부산대학교 도서관

Summary Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4--12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials--one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)--and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5,x,10.sup.10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2*2,x,10.sup.10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever [greater than or equal to]37*8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24,422 participants were recruited and vaccinated across the four studies, of whom 17,178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more than 14 days after the second dose. Overall vaccine efficacy more than 14 days after the second dose was 66*7% (95% CI 57*4--74*0), with 84 (1*0%) cases in the 8597 participants in the ChAdOx1 nCoV-19 group and 248 (2*9%) in the 8581 participants in the control group. There were no hospital admissions for COVID-19 in the ChAdOx1 nCoV-19 group after the initial 21-day exclusion period, and 15 in the control group. 108 (0*9%) of 12,282 participants in the ChAdOx1 nCoV-19 group and 127 (1*1%) of 11,962 participants in the control group had serious adverse events. There were seven deaths considered unrelated to vaccination (two in the ChAdOx1 nCov-19 group and five in the control group), including one COVID-19-related death in one participant in the control group. Exploratory analyses showed that vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 after vaccination was 76*0% (59*3--85*9). Our modelling analysis indicated that protection did not wane during this initial 3-month period. Similarly, antibody levels were maintained during this period with minimal waning by day 90 (geometric mean ratio [GMR] 0*66 [95% CI 0*59--0*74]). In the participants who received two standard doses, after the second dose, efficacy was higher in those with a longer prime-boost interval (vaccine efficacy 81*3% [95% CI 60*3--91*2] at [greater than or equal to]12 weeks) than in those with a short interval (vaccine efficacy 55*1% [33*0--69*9] at Interpretation The results of this primary analysis of two doses of ChAdOx1 nCoV-19 were consistent with those seen in the interim analysis of the trials and confirm that the vaccine is efficacious, with results varying by dose interval in exploratory analyses. A 3-month dose interval might have advantages over a programme with a short dose interval for roll-out of a pandemic vaccine to protect the largest number of individuals in the population as early as possible when supplies are scarce, while also improving protection after receiving a second dose. Funding UK Research and Innovation, National Institutes of Health Research (NIHR), The Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca. Author Affiliation: (a) Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK (b) Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK (c) Institute of Global Health, University of Siena, Siena, Italy (d) Department of Paediatrics, University of Oxford, Oxford, UK (e) Clinical BioManufacturing Facility, University of Oxford, Oxford, UK (f) South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa (g) Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit, University of the Witwatersrand, Johannesburg, South Africa (h) Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa (i) Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa (j) Department of Pediatrics, Universidade Federal de São Paulo, São Paulo, Brazil (k) AstraZeneca BioPharmaceuticals, Cambridge, UK (l) Family Centre for Research with Ubuntu, Department of Paediatrics, University of Stellenbosch, Cape Town, South Africa (m) Soweto Clinical Trials Centre, Soweto, South Africa (n) Department of Clinical Sciences, Liverpool School of Tropical Medicine and Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK (o) Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK (p) Department of Infection and Tropical Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK (q) Escola Bahiana de Medicina e Saúde Pública, Salvador, Braziland Hospital São Rafael, Salvador, Brazil (r) Instituto D'Or, Salvador, Brazil (s) Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town, Cape Town, South Africa (t) Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK (u) Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK (v) Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle University, Newcastle upon Tyne, UK (w) NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, University of Southampton, Southampton, UK (x) Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK (y) School of Population Health Sciences, University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust, UK (z) Department of Infection, Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK (aa) MRC Clinical Trials Unit, University College London, London, UK (ab) NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK (ac) St George's Vaccine Institute, St George's, University of London, London, UK (ad) Severn Pathology, North Bristol NHS Trust, Bristol, UK (ae) NIHR UCLH Clinical Research Facility and NIHR UCLH Biomedical Research Centre, London, UK (af) Department of Infection, Hull University Teaching Hospitals NHS Trust, Hull, UK (ag) London Northwest University Healthcare, Harrow, UK (ah) Setshaba Research Centre, Pretoria, South Africa (ai) Universidade Federal do Rio Grande do Norte, Natal, Brazil (aj) Hospital Quinta D'Or, Rede D'Or, Rio De Janeiro, Brazil (ak) NIHR Imperial Clinical Research Facility and NIHR Imperial Biomedical Research Centre, London, UK (al) College of Medical, Veterinary & Life Sciences, Glasgow Dental Hospital & School, University of Glasgow, Glasgow, UK (am) Infectious Diseases Service, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil (an) Clinical Research Unit, Department of Clinical Medicine, Universidade Federal de Santa Maria, Santa Maria, Brazil (ao) Clinical Infection Research Group, Regional Infectious Diseases Unit, Western General Hospital, Edinburgh, UK (ap) MRC-University of Glasgow Centre for Virus Research & Department of Infectious Diseases, Queen Elizabeth University Hospital, Glasgow, UK (aq) Department of Medicine, University of Cambridge, UK (ar) Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK (as) Heart Lung Research Institute, Dept of Medicine, University of Cambridge and NIHR Cambridge Clinical Research Facility, Cambridge University Hospital and Royal Papworth NHS Foundation Trusts, Cambridge, UK (at) University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham, UK (au) Public Health Wales, Cardiff, Wales (av) Aneurin Bevan University Health Board, Newport, Wales * Correspondence to: Prof Andrew J Pollard, Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford OX3 7LE, UK (footnote)* Contributed equally (footnote)[Dagger] Members are listed in the appendix (p 27) Byline: Merryn Voysey, DPhil (a), Sue Ann Costa Clemens, MD (c,d), Shabir A Madhi, PhD (f,g), Lily Y Weckx, MD (j), Pedro M Folegatti, MD (b), Parvinder K Aley, DPhil (a), Brian Angus, MD (b), Vicky L Baillie, PhD (f,g), Shaun L Barnabas, PhD (l), Qasim E Bhorat, MSc (m), Sagida Bibi, PhD (a), Carmen Briner, MBBCh (i), Paola Cicconi, MD (b), Elizabeth A Clutterbuck, PhD (a), Andrea M Collins, PhD (n), Clare L Cutland, MD (f,g), Thomas C Darton, DPhil (o,p), Keertan Dheda, FRCPCH (s,t), Christina Dold, PhD (a), Christopher J A Duncan, DPhil (u,v), Katherine R W Emary, FRCPath (a), Katie J Ewer, PhD (b), Amy Flaxman, DPhil (b), Lee Fairlie, FCPaeds (h), Saul N Faust, PhD (w,x), Shuo Feng, PhD (a), Daniela M Ferreira, PhD (n), Adam Finn, FRCPCH (y), Eva Galiza, MBBS (ac), Anna L Goodman, FRCP (z,aa), Catherine M Green, PhD (e), Christopher A Green, DPhil (ab), Melanie Greenland, MSc (a), Catherine Hill, BA (f,g), Helen C Hill, PhD (n), Ian Hirsch, PhD (k), Alane Izu, PhD (f,g), Daniel Jenkin, MRCP (b), Carina C D Joe, PhD (b), Simon Kerridge, MSc (a), Anthonet Koen, MBChB (f,g), Gaurav Kwatra, PhD (f,g), Rajeka Lazarus, DPhil (ad), Vincenzo Libri, FRCP (ae), Patrick J Lillie, PhD (af), Natalie G Marchevsky, MSc (a), Richard P Marshall, MD (k), Ana V A Mendes, MD (q,r), Eveline P Milan, PhD (ai), Angela M Minassian, DPhil (b), Alastair McGregor, FRCPath (ag), Yama F Mujadidi, MSc (a), Anusha Nana, BPharm (i), Sherman D Padayachee, MBChB (ah), Daniel J Phillips, MMath (a), Ana Pittella, MD (aj), Emma Plested (a), Katrina M Pollock, PhD (ak), Maheshi N Ramasamy, DPhil (a), Adam J Ritchie, PhD (b), Hannah Robinson, RN (a), Alexandre V Schwarzbold, PhD (an), Andrew Smith, FRCPath (al), Rinn Song, MD (a), Matthew D Snape, MD (a), Eduardo Sprinz, MD (am), Rebecca K Sutherland, FRCP (ao), Emma C Thomson, FRCP PhD (ap), M Estée Török, FRCP (aq,ar), Mark Toshner, MD (as), David P J Turner, PhD (at), Johan Vekemans, MD PhD (k), Tonya L Villafana, PhD (k), Thomas White, PhD (k), Christopher J Williams, FFPH (au,av), Alexander D Douglas, DPhil (b), Adrian V S Hill, FMedSci (b), Teresa Lambe, PhD (b), Sarah C Gilbert, PhD (b), Prof Andrew J Pollard, FMedSci [andrew.pollard@paediatrics.ox.ac.uk] (a), Marites Aban, Kushala W.M. 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Bewley, Inderjeet Bharaj, Sutika Bhikha, Asad E. Bhorat, Zaheda E. Bhorat, Else Margreet Bijker, Sarah Birch, Gurpreet Birch, Kathryn Birchall, Adam Bird, Olivia Bird, Karen Bisnauthsing, Mustapha Bittaye, Luke Blackwell, Rachel Blacow, Heather Bletchly, Caitlin L. Blundell, Susannah R. Blundell, Pritesh Bodalia, Emma Bolam, Elena Boland, Daan Bormans, Nicola Borthwick, Francesca Bowring, Amy Boyd, Penny Bradley, Tanja Brenner, Alice Bridges-Webb, Phillip Brown, Claire Brown, Charlie Brown-O'Sullivan, Scott Bruce, Emily Brunt, William Budd, Yusuf A. Bulbulia, Melanie Bull, Jamie Burbage, Aileen Burn, Karen R. Buttigieg, Nicholas Byard, Ingrid Cabrera Puig, Anna Calvert, Susana Camara, Michelangelo Cao, Federica Cappuccini, Rita Cardona, João R. Cardoso, Melanie Carr, Miles W. Carroll, Andrew Carson-Stevens, Yasmin de M. Carvalho, Helen R. Casey, Paul Cashen, Thais R.Y. Castro, Lucia Carratala Castro, Katrina Cathie, Ana Cavey, José Cerbino-Neto, Luiz Fernando F. Cezar, Jim Chadwick, Chanice Chanice, David Chapman, Sue Charlton, Katerina S. Cheliotis, Irina Chelysheva, Oliver Chester, Emily Chiplin, Sunder Chita, Jee-Sun Cho, Liliana Cifuentes, Elizabeth Clark, Matthew Clark, Rachel Colin-Jones, Sarah L.K. Collins, Hayley Colton, Christopher P. Conlon, Sean Connarty, Naomi Coombes, Cushla Cooper, Rachel Cooper, Lynne Cornelissen, Tumena Corrah, Catherine A. Cosgrove, Fernanda Barroso Costa, Tony Cox, Wendy E.M. Crocker, Sarah Crosbie, Dan Cullen, Debora R.M.F. Cunha, Christina J. Cunningham, Fiona C. Cuthbertson, Daniel Marinho da Costa, Suzete N. Farias Da Guarda, Larissa P. da Silva, Antonio Carlos da Silva Moraes, Brad E. Damratoski, Zsofia Danos, Maria T.D.C. Dantas, Mehreen S. Datoo, Chandrabali Datta, Malika Davids, Sarah L. Davies, Kelly Davies, Hannah Davies, Sophie Davies, Judith Davies, Elizabeth J. Davis, John Davis, José A.M. de Carvalho, Jeanne De Jager, Sergio de Jesus Jnr, Lis Moreno De Oliveira Kalid, David Dearlove, Tesfaye Demissie, Amisha Desai, Stefania Di Marco, Claudio Di Maso, Tanya Dinesh, Claire Docksey, Tao Dong, Francesca R. Donnellan, Tannyth Gomes Dos Santos, Thainá G. Dos Santos, Erika Pachecho Dos Santos, Naomi Douglas, Charlotte Downing, Jonathan Drake, Rachael Drake-Brockman, Ruth Drury, Joan Du Plessis, Susanna J. Dunachie, Andrew Duncan, Nicholas J.W. Easom, Mandy Edwards, Nick J. Edwards, Frances Edwards, Omar M. El Muhanna, Sean C. Elias, Branwen Ellison-Handley, Michael J. Elmore, Marcus Rex English, Alisgair Esmail, Yakub Moosa Essack, Mutjaba Farooq, Sofiya Fedosyuk, Sally Felle, Susie Ferguson, Carla Ferreira Da Silva, Samantha Field, Richard Fisher, James Fletcher, Hazel Fofie, Henry Fok, Karen J. Ford, Ross Fothergill, Jamie Fowler, Pedro H.A. Fraiman, Emma Francis, Marilia M. Franco, John Frater, Marilúcia S.M. Freire, Samantha H. Fry, Sabrina Fudge, Renato Furlan Filho, Julie Furze, Michelle Fuskova, Pablo Galian-Rubio, Harriet Garlant, Madita Gavrila, Karyna A. Gibbons, Ciaran Gilbride, Hardeep Gill, Kerry Godwin, Karishma Gokani, Maria Luisa Freire Gonçalves, Isabela G.S. Gonzalez, Jack Goodall, Jayne Goodwin, Amina Goondiwala, Katherine Gordon-Quayle, Giacomo Gorini, Alvaro Goyanna, Janet Grab, Lara Gracie, Justin Green, Nicola Greenwood, Johann Greffrath, Marisa M. Groenewald, Anishka Gunawardene, Gaurav Gupta, Mark Hackett, Bassam Hallis, Mainga Hamaluba, Elizabeth Hamilton, Joseph Hamlyn, Daniel Hammersley, Aidan T. Hanrath, Brama Hanumunthadu, Stephanie A. Harris, Clair Harris, Thomas D. Harrison, Daisy Harrison, Tara A. Harris-Wright, Thomas C. Hart, Birgit Hartnell, John Haughney, Sophia Hawkins, Laís Y.M. Hayano, Ian Head, Paul T. Heath, John Aaron Henry, Macarena Hermosin Herrera, David B. Hettle, Cristhiane Higa, Jennifer Hill, Gina Hodges, Susanne Hodgson, Elizea Horne, Mimi M. Hou, Catherine F. Houlihan, Elizabeth Howe, Nicola Howell, Jonathan Humphreys, Holly E. Humphries, Katrina Hurley, Claire Huson, Catherine Hyams, Angela Hyder-Wright, Sabina Ikram, Alka Ishwarbhai, Poppy Iveson, Vidyashankara Iyer, Frederic Jackson, Susan Jackson, Shameem Jaumdally, Helen Jeffers, Natasha Jesudason, Carina Jones, Christopher Jones, Kathryn Jones, Elizabeth Jones, Marianna Rocha Jorge, Amar Joshi, Eduardo A.M.S. Júnior, Reshma Kailath, Faeeza Kana, Arnab Kar, Konstantinos Karampatsas, Mwila Kasanyinga, Linda Kay, Jade Keen, Johanna Kellett Wright, Elizabeth J. Kelly, Debbie Kelly, Dearbhla M. Kelly, Sarah Kelly, David Kerr, Liaquat Khan, Baktash Khozoee, Ankush Khurana, Sarah Kidd, Annabel Killen, Jasmin Kinch, Patrick Kinch, Lloyd D.W. King, Thomas B. King, Lucy Kingham, Paul Klenerman, Diana M. Kluczna, Francesca Knapper, Julian C. Knight, Daniel Knott, Stanislava Koleva, Pedro M. Lages, Matilda Lang, Gail Lang, Colin W. Larkworthy, Jessica P.J. Larwood, Rebecca Law, Alison M. 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