Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults

作者：Andrew W. Lee, Ken Liu, Édouard Lhomme, Julie Blie, John McCullough, Matthew Onorato, Laurie Connor, Jakub K. Simon, Sheri Dubey, Susan M. VanRheenen, Jonathan Deutsch, Abigail Owens, Amy Morgan, Carolee Welebob, Donna Hyatt, Sunita A. Nair, Benjamin Hamzé, Oumar Guindo, Samba O. Sow, Abdoul Habib Béavogui, Bailah Leigh, Mohamed Samai, Pauline Akoo, Alimamy Serry-Bangura, Suzanne Fleck, Fatou Secka, Brett Lowe, Deborah Watson‐Jones, Céline Roy, Lisa E. Hensley, Mark Kieh, Beth-Ann Coller, the PREVAC Study Team, Jamila Aboulhab, Michelle Aguirre-MacKenzie, Pauline Akoo, Esther Akpa, Robert Akpata, Sara Albert, Boni Maxime Ale, Serry Alimamy-Bangura, Pierre Andong, Benetta C. Andrews, Stephane Anoma, Negin Atri, Augustin Augier, Ken Awuondo, Moses Badio, Aminata Bagayoko, Abby Balde, Joséphine Balssa, 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, Jeanne Billioux, Shere Billouin-Frazier, Blandine Binachon, Julie Blie, Viki Bockstal, Patricia Boison, Fatorma K. Bolay, Aliou Boly, Anne-Gaëlle Borg, Samuel Bosompem, Courtney Bozman, Tyler Brady, Sarah Browne, Barbara Cagniard, Kelly Cahill, Yíngyún Caì, Aissata Abdoulaye Camara, Aboubacar Keira Camara, Alseny Camara, Antoine Campagne, Cécilia Campion, Jennifer Cash, Siew Pin Chai, Francois Chambelin, Michael Chea, Geneviève Chêne, Michelle Chouinard, Florence Chung, Lucy Chung, Séverine Ciancia, Papa Ndiaga Cissé, Elfrida Cline-Cole, 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, Page Crew, Tienhan Sandrine Dabakuyo‐Yonli, Djénéba Dabitao, Thierry Damerval, Bionca Davis, Gibrilla F. Deen, Eline Dekeyster, Jean‐François Delfraissy, Christelle Delmas, Mahamadou Diakité, Alpha Diallo, Mamadou Saliou Diallo, Ayouba Diarra, Samba Diarra, Oualy Diawara, Bonnie Dighero-Kemp, Samba Diop, Waly Diouf, Saurabh Dixit, Barry Djenabou, Laurie Doepel, Éric D’Ortenzio, Seydou Doumbia, Moussa Doumbia, Macaya Douoguih, Nelson Dozier, Natasha Dubois Cauwelaert, Alain DuChêne, Michael Duvenhage, Risa Eckes, Elizabeth Elliott, Luisa Enria, Hélène Espérou, Cécile Etienne, Allison Eyler, Lawrence Fakoli, Mosoka Fallah, Sylvain Landry Faye, John Fayiah, Suzanne Fleck, Vemy Fofana, Karine Fouth Tchos, Kokulo Franklin, Daniela Fusco, Auguste Gaddah, Marylène Gaignet, Katherine E. Gallagher, Harrison Gichini, Julia García Gozalbes, Greg Grandits, Maima Gray, Brian Greenwood, Nico Grobler, Robin Gross, Louis Grue, Birgit Grund, Oumar Guindo, Swati Gupta, Fadima Cheick Haidara, Benjamin Hamzé, Emma Hancox, Jean-Christophe Hébert, Jenny Hendriks, Patricia Hensley, Lisa E. Hensley, Elisabeth Higgs, Trudi Hilton, H. Preston Holley, Marie L. Hoover, Melissa E. Hughes, Dicko Ilo, Skip Irvine, David Ishola, Yvonne Jato, Madison Joe, Melvin Johnson, Aboubacar Kaba, Jonathan C. Kagan, Michael Kamara, Myriam Kanté, Judith Katoudi, Cheick Mohamed Keita, Sakoba Keita, Seykou Keita, Stephen B. Kennedy, Babajide Keshinro, Hassan Kiawu, Mark Kieh, Matthew Kirchoff, Gregory Kocher, Mamoudou Kodio, Brian Köhn, Lamine Koivogui, Richard Kojan, Cece Francis Kolié, Jacques Seraphin Kolié, David Kollie, Stacy L. Kopka, Bockarie Koroma, Dickens Kowuor, Catherine Kpayieli-Freeman, Liane Kwast, Christine Lacabaratz, Boris Lacarra, Laurie Lambert, Courtney Lambeth, Solange Lancrey-javal, H. Clifford Lane, Shadrach Langba, Bolarinde Lawal, Andrew Wen-Tseng Lee, Shona Lee, Shelley Lees, Annabelle Lefevre, Bailah Leigh, Frederic Lemarcis, Yves Lévy, Claire Lévy‐Marchal, Maarten Leyssen, Edouard Lhomme, Janie Liang, Mameni Linga, Ken Liu, Brett Lowe, Julia Lysander, Ibrah Mahamadou, Marvington Mambiah, Daniela Manno, Jonathan Marchand, Lindsay Marron, Moses Massaquoi, Laure Masson, Charly Matard, Steven Mazur, John McCullough, Chelsea McLean, Noémie Mercier, Pauline Michavila, Tracey Miller, Niouma Pascal Millimouno, Alejandra Miranda, Soumaya Mohamed, Tom Mooney, Dally Muamba, James Mulbah, Rita Lukoo Ndamenyaa, James D. Neaton, Désiré Neboua, Micki Nelson, Kevin Newell, Vinh‐Kim Nguyen, Yusupha Njie, Wissedi Njoh, Matthew Onorato, Uma Onwuchekwa, Susan Orsega, Inmaculada Ortega‐Pérez, Cynthia Osborne, Tuda Otieno, Davy Oulaï, Sushma Patel, Danielle Peart, James Pettitt, Nathan Peiffer‐Smadja, Robert S. Phillips, Jérôme Pierson, Peter Piot, Micheal Piziali, Stéphany Pong, Elena Postnikova, Calvin Proffitt, Alexandre Quach, Sinead Quigley, Nadeeka Randunu, Laura Richert, Priscille Rivière, Cynthia Robinson, Céline Roy, Amy Falk Russell, Philip Sahr, Mohamed Samai, Sibiry Samake, Jen Sandrus, Ibrahim Sanogo, Yeya Sadio Sarro, Serge Sawadogo, Sani Sayadi, Maxime Schvartz, Christine Schwimmer, Fatou Secka, Heema Sharma, Denise Shelley, Bode Shobayo, Sophia Siddiqui, Jakub K. Simon, Shelly Simpson, Billy Muyisa Sivahera, Karen Slater, Mary Smolskis, Elizabeth Smout, Emily Snowden, Anne-Aygline Soutthiphong, Amadou Sow, Samba O Sow, Ydrissa Sow, Michael J. Stirratt, Jeroen N. Stoop, Guna Subramaniam, Léa Surugue, Nathalie Swales, Sienneh Tamba, Chan Tang, Cheick Oumar Tangara, Milagritos D. Tapia, Julius Teahton, Jemee Tegli, Monique Termote, Rodolphe Thiébaut, Greg Thompson, John T. Tierney, Daniel Tindanbil, Abdoulaye Touré, Elvis Towalid, Stacey Traina, Awa Traoré, Tijili Tyee, David Vallée, Renaud Vatrinet, Corine Vincent, Susan Vogel, Cédrick Wallet, Travis K. Warren, Deborah Watson‐Jones, Wade Weaver, Deborah Wentworth, Cecelia Wesseh, Hilary Whitworth, Aurélie Wiedemann, Wouter Willems, Barthalomew Wilson, Jayanthi Wolf, Alie Wurie, Delphine Yamadjako, Marcel Yaradouno, Quiawiah Yarmie, Yazdan Yazdanpanah, Shuǐqìng Yú, Zara Zeggani, Huanying Zhou · 发表于：Clinical Infectious Diseases · 年份：2023 · DOI：10.1093/cid/ciad693 · 被引用次数：18 · 研究领域：Viral Infections and Outbreaks Research、Vaccine Coverage and Hesitancy、Disaster Response and Management

BACKGROUND: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older. METHODS: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR. RESULTS: In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2. CONCLUSIONS: A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses i...