Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S

Detalhes bibliográficos
Autor(a) principal: Sadoff, Jerald
Data de Publicação: 2022
Outros Autores: 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
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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spelling 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
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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
url https://www.arca.fiocruz.br/handle/icict/52662
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)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
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collection Repositório Institucional da FIOCRUZ (ARCA)
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