Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
Texto Completo: | https://www.arca.fiocruz.br/handle/icict/52662 |
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, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., 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.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the 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.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard). |
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Sadoff, JeraldGray, GlendaVandebosch, AnCárdenas, VickyShukarev, GeorgiGrinsztejn, BeatrizGoepfert, Paul A.Truyers, CarlaDromme, Ilse VanSpiessens, BartVingerhoets, JohanCusters, JeromeScheper, GertRobb, Merlin L.Treanor, JohnRyser, Martin F.Barouch, Dan H.Swann, EdithMarovich, Mary A.Neuzil, Kathleen M.Corey, LawrenceStoddard, JeffreyHardt, KarinRuiz-Guiñazú, JavierLe Gars, MathieuSchuitemaker, HannekeHoof, Johan VanStruyf, FrankDouoguih, MacayaENSEMBLE Study Group2022-05-13T14:56:31Z2022-05-13T14:56:31Z2022SADOFF, Jerald et al. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. The New England journal of medicine, v. 386, n. 9, p. 847-860, 20221533-4406https://www.arca.fiocruz.br/handle/icict/5266210.1056/NEJMoa2117608Beatriz 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, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., 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.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the 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.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard).Múltiplas - Ver em Notas.Background: The Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis. Methods: We conducted the final analysis in the double-blind phase of our multinational, randomized, placebo-controlled trial, in which adults were assigned in a 1:1 ratio to receive single-dose Ad26.COV2.S (5×1010 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration in the per-protocol population. Safety and key secondary and exploratory end points were also assessed. Results: Median follow-up in this analysis was 4 months; 8940 participants had at least 6 months of follow-up. In the per-protocol population (39,185 participants), vaccine efficacy against moderate to severe-critical Covid-19 at least 14 days after administration was 56.3% (95% confidence interval [CI], 51.3 to 60.8; 484 cases in the vaccine group vs. 1067 in the placebo group); at least 28 days after administration, vaccine efficacy was 52.9% (95% CI, 47.1 to 58.1; 433 cases in the vaccine group vs. 883 in the placebo group). Efficacy in the United States, primarily against the reference strain (B.1.D614G) and the B.1.1.7 (alpha) variant, was 69.7% (95% CI, 60.7 to 76.9); efficacy was reduced elsewhere against the P.1 (gamma), C.37 (lambda), and B.1.621 (mu) variants. Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to medical intervention (including hospitalization), and 82.8% (95% CI, 40.5 to 96.8) against Covid-19-related death, with protection lasting 6 months or longer. Efficacy against any severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was 41.7% (95% CI, 36.3 to 46.7). Ad26.COV2.S was associated with mainly mild-to-moderate adverse events, and no new safety concerns were identified. Conclusions: A single dose of Ad26.COV2.S provided 52.9% protection against moderate to severe-critical Covid-19. Protection varied according to variant; higher protection was observed against severe Covid-19, medical intervention, and death than against other end points and lasted for 6 months or longeengMassachusetts Medical SocietyFinal Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.Sinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleCOVID-19SARS-CoV-2VaccineAd26.COV2.SEfficacySafetyinfo: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/52662/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALFinal_Beatriz_Grinsztejn_etal_INI_2022_COVID-19.pdfFinal_Beatriz_Grinsztejn_etal_INI_2022_COVID-19.pdfapplication/pdf691223https://www.arca.fiocruz.br/bitstream/icict/52662/2/Final_Beatriz_Grinsztejn_etal_INI_2022_COVID-19.pdf9d2565599a62caa1dff96c53a725a5a7MD52icict/526622022-05-13 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dc.title.pt_BR.fl_str_mv |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S |
title |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S |
spellingShingle |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S Sadoff, Jerald COVID-19 SARS-CoV-2 Vaccine Ad26.COV2.S Efficacy Safety |
title_short |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S |
title_full |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S |
title_fullStr |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S |
title_full_unstemmed |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S |
title_sort |
Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S |
author |
Sadoff, Jerald |
author_facet |
Sadoff, Jerald Gray, Glenda Vandebosch, An Cárdenas, Vicky Shukarev, Georgi Grinsztejn, Beatriz Goepfert, Paul A. Truyers, Carla Dromme, Ilse Van Spiessens, Bart Vingerhoets, Johan Custers, Jerome Scheper, Gert Robb, Merlin L. Treanor, John Ryser, Martin F. Barouch, Dan H. Swann, Edith Marovich, Mary A. Neuzil, Kathleen M. Corey, Lawrence Stoddard, Jeffrey Hardt, Karin Ruiz-Guiñazú, Javier Le Gars, Mathieu 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 Dromme, Ilse Van Spiessens, Bart Vingerhoets, Johan Custers, Jerome Scheper, Gert Robb, Merlin L. Treanor, John Ryser, Martin F. Barouch, Dan H. Swann, Edith Marovich, Mary A. Neuzil, Kathleen M. Corey, Lawrence Stoddard, Jeffrey Hardt, Karin Ruiz-Guiñazú, Javier Le Gars, Mathieu 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 |
dc.contributor.author.fl_str_mv |
Sadoff, Jerald Gray, Glenda Vandebosch, An Cárdenas, Vicky Shukarev, Georgi Grinsztejn, Beatriz Goepfert, Paul A. Truyers, Carla Dromme, Ilse Van Spiessens, Bart Vingerhoets, Johan Custers, Jerome Scheper, Gert Robb, Merlin L. Treanor, John Ryser, Martin F. Barouch, Dan H. Swann, Edith Marovich, Mary A. Neuzil, Kathleen M. Corey, Lawrence Stoddard, Jeffrey Hardt, Karin Ruiz-Guiñazú, Javier Le Gars, Mathieu 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 Efficacy Safety |
topic |
COVID-19 SARS-CoV-2 Vaccine Ad26.COV2.S Efficacy Safety |
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, J.C., G. Scheper, M.L.G., H.S., J.V.H., M.D.); the South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., I.V.D., B.S., J.V., M.F.R., 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.); Walter Reed Army Institute of Research, Silver Spring (M.L.R.), the National Institute of Allergy and Infectious Diseases, Rockville (E.S., M.A.M.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; the 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.); the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.); and Janssen Research and Development, Raritan, NJ (J. Stoddard). |
publishDate |
2022 |
dc.date.accessioned.fl_str_mv |
2022-05-13T14:56:31Z |
dc.date.available.fl_str_mv |
2022-05-13T14:56:31Z |
dc.date.issued.fl_str_mv |
2022 |
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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article |
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publishedVersion |
dc.identifier.citation.fl_str_mv |
SADOFF, Jerald et al. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. The New England journal of medicine, v. 386, n. 9, p. 847-860, 2022 |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/52662 |
dc.identifier.issn.pt_BR.fl_str_mv |
1533-4406 |
dc.identifier.doi.none.fl_str_mv |
10.1056/NEJMoa2117608 |
identifier_str_mv |
SADOFF, Jerald et al. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. The New England journal of medicine, v. 386, n. 9, p. 847-860, 2022 1533-4406 10.1056/NEJMoa2117608 |
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https://www.arca.fiocruz.br/handle/icict/52662 |
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eng |
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eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
dc.publisher.none.fl_str_mv |
Massachusetts Medical Society |
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Massachusetts Medical Society |
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