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37 PagesPosted: 1 Feb 2021
See all articles by Merryn Voysey
Merryn Voysey
University of Oxford - Oxford Vaccine Group
Sue Ann Costa Clemens
University of Siena - Institute of Global Health
Shabir A. Madhi
University of the Witwatersrand - Vaccines and Infectious Diseases Analytics Research Unit
Lily Yin Weckx
Federal University of São Paulo (UNIFESP)
Pedro M. Folegatti
University of Oxford - The Jenner Institute
Parvinder K. Aley
University of Oxford - Centre for Vaccinology and Tropical Medicine
Brian John Angus
University of Oxford - Oxford Vaccine Group
Vicky Baillie
University of the Witwatersrand
Shaun L. Barnabas
Stellenbosch University - Family Centre for Research with Ubuntu
Qasim E. Bhorat
Soweto Clinical Trials Centre
Sagida Bibi
University of Oxford - Centre for Vaccinology and Tropical Medicine
Carmen Briner
University of the Witwatersrand - Vaccines and Infectious Diseases Analytics Research Unit
Paola Cicconi
University of Oxford - The Jenner Institute; University of Oxford - Oxford Vaccine Group
Elizabeth Clutterbuck
University of Oxford - Centre for Vaccinology and Tropical Medicine
Andrea M. Collins
Liverpool School of Tropical Medicine - Department of Clinical Sciences
Clare Cutland
University of the Witwatersrand - South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit
Thomas Darton
University of Sheffield - Department of Infection, Immunity and Cardiovascular Disease
Keertan Dheda
University of Cape Town (UCT) - Centre for Lung Infection and Immunity
Alexander D. Douglas
University of Oxford - Jenner Institute
Christopher J. A. Duncan
Newcastle upon Tyne Hospitals NHS Foundation Trust - Department of Infection and Tropical Medicine
Katherine R. W. Emary
University of Oxford - Oxford Vaccine Group
Katie Ewer
GSK plc; University of Oxford - The Jenner Institute
Amy Flaxman
University of Oxford - The Jenner Institute
Lee Fairlie
Wits Reproductive Health & HIV Institute (WRHI)
Saul N. Faust
University of Southampton - NIHR Southampton Clinical Research Facility and Biomedical Research Centre
Shuo Feng
University of Oxford - Oxford Vaccine Group
Daniela M. Ferreira
University of Liverpool - School of Tropical Medicine
Adam Finn
University of Bristol - Bristol Vaccine Centre
Eva Galiza
St George’s University London - St George’s Vaccine Institute
Anna L. Goodman
University College London - Department of Infection
Catherine M. Green
University of Oxford - Clinical BioManufacturing Facility
Christopher A. Green
University Hospitals Birmingham NHS Foundation Trust
Melanie Greenland
University of Oxford - Oxford Vaccine Group
Catherine Hill
University of the Witwatersrand - South African Medical Research Council
Helen C. Hill
Liverpool School of Tropical Medicine - Department of Clinical Sciences
Ian Hirsch
AstraZeneca Pharmaceuticals
Alane Izu
University of the Witwatersrand - South African Medical Research Council
Daniel Jenkin
University of Oxford - The Jenner Institute
Simon Kerridge
University of Oxford - Centre for Vaccinology and Tropical Medicine
Anthonet Koen
University of the Witwatersrand - South African Medical Research Council
Gaurav Kwatra
University of the Witwatersrand - South African Medical Research Council
Rajeka Lazarus
University Hospitals Bristol - University Hospitals Bristol and Weston NHS Foundation Trust
Vincenzo Libri
NIHR UCLH Clinical Research Facility
Patrick J. Lillie
Hull University Teaching Hospitals NHS Trust
Natalie G. Marchevsky
University of Oxford - Centre for Vaccinology and Tropical Medicine
Richard P. Marshall
AstraZeneca Pharmaceuticals
Ana Verena Almeida Mendes
Braziland Hospital São Rafael - Escola Bahiana de Medicina e Saúde Pública
Eveline P. Milan
Universidade Federal do Rio Grande do Norte (UFRN)
Angela M. Minassian
University of Oxford - The Jenner Institute
Alastair C. McGregor
London Northwest University Healthcare
Yama Farooq Mujadidi
University of Oxford - Oxford Vaccine Group
Anusha Nana
University of the Witwatersrand - Perinatal HIV Research Unit
Sherman D. Payadachee
Setshaba Research Centre
Daniel J. Phillips
University of Oxford - Oxford Vaccine Group
Ana Pittella
Hospital Quinta D'OR
Emma Plested
University of Oxford - Oxford Vaccine Group
Katrina M. Pollock
Imperial College London - Department of Infectious Disease
Maheshi N. Ramasamy
University of Oxford - Oxford Vaccine Group
Hannah Robinson
University of Oxford - Oxford Vaccine Group
Alexandre Vargas Schwarzbold
Hospital Universitário de Santa Maria
Andrew Smith
University of Glasgow - College of Medical, Veterinary & Life Sciences
Rinn Song
University of Oxford - Centre for Vaccinology and Tropical Medicine
Matthew D. Snape
University of Oxford - Centre for Vaccinology and Tropical Medicine
Eduardo Sprinz
Universidade Federal do Rio Grande do Sul
Rebecca K. Sutherland
Western General Hospital - Clinical Infection Research Group
Emma C. Thomson
MRC-University of Glasgow Centre for Virus Research
Mili Estée Török
University of Cambridge - Department of Medicine; NHS Foundation Trust - Cambridge University Hospitals
Mark Toshner
Royal Papworth Hospital; University of Cambridge - Heart and Lung Research Institute
David P. J. Turner
Nottingham University Hospitals NHS Trust
Johan Vekemans
AstraZeneca Biopharmaceuticals
Tonya L. Villafana
AstraZeneca Pharmaceuticals
Thomas White
AstraZeneca Pharmaceuticals
Christopher J. Williams
Anuerin Bevan University Health Board
Adrian V. S. Hill
University of Oxford - The Jenner Institute; University of Oxford - Wellcome Trust Centre for Human Genetics; University of Oxford - Centre for Clinical Vaccinology and Tropical Medicine
Teresa Lambe
University of Oxford - The Jenner Institute
Sarah C. Gilbert
University of Oxford - Chinese Academy of Medical Science Oxford Institute (COI)
Andrew J. Pollard
University of Oxford - Oxford Vaccine Group
Oxford COVID Vaccine Trial Group
Independent
More...
Abstract
Background: The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, MHRA, with a regimen of two standard doses given with an interval of between 4 and 12 weeks. The planned rollout 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 phase III efficacy trials of ChAdOx1 nCoV-19 in the United Kingdom and Brazil, and phase I/II clinical trials in the UK and South Africa, against symptomatic disease caused by SARS-CoV-2. The data cut-off date for these analyses was 7th December 2020. The accumulated cases of COVID-19 disease at this cut-off date exceeds the number required for a pre-specified final analysis, which is also presented. As previously described, individuals over 18 years of age were randomised 1:1 to receive two standard doses (SD) of ChAdOx1 nCoV-19 (5x1010 viral particles) or a control vaccine/saline placebo. In the UK trial efficacy cohort a subset of participants received a lower dose (LD, 2.2x1010 viral particles) of the ChAdOx1 nCoV-19 for the first dose. All cases with a nucleic acid amplification test (NAAT) were adjudicated for inclusion in the analysis, by a blinded independent endpoint review committee. Studies are registered atISRCTN89951424and ClinicalTrials.gov; NCT04324606, NCT04400838,and NCT04444674.
Findings: 17,177 baseline seronegative trial participants were eligible for inclusion in the efficacy analysis, 8948 in the UK, 6753 in Brazil and 1476 in South Africa, with 619 documented NAAT +ve infections of which 332 met the primary endpoint of symptomatic infection >14 days post dose 2.The primary analysis of overall vaccine efficacy >14 days after the second dose including LD/SD and SD/SD groups, based on the prespecified criteria was 66.7% (57.4%, 74.0%). There were no hospitalisations in the ChAdOx1 nCoV-19 group after the initial 21 day exclusion period, and 15 in the control group.Vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 post vaccination was 76% (59%, 86%), and modelled 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 day (GMR 0.66, 95% CI 0.59, 0.74).In the SD/SD group, after the second dose, efficacy was higher with a longer prime-boost interval: VE 82.4% 95%CI 62.7%, 91.7% at 12+ weeks, compared with VE 54.9%, 95%CI 32.7%, 69.7% at <6 weeks. These observations are supported by immunogenicity data which showed binding antibody responses more than 2-fold higher after an interval of 12 or more weeks compared with and interval of less than 6 weeks GMR 2.19 (2.12, 2.26) in those who were 18-55 years of age.
Interpretation: ChAdOx1 nCoV-19 vaccination programmes aimed at vaccinating a large proportion of the population with a single dose, with a second dose given after a 3 month period is an effective strategy for reducing disease, and may be the optimal for rollout of a pandemic vaccine when supplies are limited in the short term.
Trial Registration: Studies are registered at ISRCTN89951424 and ClinicalTrials.gov; NCT04324606, NCT04400838, and NCT04444674.
Funding: UKRI, NIHR, CEPI, 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 Astra Zeneca.
Conflict of Interest: Oxford University has entered into a partnership with Astra Zeneca for further development of ChAdOx1 nCoV-19. SCG is co-founder of Vaccitech (collaborators in the early development of this vaccine candidate) and named as an inventor on a patent covering use of ChAdOx1-vectored vaccines and a patent application covering this SARS-CoV-2 vaccine. TL is named as aninventor on a patent application covering this SARS-CoV-2 vaccine and was a consultant to Vaccitech for an unrelated project. PMF is a consultant to Vaccitech. AJP is Chair of UK Dept.Health and Social Care’s (DHSC) Joint Committee on Vaccination & Immunisation (JCVI), but does not participate in discussions on COVID-19 vaccines, and is a member of the WHO’sSAGE. AJP and SNF are NIHR Senior Investigator. The views expressed in this article do not necessarily represent the views of DHSC, JCVI, NIHR or WHO. AVSH reports personal feesfrom Vaccitech, outside the submitted work and has a patent on ChAdOx1 licensed to Vaccitech, and may benefit from royalty income to the University of Oxford from sales of this vaccine by AstraZeneca and sublicensees. MS reports grants from NIHR, non-financial support fromAstraZeneca, during the conduct of the study; grants from Janssen, grants fromGlaxoSmithKline, grants from Medimmune, grants from Novavax, grants and non-financialsupport from Pfizer, grants from MCM, outside the submitted work. CG reports personal fees from the Duke Human Vaccine Institute, outside of the submitted work. SNF reports grants from Janssen and Valneva, outside the submitted work. ADD reports grants and personal fees from AstraZeneca, outside of the submitted work. In addition, ADD has a patent manufacturingprocess for ChAdOx vectors with royalties paid to AstraZeneca, and a patent ChAdOx2 vector with royalties paid to AstraZeneca. The other authors declare no competing interests.
Suggested Citation:Suggested Citation
Voysey, Merryn and Costa Clemens, Sue Ann and Madhi, Shabir A. and Weckx, Lily Yin and Folegatti, Pedro M. and Aley, Parvinder K. and Angus, Brian John and Baillie, Vicky and Barnabas, Shaun L. and Bhorat, Qasim E. and Bibi, Sagida and Briner, Carmen and Cicconi, Paola and Clutterbuck, Elizabeth and Collins, Andrea M. and Cutland, Clare and Darton, Thomas and Dheda, Keertan and Douglas, Alexander D. and Duncan, Christopher J. A. and Emary, Katherine R. W. and Ewer, Katie and Flaxman, Amy and Fairlie, Lee and Faust, Saul N. and Feng, Shuo and Ferreira, Daniela M. and Finn, Adam and Galiza, Eva and Goodman, Anna L. and Green, Catherine M. and Green, Christopher A. and Greenland, Melanie and Hill, Catherine and Hill, Helen C. and Hirsch, Ian and Izu, Alane and Jenkin, Daniel and Kerridge, Simon and Koen, Anthonet and Kwatra, Gaurav and Lazarus, Rajeka and Libri, Vincenzo and Lillie, Patrick J. and Marchevsky, Natalie G. and Marshall, Richard P. and Mendes, Ana Verena Almeida and Milan, Eveline P. and Minassian, Angela M. and McGregor, Alastair C. and Farooq Mujadidi, Yama and Nana, Anusha and Payadachee, Sherman D. and Phillips, Daniel J. and Pittella, Ana and Plested, Emma and Pollock, Katrina M. and Ramasamy, Maheshi N. and Robinson, Hannah and Schwarzbold, Alexandre Vargas and Smith, Andrew and Song, Rinn and Snape, Matthew D. and Sprinz, Eduardo and Sutherland, Rebecca K. and Thomson, Emma C. and Török, Mili Estée and Toshner, Mark and Turner, David P. J. and Vekemans, Johan and Villafana, Tonya L. and White, Thomas and Williams, Christopher J. and Hill, Adrian V. S. and Lambe, Teresa and Gilbert, Sarah C. and Pollard, Andrew J. and Group, Oxford COVID Vaccine Trial, Single DoseAdministration,AndTheInfluence OfTheTiming OfTheBooster DoseOn Immunogenicity and Efficacy OfChAdOx1 nCoV-19(AZD1222)Vaccine. Available at SSRN: https://ssrn.com/abstract=3777268 or http://dx.doi.org/10.2139/ssrn.3777268
Merryn Voysey
University of Oxford - Oxford Vaccine Group
Sue Ann Costa Clemens
University of Siena - Institute of Global Health
Via Banchi di Sotto, 55
Siena, 53100
Italy
Shabir A. Madhi
University of the Witwatersrand - Vaccines and Infectious Diseases Analytics Research Unit ( email )
Lily Yin Weckx
Federal University of São Paulo (UNIFESP) ( email )
Pedro M. Folegatti
University of Oxford - The Jenner Institute
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Parvinder K. Aley
University of Oxford - Centre for Vaccinology and Tropical Medicine ( email )
Oxford
United Kingdom
Brian John Angus
University of Oxford - Oxford Vaccine Group ( email )
Oxford
United Kingdom
Vicky Baillie
University of the Witwatersrand
1 Jan Smuts Avenue
Johannesburg, GA 2000
South Africa
Shaun L. Barnabas
Stellenbosch University - Family Centre for Research with Ubuntu ( email )
Qasim E. Bhorat
Soweto Clinical Trials Centre ( email )
Sagida Bibi
University of Oxford - Centre for Vaccinology and Tropical Medicine ( email )
Oxford
United Kingdom
Carmen Briner
University of the Witwatersrand - Vaccines and Infectious Diseases Analytics Research Unit
Paola Cicconi
University of Oxford - The Jenner Institute
Mansfield Road
Oxford, OX1 4AU
United Kingdom
University of Oxford - Oxford Vaccine Group ( email )
Oxford
United Kingdom
Elizabeth Clutterbuck
University of Oxford - Centre for Vaccinology and Tropical Medicine ( email )
Oxford
United Kingdom
Andrea M. Collins
Liverpool School of Tropical Medicine - Department of Clinical Sciences
Liverpool
United Kingdom
Clare Cutland
University of the Witwatersrand - South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit ( email )
7 York Rd
Parktown, Johannesburg 2193
South Africa
Thomas Darton
University of Sheffield - Department of Infection, Immunity and Cardiovascular Disease ( email )
17 Mappin Street
Sheffield, Sheffield S1 4DT
United Kingdom
Keertan Dheda
University of Cape Town (UCT) - Centre for Lung Infection and Immunity ( email )
Cape Town
South Africa
Alexander D. Douglas
University of Oxford - Jenner Institute
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Christopher J. A. Duncan
Newcastle upon Tyne Hospitals NHS Foundation Trust - Department of Infection and Tropical Medicine ( email )
Newcastle
United Kingdom
Katherine R. W. Emary
University of Oxford - Oxford Vaccine Group
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Katie Ewer
GSK plc ( email )
Brentford
United Kingdom
University of Oxford - The Jenner Institute ( email )
Old Road Campus Research Building Roosevelt Drive
Oxford, Oxfordshire OX3 7DQ
United Kingdom
Amy Flaxman
University of Oxford - The Jenner Institute ( email )
Old Road Campus Research Building Roosevelt Drive
Oxford, Oxfordshire OX3 7DQ
United Kingdom
Lee Fairlie
Wits Reproductive Health & HIV Institute (WRHI)
Klein St & Esselen St
Hillbrow, Johannesburg
South Africa
Saul N. Faust
University of Southampton - NIHR Southampton Clinical Research Facility and Biomedical Research Centre ( email )
Southampton
United Kingdom
Shuo Feng
University of Oxford - Oxford Vaccine Group
Oxford
United Kingdom
Daniela M. Ferreira
University of Liverpool - School of Tropical Medicine
Adam Finn
University of Bristol - Bristol Vaccine Centre ( email )
Eva Galiza
St George’s University London - St George’s Vaccine Institute ( email )
Anna L. Goodman
University College London - Department of Infection ( email )
Gower Street
London, WC1E 6BT
United Kingdom
Catherine M. Green
University of Oxford - Clinical BioManufacturing Facility
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Christopher A. Green
University Hospitals Birmingham NHS Foundation Trust
Mindelsohn Way
Edgbaston
Birmingham, B15 2TH
United Kingdom
Melanie Greenland
University of Oxford - Oxford Vaccine Group
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Catherine Hill
University of the Witwatersrand - South African Medical Research Council
296 Umbilo Rd.
Durban 4000
South Africa
Helen C. Hill
Liverpool School of Tropical Medicine - Department of Clinical Sciences
Liverpool
United Kingdom
Ian Hirsch
AstraZeneca Pharmaceuticals ( email )
1800 Concord Pike
Wilmington, DE 19803
United States
Alane Izu
University of the Witwatersrand - South African Medical Research Council
296 Umbilo Rd.
Durban 4000
South Africa
Daniel Jenkin
University of Oxford - The Jenner Institute
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Simon Kerridge
University of Oxford - Centre for Vaccinology and Tropical Medicine ( email )
Oxford
United Kingdom
Anthonet Koen
University of the Witwatersrand - South African Medical Research Council
296 Umbilo Rd.
Durban 4000
South Africa
Gaurav Kwatra
University of the Witwatersrand - South African Medical Research Council
Rajeka Lazarus
University Hospitals Bristol - University Hospitals Bristol and Weston NHS Foundation Trust ( email )
Bristol
United Kingdom
Vincenzo Libri
NIHR UCLH Clinical Research Facility
Patrick J. Lillie
Hull University Teaching Hospitals NHS Trust ( email )
Natalie G. Marchevsky
University of Oxford - Centre for Vaccinology and Tropical Medicine
Oxford
United Kingdom
Richard P. Marshall
AstraZeneca Pharmaceuticals ( email )
1800 Concord Pike
Wilmington, DE 19803
United States
Ana Verena Almeida Mendes
Braziland Hospital São Rafael - Escola Bahiana de Medicina e Saúde Pública ( email )
Eveline P. Milan
Universidade Federal do Rio Grande do Norte (UFRN) ( email )
PO Box 1524
Natal-RN, 59078970
Brazil
Angela M. Minassian
University of Oxford - The Jenner Institute
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Alastair C. McGregor
London Northwest University Healthcare ( email )
Yama Farooq Mujadidi
University of Oxford - Oxford Vaccine Group
Anusha Nana
University of the Witwatersrand - Perinatal HIV Research Unit ( email )
1 Jan Smuts Avenue
Johannesburg, GA Gauteng 2000
South Africa
Sherman D. Payadachee
Setshaba Research Centre ( email )
Soshanguve
South Africa
Daniel J. Phillips
University of Oxford - Oxford Vaccine Group
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Ana Pittella
Hospital Quinta D'OR ( email )
Emma Plested
University of Oxford - Oxford Vaccine Group
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Katrina M. Pollock
Imperial College London - Department of Infectious Disease ( email )
Maheshi N. Ramasamy
University of Oxford - Oxford Vaccine Group
Mansfield Road
Oxford, OX1 4AU
United Kingdom
Hannah Robinson
University of Oxford - Oxford Vaccine Group
Oxford
United Kingdom
Alexandre Vargas Schwarzbold
Hospital Universitário de Santa Maria ( email )
Santa Maria
Brazil
Andrew Smith
University of Glasgow - College of Medical, Veterinary & Life Sciences
Adam Smith Business School
Glasgow, Scotland G12 8LE
United Kingdom
Rinn Song
University of Oxford - Centre for Vaccinology and Tropical Medicine ( email )
Oxford
United Kingdom
Matthew D. Snape
University of Oxford - Centre for Vaccinology and Tropical Medicine ( email )
Oxford
United Kingdom
Eduardo Sprinz
Universidade Federal do Rio Grande do Sul
Rua Washington Luiz #855
Porto Alegre, 90010460
Brazil
Rebecca K. Sutherland
Western General Hospital - Clinical Infection Research Group ( email )
Edinburgh
United Kingdom
Emma C. Thomson
MRC-University of Glasgow Centre for Virus Research ( email )
Glasgow
United Kingdom
Mili Estée Török
University of Cambridge - Department of Medicine ( email )
United Kingdom
NHS Foundation Trust - Cambridge University Hospitals ( email )
Hills Road
Cambridge, CB2 0QQ
United Kingdom
Mark Toshner
Royal Papworth Hospital ( email )
Papworth Everard
Cambridge, England CB23 3RE
United Kingdom
University of Cambridge - Heart and Lung Research Institute ( email )
Cambridge
United Kingdom
David P. J. Turner
Nottingham University Hospitals NHS Trust ( email )
Nottingham
United Kingdom
Johan Vekemans
AstraZeneca Biopharmaceuticals ( email )
Cambridge
United Kingdom
Tonya L. Villafana
AstraZeneca Pharmaceuticals ( email )
1800 Concord Pike
Wilmington, DE 19803
United States
Thomas White
AstraZeneca Pharmaceuticals
1800 Concord Pike
Wilmington, DE 19803
United States
Christopher J. Williams
Anuerin Bevan University Health Board ( email )
Newport
United Kingdom
Adrian V. S. Hill
University of Oxford - The Jenner Institute
Old Road Campus Research Building Roosevelt Drive
Oxford, Oxfordshire OX3 7DQ
United Kingdom
University of Oxford - Wellcome Trust Centre for Human Genetics ( email )
Old Road Campus
Roosevelt Drive
Oxford, OX3 7FZ
United Kingdom
University of Oxford - Centre for Clinical Vaccinology and Tropical Medicine ( email )
Oxford
United Kingdom
Teresa Lambe
University of Oxford - The Jenner Institute ( email )
Old Road Campus Research Building Roosevelt Drive
Oxford, Oxfordshire OX3 7DQ
United Kingdom