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2023
article
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
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, Jamila Aboulhab, Michelle Aguirre-MacKenzie, 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, Michael Belson, Marion Bererd, Teedoh Beyslow, Jeanne Billioux, Shere Billouin-Frazier, Blandine Binachon, 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, Djélikan Siaka Conde, Katherine Cone, 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, 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, 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, Swati Gupta, Fadima Cheick Haidara, Emma Hancox, Jean-Christophe Hébert, Jenny Hendriks, Patricia Hensley, Elisabeth Higgs, Trudi Hilton, H. Preston Holley, Marie L. Hoover, Melissa E. Hughes, Skip Irvine, David Ishola, Yvonne Jato, Madison Joe, Melvin Johnson, Aboubacar Kaba, Jonathan C. Kagan, Michael Kamara, Myriam Kanté, Judith Katoudi, Cheick Mohamed Keita, Seykou Keita, Stephen B. Kennedy, Babajide Keshinro, Hassan Kiawu, 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, Frederic Lemarcis, Yves Lévy, Claire Lévy‐Marchal, Maarten Leyssen, Janie Liang, Mameni Linga, Ken Liu, Julia Lysander, Ibrah Mahamadou, Marvington Mambiah, Daniela Manno, Jonathan Marchand, Lindsay Marron, Moses Massaquoi, Laure Masson, Charly Matard, Steven Mazur, 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, Amy Falk Russell, Philip Sahr, Sibiry Samake, Jen Sandrus, Ibrahim Sanogo, Yeya Sadio Sarro, Serge Sawadogo, Sani Sayadi, Maxime Schvartz, Christine Schwimmer, Heema Sharma, Denise Shelley, Bode Shobayo, Sophia Siddiqui, Shelly Simpson, Billy Muyisa Sivahera, Karen Slater, Mary Smolskis, Elizabeth Smout, Emily Snowden, Anne-Aygline Soutthiphong, Amadou 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, 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, 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
18Citations signalées — pas une note de qualité
14Institutions déclarées
7Pays d’affiliation déclarés
Résumé fourni par la source
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 induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 15/11/2023
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude et ne compte pas comme une seconde source scientifique indépendante.
Institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Sujets associés
Viral Infections and Outbreaks ResearchVaccine Coverage and HesitancyDisaster Response and Management