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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; Clemens, Sue Ann Costa; Madhi, Shabir A; Weckx, Lily Y; Folegatti, Pedro M; Aley, Parvinder K; Angus, Brian; Baillie, Vicky L; Barnabas, Shaun L; Bhorat, Qasim E; Bibi, Sagida; Briner, Carmen; Cicconi, Paola; Collins, Andrea M; Colin-Jones, Rachel; Cutland, Clare L; Darton, Thomas C; Dheda, Keertan; Duncan, Christopher J A; Emary, Katherine R W; Ewer, Katie J; Fairlie, Lee; Faust, Saul N; Feng, Shuo; Ferreira, Daniela M; Finn, Adam; Goodman, Anna L; Green, Catherine M; Green, Christopher A; Heath, Paul T; Hill, Catherine; Hill, Helen; Hirsch, Ian; Hodgson, Susanne H C; Izu, Alane; Jackson, Susan; Jenkin, Daniel; Joe, Carina C D; Kerridge, Simon; Koen, Anthonet; Kwatra, Gaurav; Lazarus, Rajeka; Lawrie, Alison M; Lelliott, Alice; Libri, Vincenzo; Lillie, Patrick J; Mallory, Raburn; Mendes, Ana V A; Milan, Eveline P; Minassian, Angela M.
  • Voysey M; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Clemens SAC; Institute of Global Health, University of Siena, Siena, Brazil; Department of Paediatrics, University of Oxford, Oxford, UK.
  • Madhi SA; MRC Vaccines and Infectious Diseases Analytics Research Unit, Johannesburg, South Africa.
  • Weckx LY; Department of Pediatrics, Universidade Federal de São Paulo, São Paulo, Brazil.
  • Folegatti PM; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Aley PK; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Angus B; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Baillie VL; Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
  • Barnabas SL; Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch, Cape Town, South Africa.
  • Bhorat QE; Soweto Clinical Trials Centre, Soweto, South Africa.
  • Bibi S; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Briner C; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Cicconi P; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Collins AM; Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
  • Colin-Jones R; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Cutland CL; Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
  • Darton TC; Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK; Department of Infection and Tropical Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
  • Dheda K; Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town, South Africa; Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.
  • Duncan CJA; Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK; Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle University, Newcastle upon Tyne, UK.
  • Emary KRW; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Ewer KJ; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Fairlie L; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Faust SN; NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
  • Feng S; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Ferreira DM; Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
  • Finn A; School of Population Health Sciences, University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Goodman AL; Department of Infection, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK; MRC Clinical Trials Unit, University College London, London, UK.
  • Green CM; Clinical BioManufacturing Facility, University of Oxford, Oxford, UK.
  • Green CA; NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Heath PT; St George's Vaccine Institute, St George's, University of London, London, UK.
  • Hill C; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Hill H; Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
  • Hirsch I; AstraZeneca BioPharmaceuticals, Cambridge, UK.
  • Hodgson SHC; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Izu A; VIDA-Vaccines and Infectious Diseases Analytical Research Unit, Johannesburg, South Africa.
  • Jackson S; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Jenkin D; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Joe CCD; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Kerridge S; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Koen A; VIDA-Vaccines and Infectious Diseases Analytical Research Unit, Johannesburg, South Africa.
  • Kwatra G; Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Lazarus R; Severn Pathology, North Bristol NHS Trust, Bristol, UK.
  • Lawrie AM; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
  • Lelliott A; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
  • Libri V; NIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, London, UK.
  • Lillie PJ; Department of Infection, Hull University Teaching Hospitals NHS Trust, UK.
  • Mallory R; AstraZeneca BioPharmaceuticals, Cambridge, UK.
  • Mendes AVA; Escola Bahiana de Medicina e Saúde Pública, Salvador, Braziland Hospital São Rafael, Salvador, Brazil; Instituto D'Or, Salvador, Brazil.
  • Milan EP; Department of Infectious Diseases, Universidade Federal do Rio Grande do Norte, Natal, Brazil.
  • Minassian AM; Jenner Institute, Nuffield Department of Medicine, University of Oxford, UK.
Lancet ; 397(10269): 99-111, 2021 01 09.
Article in English | MEDLINE | ID: covidwho-1057535
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ABSTRACT

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 (11) 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.

FUNDING:

UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Etiology study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Africa / South America / Brazil / Europa Language: English Journal: Lancet Year: 2021 Document Type: Article Affiliation country: S0140-6736(20)32661-1

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Etiology study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Africa / South America / Brazil / Europa Language: English Journal: Lancet Year: 2021 Document Type: Article Affiliation country: S0140-6736(20)32661-1