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, K, Vandebosch, A, Sadoff, J, Le Gars, M, Truyers, C, Lowson, D, Van Dromme, I, Vingerhoets, J, Kamphuis, T, Scheper, G, Ruiz-Guiñazú, J, Faust, SN, Spinner, CD, Schuitemaker, H, Van Hoof, J, Douoguih, M, Struyf, F, Garibaldi, BT, Albertson, TE, Sandrock, C, Lee, JS, Looney, MR, Tapson, VF, Wiysonge, CS, Velarde, LHA, Backenroth, D, Bhushanan, J, Brandenburg, B, Cárdenas, V, Chen, B, Chen, F, Chetty, P, Chu, P-L, Cooper, K, Custers, J, Delanghe, H, Duca, A, Henrick, T, Juraszek, J, Nalpas, C, Peeters, M, Pinheiro, J, Roels, S, Ryser, MF, Salas, J, Santoro Matias, S, Scheys, I, Shetty, P, Shukarev, G, Stoddard, J, Talloen, W, Tran, N, Vaissiere, N, van Son-Palmen, E, Xu, J, Goecker, EA, Greninger, AL, Jerome, KR, Roychoudhury, P, Takuva, SG, Accini Mendoza, JL, Achtyes, E, Ahsan, H, Alhatemi, A, Allen, N, Arribas, JR, Bahrami, G, Bailon, L, Bajwa, A, Baker, J, Baron, M, Benet, S, Berdaï, D, Berger, P, Bertoch, T, Bethune, C, Bevilacqua, S, Biagioni Santos, MS, Binnian, I, Bisnauthsing, K, Boivin, J-M, Bollen, H, Bonnet, S, Borobia, AM, Botelho-Nevers, E, Bright, P, Britten, V, Brown, C, Buadi, A, Buntinx, E, Burgess, L, Bush, L, Capeding, MR, Carr, QO, Carrasco Mas, A, Catala, H, Cathie, K, Caudill, TS, Cereto Castro, F, Chau, K, Chavoustie, S, Chowdhury, M, Chronos, N, Cicconi, P, Cifuentes, L, Cobo, SM, Collins, H, Colton, H, Cuaño, CRG, D'Onofrio, V, Dargan, P, Darton, T, Deane, P, Del Pozo, JL, Derdelinckx, I, Desai, A, Dever, M, Díaz-Pollán, B, DiBuono, M, Doust, M, Duncan, C, Echave-Sustaeta, JM, Eder, F, Ellis, K, Elzi, S, Emmett, S, Engelbrecht, J, Evans, M, Farah, T, Felton, T, Ferreira, JP, Floutier, C, Flume, P, Ford, S, Fragoso, V, Freedman, A, Frentiu, E, Galloway, C, Galtier, F, Garcia Diaz, J, García García, I, Garcia, A, Gardener, Z, Gauteul, P, Geller, S, Gibson, A, Gillet, C, Girerd, N, Girodet, P-O, Gler, MT, Glover, R, Go, HDD, Gokani, K, Gonthier, D, Green, C, Greenberg, R, Griffin, C, Grobbelaar, C, Guancia, A, Hakkarainen, G, Harris, J, Hassman, M, Heimer, D, Hellstrom-Louw, E, Herades, Y, Holroyd, C, Hussen, N, Isidro, MGD, Jackson, Y, Jain, M, João Filho, EC, Johnson, D, Jones, B, Joseph, N, Jumeras, A, Junquera, P, Kellett-Wright, J, Kennedy, P, Kilgore, PE, Kim, K, Kimmel, M, Konis, G, Kutner, M, Lacombe, K, Launay, O, Lazarus, R, Lederman, S, Lefebvre, G, Lennon Collins, K, Leroux-Roels, I, Lim, KWO, Lins, M, Liu, E, Llewelyn, M, Mahomed, A, Maia, BP, Marín-Candon, A, Martínez-Gómez, X, Martinot, JB, Mazzella, A, McCaughan, F, McCormack, L, McGettigan, J, Mehra, P, Mejeur, R, Miller, V, Mills, A, Molto Marhuenda, J, Moodley, P, Mora-Rillo, M, Mothe, B, Mullan, D, Munro, A, Myers, P, Nell, J, Newman Lobato Souza, T, O'Halloran, JA, Ochoa Mazarro, MD, Oliver, A, Onate Gutierrez, JM, Ortega, J, Oshita, M, Otero Romero, S, Overcash, JS, Owens, D, Packham, A, Paiva de Sousa, L, Palfreeman, A, Pallares, CJ, Patel, R, Patel, S, Pelkey, L, Peluso, D, Penciu, F, Pinto, SJ, Pounds, K, Pouzar, J, Pragalos, A, Presti, R, Price, D, Qureshi, E, Ramalho Madruga, JV, Ramesh, M, Rankin, B, Razat, B, Riegel Santos, B, Riesenberg, R, Riffer, E, Roche, S, Rose, K, Rosellini, P, Rossignol, P, Safirstein, B, Salazar, H, Sanchez Vallejo, G, Santhosh, S, Seco-Meseguer, E, Seep, M, Sherry, E, Short, P, Soentjens, P, Solis, J, Soriano Viladomiu, A, Sorli, C, Spangenthal, S, Spence, N, Stephenson, E, Strout, C, Surowitz, R, Taladua, KM, Tellalian, D, Thalamas, C, Thiriphoo, N, Thomas, J, Thomas, N, Trout, G, Urroz, M, Veekmans, B, Veekmans, L, Villalobos, REM, Webster, B, White, A, Williams, G, Williams, H, Wilson, B, Winston, A, Wiselka, M, Zervos, M |
| بيانات النشر: |
Elsevier BV |
| سنة النشر: |
2022 |
| المجموعة: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| 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 |
| اللغة: |
unknown |
| العلاقة: |
Hardt, K, Vandebosch, A, Sadoff, J et al. (285 more authors) (2022) 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. The Lancet Infectious Diseases, 22 (12). pp. 1703-1715. ISSN 1473-3099 |
| الإتاحة: |
https://eprints.whiterose.ac.uk/191241Test/ |
| رقم الانضمام: |
edsbas.8121B604 |
| قاعدة البيانات: |
BASE |
