التفاصيل البيبلوغرافية
| العنوان: |
Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2) : results of a randomised, double-blind, placebo-controlled, phase 3 trial |
| المؤلفون: |
Hardt, Karin, Vandebosch, An, Sadoff, Jerald, Le Gars, Mathieu, Truyers, Carla, Lowson, David, Van Dromme, Ilse, Vingerhoets, Johan, Kamphuis, Tobias, Scheper, Gert, Ruiz-Guiñazú, Javier, Faust, Saul N, Spinner, Christoph D, Schuitemaker, Hanneke, Van Hoof, Johan, Douoguih, Macaya, Struyf, Frank, Garibaldi, Brian T., Albertson, Timothy E., Sandrock, Christian, Lee, Janet S., Looney, Mark R., Tapson, Victor F., Wiysonge, Charles Shey, Velarde, Luis Humberto Anaya, Backenroth, Daniel, Bhushanan, Jisha, Brandenburg, Börries, Cárdenas, Vicky, Chen, Bohang, Chen, Fei, Chetty, Polan, Chu, Pei-Ling, Cooper, Kimberly, Custers, Jerome, Delanghe, Hilde, Duca, Anna, Henrick, Tracy, Juraszek, Jarek, Nalpas, Catherine, Peeters, Monika, Pinheiro, Jose, Roels, Sanne, Ryser, Martin F., Salas, Jose, Santoro Matias, Samantha, Scheys, Ilse, Shetty, Pallavi, Shukarev, Georgi, Stoddard, Jeffrey, Talloen, Willem, Tran, NamPhuong, Vaissiere, Nathalie, van Son-Palmen, Elisabeth, Xu, Jiajun, Goecker, Erin A., Greninger, Alexander L., Jerome, Keith R., Roychoudhury, Pavitra, Takuva, Simbarashe G., Accini Mendoza, Jose Luis, Achtyes, Eric, Ahsan, Habibul, Alhatemi, Azhar, Allen, Nancy, Arribas, Jose R., Bahrami, Ghazaleh, Bailon, Lucia, Bajwa, Ali, Baker, Jonathan, Baron, Mira, Benet, Susana, Berdaï, Driss, Berger, Patrick, Bertoch, Todd, Bethune, Claire, Bevilacqua, Sybille, Biagioni Santos, Maria Silvia, Binnian, Ian, Bisnauthsing, Karen, Boivin, Jean-Marc, Bollen, Hilde, Bonnet, Sandrine, Borobia, Alberto M., Botelho-Nevers, Elisabeth, Bright, Phil, Britten, Vianne, Brown, Claire, Buadi, Amanda, Buntinx, Erik, Burgess, Lesley, Bush, Larry, Capeding, Maria Rosario, Carr, Quito Osuna, Carrasco Mas, Amparo, Catala, Hélène, Cathie, Katrina, Caudill, T. Shawn, Cereto Castro, Fernando, Chau, Kénora, Chavoustie, Steven, Chowdhury, Marie, Chronos, Nicolas, Cicconi, Paola, Cifuentes, Liliana, Cobo, Sara Maria, Collins, Helen, Colton, Hayley, Cuaño, Carlos Rolando G., D'Onofrio, Valentino, Dargan, Paul, Darton, Thomas, Deane, Peter, Del Pozo, Jose Luis, Derdelinckx, Inge, Desai, Amisha, Dever, Michael, Díaz-Pollán, Beatriz, DiBuono, Mark, Doust, Matthew, Duncan, Christopher, Echave-Sustaeta, Jose Maria, Eder, Frank, Ellis, Kimberly, Elzi, Stanton, Emmett, Stevan, Engelbrecht, Johannes, Evans, Mim, Farah, Theo, Felton, Timothy, Ferreira, João Pedro, Floutier, Catherine, Flume, Patrick, Ford, Stacy, Fragoso, Veronica, Freedman, Andrew, Frentiu, Emilia, Galloway, Christopher, Galtier, Florence, Garcia Diaz, Julia, García García, Irene, Garcia, Alcaide, Gardener, Zoe, Gauteul, Pascale, Geller, Steven, Gibson, Andrew, Gillet, Claudia, Girerd, Nicolas, Girodet, Pierre-Olivier, Gler, Maria Tarcela, Glover, Richard, Go, Herschel Don D., Gokani, Karishma, Gonthier, Damien, Green, Christopher, Greenberg, Richard, Griffin, Carl, Grobbelaar, Coert, Guancia, Adonis, Hakkarainen, Gloria, Harris, James, Hassman, Michael, Heimer, Deirdre, Hellstrom-Louw, Elizabeth, Herades, Yoan, Holroyd, Christopher, Hussen, Nazreen, Isidro, Marie Grace Dawn, Jackson, Yvonne, Jain, Manish, João Filho, Esaú Custódio, Johnson, Daniel, Jones, Ben, Joseph, Natasha, Jumeras, Analyn, Junquera, Patricia, Kellett-Wright, Johanna, Kennedy, Patrick, Kilgore, Paul E., Kim, Kenneth, Kimmel, Murray, Konis, George, Kutner, Mark, Lacombe, Karine, Launay, Odile, Lazarus, Rajeka, Lederman, Samuel, Lefebvre, Gigi, Lennon Collins, Katrina, Leroux-Roels, Isabel, Lim, Kenneth Wilson O., Lins, Muriel, Liu, Edward, Llewelyn, Martin, Mahomed, Akbar, Maia, Bernardo Porto, Marín-Candon, Alícia, Martínez-Gómez, Xavier, Martinot, Jean Benoit, Mazzella, Andrea, McCaughan, Frank, McCormack, Louise, McGettigan, John, Mehra, Purvi, Mejeur, Rhonda, Miller, Vicki, Mills, Anthony, Molto Marhuenda, Jose, Moodley, Prebashan, Mora-Rillo, Marta, Mothe, Beatriz, Mullan, Daniel, Munro, Alasdair, Myers, Paul, Nell, Jeremy, Newman Lobato Souza, Tamara, O'Halloran, Jane A., Ochoa Mazarro, Maria Dolores, Oliver, Abigail, Onate Gutierrez, Jose Millan, Ortega, Jessica, Oshita, Masaru, Otero Romero, Susana, Overcash, Jeffrey Scott, Owens, Daniel, Packham, Alice, Pacurar, Mihaela, Paiva de Sousa, Leonardo, Palfreeman, Adrian, Pallares, Christian José, Patel, Rahul, Patel, Suchet, Pelkey, Leslie, Peluso, Denise, Penciu, Florentina, Pinto, S. Jerry, Pounds, Kevin, Pouzar, Joe, Pragalos, Antoinette, Presti, Rachel, Price, David, Qureshi, Ehsaan, Ramalho Madruga, José Valdez, Ramesh, Mayur, Rankin, Bruce, Razat, Béatrice, Riegel Santos, Breno, Riesenberg, Robert, Riffer, Ernie, Roche, Siobhan, Rose, Katie, Rosellini, Pietro, Rossignol, Patrick, Safirstein, Beth, Salazar, Hernan, Sanchez Vallejo, Gregorio, Santhosh, Smrithi, Seco-Meseguer, Enrique, Seep, Michael, Sherry, Emma, Short, Philip, Soentjens, Patrick, Solis, Joel, Soriano Viladomiu, Alejandro, Sorli, Caroline, Spangenthal, Selwyn, Spence, Niamh, Stephenson, Elaine, Strout, Cynthia, Surowitz, Ronald, Taladua, Kristy Michelle, Tellalian, David, Thalamas, Claire, Thiriphoo, Nang, Thomas, Judith, Thomas, Nicholas, Trout, Guillermo, Urroz, Mikel, Veekmans, Bernard, Veekmans, Laurent, Villalobos, Ralph Elvi M., Warren, Sarah, Webster, Brian, White, Alexander, Williams, Gail, Williams, Hayes, Wilson, Barbara, Winston, Alan, Wiselka, Martin, Zervos, Marcus, Study Grp, ENSEMBLE2 |
| المصدر: |
LANCET INFECTIOUS DISEASES ; ISSN: 1473-3099 ; ISSN: 1474-4457 |
| بيانات النشر: |
Elsevier BV |
| سنة النشر: |
2022 |
| المجموعة: |
Ghent University Academic Bibliography |
| مصطلحات موضوعية: |
Medicine and Health Sciences, Infectious Diseases |
| الوصف: |
Background Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and immunogenicity of the Ad26.COV2.S vaccine (Janssen) as primary vaccination plus a booster dose. Methods ENSEMBLE2 is a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines. Adults aged at least 18 years without previous COVID-19 vaccination at public and private medical practices and hospitals in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK, and the USA were randomly assigned 1:1 via a computer algorithm to receive intramuscularly administered Ad26.COV2.S as a primary dose plus a booster dose at 2 months or two placebo injections 2 months apart. The primary endpoint was vaccine efficacy against the first occurrence of molecularly confirmed moderate to severe-critical COVID-19 with onset at least 14 days after booster vaccination, which was assessed in participants who received two doses of vaccine or placebo, were negative for SARS-CoV-2 by PCR at baseline and on serology at baseline and day 71, had no major protocol deviations, and were at risk of COVID-19 (ie, had no PCR-positive result or discontinued the study before day 71). Safety was assessed in all participants; reactogenicity, in terms of solicited local and systemic adverse events, was assessed as a secondary endpoint in a safety subset (approximately 6000 randomly selected participants). The trial is registered with ClinicalTrials.gov, NCT04614948, and is ongoing. Findings Enrolment began on Nov 16, 2020, and the primary analysis data cutoff was June 25, 2021. From 34 571 participants screened, the double-blind phase enrolled 31 300 participants, 14 492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11 639 of whom were ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| العلاقة: |
https://biblio.ugent.be/publication/01GWJCY9FEX413P283JP2D62KATest; http://hdl.handle.net/1854/LU-01GWJCY9FEX413P283JP2D62KATest; http://dx.doi.org/10.1016/s1473-3099Test(22)00506-0; https://biblio.ugent.be/publication/01GWJCY9FEX413P283JP2D62KA/file/01GWJD4AFNVYGGVT7JYW6R5W5XTest |
| DOI: |
10.1016/s1473-3099(22)00506-0 |
| الإتاحة: |
https://doi.org/10.1016/s1473-3099Test(22)00506-0
https://biblio.ugent.be/publication/01GWJCY9FEX413P283JP2D62KATest
http://hdl.handle.net/1854/LU-01GWJCY9FEX413P283JP2D62KATest
https://biblio.ugent.be/publication/01GWJCY9FEX413P283JP2D62KA/file/01GWJD4AFNVYGGVT7JYW6R5W5XTest |
| حقوق: |
No license (in copyright) ; info:eu-repo/semantics/restrictedAccess |
| رقم الانضمام: |
edsbas.F622B1FE |
| قاعدة البيانات: |
BASE |
