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

作者：Moses Badio, Édouard Lhomme, Mark Kieh, Abdoul Habib Béavogui, Stephen B. Kennedy, Seydou Doumbia, Bailah Leigh, Samba O. Sow, Alpha Diallo, Daniela Fusco, Matthew Kirchoff, Monique Termote, Renaud Vatrinet, Deborah Wentworth, Hélène Espérou, H. Clifford Lane, Jérôme Pierson, Deborah Watson‐Jones, Céline Roy, Éric D’Ortenzio, Brian Greenwood, Geneviève Chêne, Laura Richert, James D. Neaton, Yazdan Yazdanpanah, the PREVAC study team, Abdoulaye Coulibaly, Jamilia Aboulhab, Pauline Akoo, Esther Akpa, Robert Akpata, Sara Albert, Boni Maxime Ale, Benetta C. Andrews, Stephane Anoma, Saw-San Assiandi, Augustin Augier, Ken Awuondo, Moses Badio, Aminata Bagayoko, Nyasha Bakare, Abby Balde, Lamin Molecule Bangura, Kesha Barrington, Eric Barte de Saint Fare, Beth Baseler, Ali Bauder, Claire Bauduin, Luke Bawo, Abdoul Habib Béavogui, Michael Belson, Marion Bererd, Teedoh Beyslow, Blandine Binachon, Julie Blie, Viki Bockstal, Youba Boire, Patricia Boison, Fatorma Bolay, Aliou Boly, Anne Gael Borg, Donna Bowers, Sarah Browne, Barbara Cagniard, Kelly Cahill, Aissata Abdoulaye Camara, Keira Camara, Modet Camara, Cécilia Campion, Jennifer Cash, Siew Pin Chai, Francois Chambelin, Keita Chieck, Geneviève Chêne, Séverine Ciancia, Papa Ndiaga Cissé, Elfrida Clide, Céline Colin, Beth-Ann Coller, Djélikan Siaka Conde, Katherine Cone, Laurie Connor, Nicholas E. Connor, Joseph B. Cooper, Sandrine Couffin-Cardiergues, Fatoumata Coulibaly, Mariam Coulibaly, Tienhan Sandrine Dabakuyo‐Yonli, Djénéba Dabitao, Thierry Damerval, Bionca Davis, Gibrilla F. Deen, Eline Dekeyster, Jean‐François Delfraissy, Christelle Delmas, Rokia Dembele, Mahamadou Diakité, Alpha Diallo, Mamadou Saliou Diallo, Ayouba Diarra, Oualy Diawara, Bonnie Dighero-Kemp, Samba Diop, Waly Diouf, Laurie Doepel, Éric D’Ortenzio, Seydou Doumbia, Moussa Doumbia, Macaya Douoguih, Alain DuChêne, Michael Duvenhage, Risa Eckes, Avril Egan, Luisa Enria, Hélène Espérou, Cécile Etienne, Allison Eyler, Sylvain Landry Faye, José Fernandez, Suzanne Fleck, Vemy Fofana, Kokulo Franklin, Daniela Fusco, Auguste Gaddah, Marylène Gaignet, Katherine E. Gallagher, Julia García Gozalbes, Greg Grandits, Maima Gray, Brian Greenwood, Astrid E. Greijer, Louis Grue, Birgit Grund, Oumar Guindo, Swati Gupta, Fadima Cheick Haidara, Benjamin Hamzé, Emma Hancox, Gavin Hart, Jean-Christophe Hébert, Esther Heijnen, Patricia Hensley, Lisa E. Hensley, Elisabeth Higgs, Trudi Hilton, Preston Holley, Marie L. Hoover, Natasha Howard, Melissa E. Hughes, Dicko Ilo, Jen Imes, Skip Irvine, David Ishola, Will Jacob, Yvonne Jato, Melvin Johnson, Morrison Jusu, Aboubacar Kaba, Myriam Kanté, Judith Katoudi, Sakoba Keita, Stephen Kennedy, Babajide Keshinro, Brian Khon, Hassan Kiawu, Mark Kieh, Matt Kirchoff, Mamoudou Kodio, Lamine Koivogui, Tania Kombi, Stacy Kopka, Dickens Kowuors, Christine Lacabaratz, Boris Lacarra, Laurie Lambert, Cliff Lane, Shona Lee, Shelley Lees, Annabelle Lefevre, Bailah Leigh, Frederic Lemarcis, Yves Lévy, Claire Levy-Marchal, Jemilla Lewally, Maarten Leyssen, Édouard Lhomme, Ken Liu, Brett Lowe, Julia Lysander, Claire Madelaine, Ibrah Mahamadou, Daniela Manno, Johnathan Marchand, Siegfried Marynissen, Moses Massaquoi, Laure Masson, Charly Matard, Onorato Matthew, John McCullough, Noémie Mercier, Pauline Michavila, Tracey Miller, Alejandra Miranda, Soumaya Mohamed, Tom Mooney, Hans H. C. Morsch, Dally Muamba, Rita Lukoo Ndamenyaa, James D. Neaton, Désiré Neboua, Micki Nelson, Kevin Newell, Vinh‐Kim Nguyen, Leslie Nielsen, Millimouno Niouma, Kim Offergeld, Matthew Onorato, Uma Onwuchekwa, Susan Orsega, Inmaculada Ortega‐Pérez, Cynthia Osborne, Tuda Otieno, Sushma Patel, Nathan Peiffer-Smadj, Robert Phillips, Jérôme Pierson, Peter Piot, Micheal Piziali, Stéphany Pong, Calvin Proffitt, Alexandre Quach, Corina Ramers-verhoeven, Nadeeka Randunu, Laura Richert, Priscille Rivière, Cynthia Robinson, Griet Van Roey, Céline Roy, Amy Falk Russell, Sibiry Samake Mohamed Samai, Ballan Sangare, Ibrahim Sanogo, Yeya Sadio Sarro, Sadio Sarro, Mélanie Saville, Serge Sawadogo, Maxime Schvartz, Christine Schwimmer, Fatou Secka, J Seraphin, Denise Shelley, Sophia Siddiqui, Jakub K. Simon, Shelly Simpson, Billy Muyisa Sivahera, Irvine Skip, Karen Slater, Mary Smolskis, Elizabeth Smout, Emily Snowden, Anne-Aygline Soutthiphong, Samba O. Sow, Ydrissa Sow, Daniel Splinter, Simone Spreng, Helen Stapleton, Jeroen N. Stoop, Mary M. Sweeney, Sienneh Tamba, Mili Tapia, Jemee Tegli, Monique Termote, Rodolphe Thiébaut, Greg Thompson, John Tierney, Abdoulaye Touré, Stacey Traina, Awa Traoré, Moussa Traoré, Tijili Tyee, David Vallée, Katrien V Van Der Donck, Renaud Vatrinet, Nadia Verbruggen, Corine Vincent, Susan Vogel, Cédrick Wallet, Deborah Watson‐Jones, Deborah Wentworth, Cecelia Wesseh, Jimmy Whitworth, Aurélie Wiedemann, Wouter Willems, Julian Williams, Barthalomew Wilson, Njoh Wissedi, Jayanthi Wolf, Ian Woods, Alie Wurie, Delphine Yamadjako, Marcel Yaradouno, Yazdan Yazdanpanah, Zara Zeggani · 发表于：Trials · 年份：2021 · DOI：10.1186/s13063-021-05035-9 · 被引用次数：18 · 研究领域：Viral Infections and Outbreaks Research、Vaccine Coverage and Hesitancy、SARS-CoV-2 and COVID-19 Research

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, Liber...