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Randomized Controlled Trial
。2021 Jan9；397（10269）：99-111。
doi:10.1016/S0140-6736（20）32661-1。 Epub2020Dec8。

Safety and efficacy of the ChAdOx1nCoV-19vaccine（AZD1222）against SARS-CoV-2:an interim analysis of four randomised controlled trials in Brazil，South Africa，and the UK

中间Voysey 1个单击功能区上Sue Ann Costa Clemens 2单击功能区上Shabir A Madhi 3单击功能区上Lily Y Weckx 4个单击功能区上Pedro M Folegatti 5单击功能区上Parvinder K Aley 1个单击功能区上Brian Angus 5单击功能区上Vicky L Baillie 6个单击功能区上Shaun L Barnabas 7单击功能区上Qasim E Bhorat 8个单击功能区上Sagida Bibi 1个单击功能区上Carmen Briner 9单击功能区上Paola Cicconi 5单击功能区上Andrea M Collins 10单击功能区上Rachel Colin-Jones 1个单击功能区上Clare L Cutland 6个单击功能区上Thomas C Darton 11单击功能区上Keertan Dheda 12单击功能区上Christopher J A Duncan 13单击功能区上Katherine R W Emary 1个单击功能区上Katie J Ewer 5单击功能区上Lee Fairlie 14单击功能区上Saul N Faust 15单击功能区上外壳，外壳 1个单击功能区上Daniela M Ferreira 10单击功能区上Adam Finn 16单击功能区上Anna L Goodman 第十七节：单击功能区上Catherine M Green 18单击功能区上Christopher A Green 19单击功能区上Paul T Heath 20单击功能区上机座，机座 14单击功能区上Helen Hill 10单击功能区上Ian Hirsch 21单击功能区上Sunne HC Hodgson 5单击功能区上Alane Izu 22单击功能区上Susan Jackson 5单击功能区上Daniel Jenkin 5单击功能区上Carina C D Joe 5单击功能区上Simon Kerridge 1个单击功能区上Anthonet Koen 22单击功能区上Gaurav Kwatra 14单击功能区上Rajeka Lazarus 23单击功能区上Alison M Lawrie 5单击功能区上Alice Lelliott 1个单击功能区上Vincenzo Libri 第二十四节：单击功能区上Patrick J Lillie 25单击功能区上拉伯恩工厂 21单击功能区上Ana V A Mendes 26单击功能区上Eveline P Milan 27单击功能区上Angela M Minassian 5单击功能区上Alastair McGregor 28单击功能区上Hazel Morrison 5单击功能区上Yama F Mujadidi 1个单击功能区上Anusha Nana 9单击功能区上Peter J O’Reilly 1个单击功能区上Sherman D Padayachee 29单击功能区上Ana Pittella 30单击功能区上Emma Plested 1个单击功能区上Katrina M Pollock 31单击功能区上Maheshi N Ramasamy 1个单击功能区上Sarah Rhead 1个单击功能区上Alexandre V Schwarzbold 32单击功能区上Nisha Singh 1个单击功能区上Andrew Smith 33单击功能区上Rinn Song 34单击功能区上Matthew D Snape 1个单击功能区上Eduardo Sprinz 35单击功能区上Rebecca K Sutherland 36单击功能区上Richard Tarrant 18单击功能区上Emma C Thomson 37单击功能区上Estée Török 38单击功能区上Mark Toshner 39单击功能区上David PJ Turner 40单击功能区上Johan Vekemans 21单击功能区上Tonya L Villafana 21单击功能区上Marion E E Watson 5单击功能区上Christopher J Williams 41单击功能区上Alexander D Douglas 5单击功能区上Adrian V S Hill 5单击功能区上Teresa Lambe 5单击功能区上Sarah C Gilbert 5单击功能区上Andrew J Pollard 42打开； Oxford COVID Vaccine Trial Group
Collaborators，疲劳，疲劳
Randomized Controlled Trial

Safety and efficacy of the ChAdOx1nCoV-19vaccine（AZD1222）against SARS-CoV-2:an interim analysis of four randomised controlled trials in Brazil，South Africa，and the UK

中间Voyseyet al。 Lancet。 。

Erratum in

  • Department of Error。
    未列出 未列出 Lancet.2021Jan9；397（10269）：98。doi:10.1016/S0140-6736（20）32720-3。 Lancet.2021。 PMID:3342262 Free PMC article。 No abstract available。

Abstract

背景：A safe and efficicacious vaccine against severe acute respiratory syndrome coronavirus2（SARS-Cov-2），if deployed with high coverage，could contribute to the control of the COVID-19pandemic.We evaluated the safety and efficacy of the ChAdOx1nCoV-19vaccine in a pooled interim analysis of four trials。

方法：This analysis includes data from four ongoing blinded，randomised，controlled trials done across the UK，Brazil，and South Africa.Participats aged18years and older were randomly assigned（1:1）to ChAdOx1nCoV-19vaccine or control（meningococcal group A，C，W，and Y conjugate vaccine or saline）.Participants in the ChAdOx1nCoV-19group received two doses containing5×1010viral particles（standard dose；SD/SD cohort）；asubset 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-19in seronegative participants with anuceric acid amplification test-positive swab more than14 days after a second dose of vaccine.Participants were analysed according to treatment received，with data cutoff on Nov4，2020。Vaccine efficacy was calculated as1-relative risk derived from arobust Poisson regression model adjusted forage.Studies are registered at ISRCTN89951424and ClinicalTrials.gov，NCT04324606单击功能区上，NCT04400838，andNCT0444674。

查找：Between April23and Nov420023848participants were enrolled and 11636participants（7548in the UK，4088in Brazil）were included in the interim primary efficacy analysis。In participants who received two standard doses，vaccine efficacy was62.1%（95%CI41.0-75.7；27[0.6%]of 4440 in the ChAdOx1nCoV-19group vs71[1.6%]of 4455 in the control group）and in participants who received a low dose followed by a standard dose，efficacy was90.0%（67.4-97.0；three[0.2%]of1367 vs30[2.2%]of1374；pinteraction=0.010。70.4%（95.8%CI54.8-80.6；30[0.5%]of5807vs101[1.7%]of5829）。From21 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 were74341 person-months of safety follow-up（median3·4months，IQR1·3-4·8：175 severe adverse events occurred in 168 participants，84 events in the ChAdOx1nCoV-19group and 91 in the control group.Three events were classified as possibly related to avaccine:one in the ChAdOx1nCoV-19group，one in the control group，and in in a partipant hogroup maid。

Interpretation：ChAdOx1nCoV-19has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19in this interim analysis of ongoing clinical trials。

Funding：UK Research and Innovation，National Institutes for Health Research（NIHR），Coalition for Epidemic Preperedness Innovations，Bill&Melinda Gates Foundation，Lemann Foundation，Rede D'Or，Brava and Telles Foundation，NIHR Oxford Biomedical Research Centre，Thames Valley and South Midlands NIHR Clinical Research Network，and AstraZeneca。

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Figures

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Kaplan-Meier cumulative incidence of primary symptomatic，NAAT-positive COVID-19Cumulative incidence of symptomatic COVID-19after two doses（left）or after first standard dose in participants receiving only standard-dose vaccines（right）。Grey shaded areas show the exclusion period after each dose in which cases were excluded from the analysis.Blue and red shaded areas show95%CIs.LD/SD=low-dose prime plus standard-dose boost.MenACWY=meningocococcal group A，C，W，and Y conjugate vaccine.NAAT=nucleic acid ampifififigurd dose vaccines given。
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