuyo-Yonli, Sandrine, Dabitao, Djeneba, Damerval, Thierry, Davis, Bionca, Fadlu Deen, Gibrilla, Dekeyster, Eline, Delfraissy, Jean-François, Delmas, Christelle, Dembele, Rokia, Diakite, Mahamadou, Saliou Diallo, Mamadou, Diarra, Ayouba, Diawara, Oualy, Dighero-kemp, Bonnie, Diop, Samba, Diouf, Waly, Doepel, Laurie, Moise Doumbia, Moussa, Douoguih, Macaya, DuChêne, Alain, Duvenhage, Michael, Eckes, Risa Eckes, Egan, Avril, Enria, Luisa, Espérou, Hélène, Etienne, Cécile, Eyler, Allison, Faye, Sylvain, Fernandez, José, Fleck, Suzanne, Fofana, Vemy, Franklin, Kokulo, Gaddah, Auguste, Gaignet, Marylène, Gallagher, Katherine, Garcia Gozalbes, Julia, Grandits, Greg, Gray, Maima, Greijer, Astrid, Grue, Louis, Grund, Birgit, Guindo, Oumar, Gupta, Swati, Haidara, Fadima, Hamze, Benjamin, Hancox, Emma, Hart, Gavin, Hébert, Jean-Christophe, Heijnen, Esther, Hensley, Patricia, Hensley, Lisa, Higgs, Elisabeth, Hilton, Trudi, Holley, Preston, Hoover, Marie, Howard, Natasha, Hughes, Melissa, Ilo, Dicko, Imes, Jen, Irvine, Skip, Ishola, David, Jacob, Will, Jato, Yvonne, Johnson, Melvin, Jusu, Morrison, Sidiki Kaba, Aboubacar, Kante, Myriam, Katoudi, Judith, Keita, Sakoba, Kennedy, Stephen, Jide Keshinro, Babajide, Khon, Brian, Kiawu, Hassan, Kirchoff, Matt, Kodio, Mamoudou, Koivogui, Lamine, Kombi, Tania, Kopka, Stacy, Kowuors, Dickens, Lacabaratz, Christine, Lacarra, Boris, Lambert, Laurie, Lane, Cliff, Lee, Shona, Lees, Shelley, Lefevre, Annabelle, Lemarcis, Frederic, Lévy, Yves, Levy-Marchal, Claire, Lewally, Jemilla, Leyssen, Maarten, Liu, Ken, Lowe, Brett, Lysander, Julia, Madelaine, Claire, Mahamadou, Ibrah, Manno, Daniela, Marchand, Johnathan, Marynissen, Siegfried, Massaquoi, Moses B.F., Masson, Laure, Matard, Charly, Matthew, Onorato, McCullough, John, Mercier, Noemie, Michavila, Pauline, Miller, Tracey, Miranda, Alejandra, Mohamed, Soumaya, Mooney, Tom, Morsch, Hans, Muamba, Dally, Lukoo Ndamenyaa, Rita, Neaton, James, Neboua, Désiré, Nelson, Micki, Newell, Kevin, Nguyen, Vinh-kim, Nielsen, Leslie, Niouma, Millimouno, Offergeld, Kim, Onorato, Matthew, Onwuchekwa, Uma, Orsega, Susan, Ortega-Perez, Inmaculada, Osborne, Cynthia, Otieno, Tuda, Patel, Sushma, Peiffer-Smadj, Nathan, Phillips, Robert, Piot, Peter, Piziali, Micheal, Pong, Stephany, Proffitt, Calvin, Quach, Alexandre, Ramers-verhoeven, Corina, Randunu, Nadeeka, Rivière, Priscille, Robinson, Cynthia, Van Roey, Griet, Falk Russell, Amy, Samai, Sibiry Samake, Mohamed, Sangare, Ballan, Sanogo, Ibrahim, Sadio Sarro, Yeya, Sarro, Sadio, Saville, Mélanie, Sawadogo, Serge, Schvartz, Maxime, Schwimmer, Christine, Secka, Fatou, Seraphin, Jacques, Shelley, Denise, Siddiqui, Sophia, Simon, Jakub, Simpson, Shelly, Muyisa Sivahera, Billy, Skip, Irvine, Slater, Karen, Smolskis, Mary, Smout, Elizabeth, Snowden, Emily, Soutthiphong, Anne-Aygline, Sow, Samba, Sow, Ydrissa, Splinter, Daniel, Spreng, Simone, Stapleton, Helen, Stoop, Jeroen, Sweeney, Mary, Tamba, Sienneh, Tapia, Mili, Tegli, Jemee, Thiebaut, Rodolphe, Thompson, Greg, Tierney, John, Touré, Abdoulaye, Traina, Stacey, Traore, Awa, Traore, Moussa, Tyee, Tijili, Vallée, David, Van Der Donck, Katrien V, Verbruggen, Nadia, Vincent, Corine, Vogel, Susan, Wallet, Cedrick, Wesseh, Cecelia, Whitworth, Jimmy, Wiedemann, Aurelie, Willems, Wouter, Williams, Julian, Wilson, Barthalomew, Wissedi, Njoh, Wolf, Jayanthi, Woods, Ian, Wurie, Alie, Yamadjako, Delphine, Yaradouno, Marcel, Zeggani, Zara, Statistics In System biology and Translational Medicine (SISTM), Inria Bordeaux - Sud-Ouest, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)- Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), PREVAIL, Centre National de Formation et de Recherche en Santé Rurale [Maférinyah, Guinée] (CNFRSR), Malaria Research and Training Center [Bamako, Mali], Université de Bamako, University of Sierra Leone (USL), Institut National de Santé Publique [Bamako] = National Institute of Research on Public Health (INSP), ANRS - Maladies infectieuses émergentes (ANRS - MIE), Institut National de la Santé et de la Recherche Médicale (INSERM), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Minnesota [Twin Cities] (UMN), University of Minnesota System, Pôle de Recherche Clinique [Paris] (PRC), National Institute of Allergy and Infectious Diseases [Bethesda] (NIAID-NIH), National Institutes of Health [Bethesda] (NIH), and London School of Hygiene and Tropical Medicine (LSHTM)
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[SDV]Life Sciences [q-bio] - Abstract
International audience; Abstract Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those
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