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