Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Detalhes bibliográficos
Autor(a) principal: Voysey, Merryn
Data de Publicação: 2021
Outros Autores: Sprinz, Eduardo, Stein, Ricardo, Cunha, Debora Rosilei Miquini de Freitas, Silva, Larissa Pozzebon da, Santos, Thainá Garbino dos, Dias, Ana Luiza Perez Olive, Pinheiro, Jéssica Morgana Gediel, Sorio, Guilherme Geraldo Lovato, Vieira, Taiane Alves, Zambrano, Marina Bauer, Zimmer, Rafael Leal, Arns, Beatriz, Oxford COVID Vaccine Trial Group
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFRGS
Texto Completo: http://hdl.handle.net/10183/230720
Resumo: Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.
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spelling Voysey, MerrynSprinz, EduardoStein, RicardoCunha, Debora Rosilei Miquini de FreitasSilva, Larissa Pozzebon daSantos, Thainá Garbino dosDias, Ana Luiza Perez OlivePinheiro, Jéssica Morgana GedielSorio, Guilherme Geraldo LovatoVieira, Taiane AlvesZambrano, Marina BauerZimmer, Rafael LealArns, BeatrizOxford COVID Vaccine Trial Group2021-10-14T04:30:53Z20210140-6736http://hdl.handle.net/10183/230720001131498Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.application/pdfengThe Lancet. London. Vol. 397, no. 10269 (2021), p. 881-891.Infecções por coronavirusCOVID-19SARS-CoV-2VacinasSafety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UKEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001131498.pdf.txt001131498.pdf.txtExtracted Texttext/plain79753http://www.lume.ufrgs.br/bitstream/10183/230720/2/001131498.pdf.txtf2c841696694d2f84099e92542889873MD52ORIGINAL001131498.pdfTexto completo (inglês)application/pdf377590http://www.lume.ufrgs.br/bitstream/10183/230720/1/001131498.pdfe1fd24227e2e9dd3251a7777d8003978MD5110183/2307202021-11-20 06:05:38.880603oai:www.lume.ufrgs.br:10183/230720Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2021-11-20T08:05:38Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false
dc.title.pt_BR.fl_str_mv Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
title Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
spellingShingle Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
Voysey, Merryn
Infecções por coronavirus
COVID-19
SARS-CoV-2
Vacinas
title_short Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
title_full Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
title_fullStr Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
title_full_unstemmed Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
title_sort Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2 : an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
author Voysey, Merryn
author_facet Voysey, Merryn
Sprinz, Eduardo
Stein, Ricardo
Cunha, Debora Rosilei Miquini de Freitas
Silva, Larissa Pozzebon da
Santos, Thainá Garbino dos
Dias, Ana Luiza Perez Olive
Pinheiro, Jéssica Morgana Gediel
Sorio, Guilherme Geraldo Lovato
Vieira, Taiane Alves
Zambrano, Marina Bauer
Zimmer, Rafael Leal
Arns, Beatriz
Oxford COVID Vaccine Trial Group
author_role author
author2 Sprinz, Eduardo
Stein, Ricardo
Cunha, Debora Rosilei Miquini de Freitas
Silva, Larissa Pozzebon da
Santos, Thainá Garbino dos
Dias, Ana Luiza Perez Olive
Pinheiro, Jéssica Morgana Gediel
Sorio, Guilherme Geraldo Lovato
Vieira, Taiane Alves
Zambrano, Marina Bauer
Zimmer, Rafael Leal
Arns, Beatriz
Oxford COVID Vaccine Trial Group
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Voysey, Merryn
Sprinz, Eduardo
Stein, Ricardo
Cunha, Debora Rosilei Miquini de Freitas
Silva, Larissa Pozzebon da
Santos, Thainá Garbino dos
Dias, Ana Luiza Perez Olive
Pinheiro, Jéssica Morgana Gediel
Sorio, Guilherme Geraldo Lovato
Vieira, Taiane Alves
Zambrano, Marina Bauer
Zimmer, Rafael Leal
Arns, Beatriz
Oxford COVID Vaccine Trial Group
dc.subject.por.fl_str_mv Infecções por coronavirus
COVID-19
SARS-CoV-2
Vacinas
topic Infecções por coronavirus
COVID-19
SARS-CoV-2
Vacinas
description Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.
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dc.relation.ispartof.pt_BR.fl_str_mv The Lancet. London. Vol. 397, no. 10269 (2021), p. 881-891.
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