Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19

Detalhes bibliográficos
Autor(a) principal: Sadoff, Jerald
Data de Publicação: 2021
Outros Autores: Gray, Glenda, Vandebosch, An, Cárdenas, Vicky, Shukarev, Georgi, Grinsztejn, Beatriz, Goepfert, Paul A., Truyers, Carla, Fennema, Hein, Spiessens, Bart, Offergeld, Kim, Scheper, Gert, Taylor, Kimberly L., Robb, Merlin L., Treanor, John, Barouch, Dan H., Stoddard, Jeffrey, Ryser, Martin F., Marovich, Mary A., Neuzil, Kathleen M., Corey, Lawrence, Cauwenberghs, Nancy, Tanner, Tamzin, Hardt, Karin, Ruiz-Guiñazú, Javier, Gars, Mathieu Le, Schuitemaker, Hanneke, Hoof, Johan Van, Struyf, Frank, Douoguih, Macaya, ENSEMBLE Study Group
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/50454
Resumo: Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J.R.G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); the National Institute of Allergy and Infectious Diseases, Rockville (K.L.T., M.A.M.), Walter Reed Army Institute of Research, Silver Spring (M.L.R.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); Janssen Research and Development, Raritan, NJ (J. Stoddard); and Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.).
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spelling Sadoff, JeraldGray, GlendaVandebosch, AnCárdenas, VickyShukarev, GeorgiGrinsztejn, BeatrizGoepfert, Paul A.Truyers, CarlaFennema, HeinSpiessens, BartOffergeld, KimScheper, GertTaylor, Kimberly L.Robb, Merlin L.Treanor, JohnBarouch, Dan H.Stoddard, JeffreyRyser, Martin F.Marovich, Mary A.Neuzil, Kathleen M.Corey, LawrenceCauwenberghs, NancyTanner, TamzinHardt, KarinRuiz-Guiñazú, JavierGars, Mathieu LeSchuitemaker, HannekeHoof, Johan VanStruyf, FrankDouoguih, MacayaENSEMBLE Study Group2021-12-15T17:00:15Z2021-12-15T17:00:15Z2021SADOFF, Jerald et al. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. The New England journal of medicine, v. 384, n. 23, p. 2187-2201, 20210028-4793https://www.arca.fiocruz.br/handle/icict/5045410.1056/NEJMoa2101544Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J.R.G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); the National Institute of Allergy and Infectious Diseases, Rockville (K.L.T., M.A.M.), Walter Reed Army Institute of Research, Silver Spring (M.L.R.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); Janssen Research and Development, Raritan, NJ (J. Stoddard); and Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.).Múltiplas - ver em Notas.Background: The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. Methods: In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×1010 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. Results: The per-protocol population included 19,630 SARS-CoV-2-negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe-critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe-critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe-critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe-critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19-related), and 16 in the placebo group (5 were Covid-19-related). Conclusions: A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines.engMassachusetts Medical SocietySafety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleCOVID-19SARS-CoV-2VaccineAd26.COV2.Sinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83099https://www.arca.fiocruz.br/bitstream/icict/50454/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALSafety_Beatriz_Grinsztejn_etal_INI_2021_COVID-19.pdfSafety_Beatriz_Grinsztejn_etal_INI_2021_COVID-19.pdfapplication/pdf660655https://www.arca.fiocruz.br/bitstream/icict/50454/2/Safety_Beatriz_Grinsztejn_etal_INI_2021_COVID-19.pdf9716c6eab76c1d53fa956eb8653d0dc1MD52icict/504542023-02-15 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dc.title.pt_BR.fl_str_mv Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
title Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
spellingShingle Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
Sadoff, Jerald
COVID-19
SARS-CoV-2
Vaccine
Ad26.COV2.S
title_short Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
title_full Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
title_fullStr Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
title_full_unstemmed Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
title_sort Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
author Sadoff, Jerald
author_facet Sadoff, Jerald
Gray, Glenda
Vandebosch, An
Cárdenas, Vicky
Shukarev, Georgi
Grinsztejn, Beatriz
Goepfert, Paul A.
Truyers, Carla
Fennema, Hein
Spiessens, Bart
Offergeld, Kim
Scheper, Gert
Taylor, Kimberly L.
Robb, Merlin L.
Treanor, John
Barouch, Dan H.
Stoddard, Jeffrey
Ryser, Martin F.
Marovich, Mary A.
Neuzil, Kathleen M.
Corey, Lawrence
Cauwenberghs, Nancy
Tanner, Tamzin
Hardt, Karin
Ruiz-Guiñazú, Javier
Gars, Mathieu Le
Schuitemaker, Hanneke
Hoof, Johan Van
Struyf, Frank
Douoguih, Macaya
ENSEMBLE Study Group
author_role author
author2 Gray, Glenda
Vandebosch, An
Cárdenas, Vicky
Shukarev, Georgi
Grinsztejn, Beatriz
Goepfert, Paul A.
Truyers, Carla
Fennema, Hein
Spiessens, Bart
Offergeld, Kim
Scheper, Gert
Taylor, Kimberly L.
Robb, Merlin L.
Treanor, John
Barouch, Dan H.
Stoddard, Jeffrey
Ryser, Martin F.
Marovich, Mary A.
Neuzil, Kathleen M.
Corey, Lawrence
Cauwenberghs, Nancy
Tanner, Tamzin
Hardt, Karin
Ruiz-Guiñazú, Javier
Gars, Mathieu Le
Schuitemaker, Hanneke
Hoof, Johan Van
Struyf, Frank
Douoguih, Macaya
ENSEMBLE Study Group
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Sadoff, Jerald
Gray, Glenda
Vandebosch, An
Cárdenas, Vicky
Shukarev, Georgi
Grinsztejn, Beatriz
Goepfert, Paul A.
Truyers, Carla
Fennema, Hein
Spiessens, Bart
Offergeld, Kim
Scheper, Gert
Taylor, Kimberly L.
Robb, Merlin L.
Treanor, John
Barouch, Dan H.
Stoddard, Jeffrey
Ryser, Martin F.
Marovich, Mary A.
Neuzil, Kathleen M.
Corey, Lawrence
Cauwenberghs, Nancy
Tanner, Tamzin
Hardt, Karin
Ruiz-Guiñazú, Javier
Gars, Mathieu Le
Schuitemaker, Hanneke
Hoof, Johan Van
Struyf, Frank
Douoguih, Macaya
ENSEMBLE Study Group
dc.subject.en.pt_BR.fl_str_mv COVID-19
SARS-CoV-2
Vaccine
Ad26.COV2.S
topic COVID-19
SARS-CoV-2
Vaccine
Ad26.COV2.S
description Beatriz Grinsztejn - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J.R.G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); the National Institute of Allergy and Infectious Diseases, Rockville (K.L.T., M.A.M.), Walter Reed Army Institute of Research, Silver Spring (M.L.R.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); Janssen Research and Development, Raritan, NJ (J. Stoddard); and Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.).
publishDate 2021
dc.date.accessioned.fl_str_mv 2021-12-15T17:00:15Z
dc.date.available.fl_str_mv 2021-12-15T17:00:15Z
dc.date.issued.fl_str_mv 2021
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.citation.fl_str_mv SADOFF, Jerald et al. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. The New England journal of medicine, v. 384, n. 23, p. 2187-2201, 2021
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/50454
dc.identifier.issn.pt_BR.fl_str_mv 0028-4793
dc.identifier.doi.none.fl_str_mv 10.1056/NEJMoa2101544
identifier_str_mv SADOFF, Jerald et al. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. The New England journal of medicine, v. 384, n. 23, p. 2187-2201, 2021
0028-4793
10.1056/NEJMoa2101544
url https://www.arca.fiocruz.br/handle/icict/50454
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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