Evidence map›Paper›PMID 33335322›Full record

Trial reportNature medicine2021

Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses.

Jordan R Barrett, Sandra Belij-Rammerstorfer, Christina Dold, Katie J Ewer, Pedro M Folegatti, Ciaran Gilbride, Rachel Halkerston, Jennifer Hill, Daniel Jenkin, Lisa Stockdale and 45 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04324606 (A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease), which is not on this map. Cited by 212 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
212citing papers in PubMed, 12 pooled it
7.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04324606 phase1 / phase2completednot on this map

A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers

TypeinterventionalSponsorUniversity of OxfordRan2020 to 2025Enrolled1,077ConditionsCoronavirusArmsChAdOx1 nCoV-19, MenACWY, ChAdOx1 nCoV-19 full boost, ChAdOx1 nCoV-19 half boost, MenACWY boost
3 · Its place in the literature

Who cites it

212 citing papers in PubMed, 12 syntheses or guidelines pooled it, 336 citations in OpenAlex.

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  3. Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022
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  20. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
    Trial

152 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

55 authors at 6 institutions in 3 countries.

Jordan R Barrett *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0003-0746-1945
Sandra Belij-Rammerstorfer *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Christina Dold *Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Katie J Ewer *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-9827-9836
Pedro M Folegatti *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-5330-0240
Ciaran Gilbride *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Rachel Halkerston *Public Health England, Salisbury, UK.
Jennifer Hill *Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Daniel Jenkin *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Daniel.Jenkin@ndm.ox.ac.uk.ORCID http://orcid.org/0000-0003-3088-310X
Lisa Stockdale *Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-2576-8783
Marije K Verheul *Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Parvinder K AleyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Brian AngusNuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0003-3598-7784
Duncan BellamyThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Eleanor BerrieClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Sagida BibiOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Mustapha BittayeThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Miles W CarrollClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Breeze CavellPublic Health England, Salisbury, UK.
Elizabeth A ClutterbuckOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Nick EdwardsThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-7030-7839
Amy FlaxmanThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Michelle FuskovaThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-2146-4299
Andrew GorringePublic Health England, Salisbury, UK.ORCID http://orcid.org/0000-0003-2193-7954
Bassam HallisPublic Health England, Salisbury, UK.
Simon KerridgeThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Alison M LawrieThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Aline LinderOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Xinxue LiuOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Meera MadhavanThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Rebecca MakinsonThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Jack MellorsPublic Health England, Salisbury, UK.
Angela MinassianThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-7832-9824
Maria MooreOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Yama MujadidiOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-2342-8531
Emma PlestedOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Ian PoultonThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6603-8461
Maheshi N RamasamyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-2119-951X
Hannah RobinsonOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Christine S RollierOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-9712-8080
Rinn SongOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-6877-1096
Matthew D SnapeOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Richard TarrantClinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Stephen TaylorPublic Health England, Salisbury, UK.ORCID http://orcid.org/0000-0002-9936-8539
Kelly M ThomasPublic Health England, Salisbury, UK.ORCID http://orcid.org/0000-0002-0348-654X
Merryn VoyseyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Marion E E WatsonThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-8570-2113
Daniel WrightThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-8114-1838
Alexander D DouglasThe Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-5410-7562
Catherine M Green *Clinical BioManufacturing Facility, The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Adrian V S Hill *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0003-0900-9629
Teresa Lambe *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-7711-897X
Sarah Gilbert *The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-6823-9750
Andrew J Pollard *Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK. Andrew.Pollard@paediatrics.ox.ac.uk.ORCID http://orcid.org/0000-0001-7361-719X
Oxford COVID Vaccine Trial Group
University of Oxford · GBPublic Health England · GBLabCorp (United States) · USAcademy of Medical Sciences · GBCentre for Human Genetics · GBOxford University Hospitals NHS Trust · GB

Funding

Medical Research Council G0600520Medical Research Council G1001046Medical Research Council MC_PC_19055Medical Research Council MC_PC_19058Medical Research Council MC_UU_00008/11Medical Research Council MR/L006588/1Medical Research Council MR/L018942/1Medical Research Council MR/T001151/1Wellcome Trust 109965/Z/15/Z
6 · The paper itself

Abstract

More than 190 vaccines are currently in development to prevent infection by the novel severe acute respiratory syndrome coronavirus 2. Animal studies suggest that while neutralizing antibodies against the viral spike protein may correlate with protection, additional antibody functions may also be important in preventing infection. Previously, we reported early immunogenicity and safety outcomes of a viral vector coronavirus vaccine, ChAdOx1 nCoV-19 (AZD1222), in a single-blinded phase 1/2 randomized controlled trial of healthy adults aged 18-55 years ( NCT04324606 ). Now we describe safety and exploratory humoral and cellular immunogenicity of the vaccine, from subgroups of volunteers in that trial, who were subsequently allocated to receive a homologous full-dose (SD/SD D56; n = 20) or half-dose (SD/LD D56; n = 32) ChAdOx1 booster vaccine 56 d following prime vaccination. Previously reported immunogenicity data from the open-label 28-d interval prime-boost group (SD/SD D28; n = 10) are also presented to facilitate comparison. Additionally, we describe volunteers boosted with the comparator vaccine (MenACWY; n = 10). In this interim report, we demonstrate that a booster dose of ChAdOx1 nCoV-19 is safe and better tolerated than priming doses. Using a systems serology approach we also demonstrate that anti-spike neutralizing antibody titers, as well as Fc-mediated functional antibody responses, including antibody-dependent neutrophil/monocyte phagocytosis, complement activation and natural killer cell activation, are substantially enhanced by a booster dose of vaccine. A booster dose of vaccine induced stronger antibody responses than a dose-sparing half-dose boost, although the magnitude of T cell responses did not increase with either boost dose. These data support the two-dose vaccine regime that is now being evaluated in phase 3 clinical trials.

Indexed as

Immunization, SecondaryAdolescentAdultAntibodies, NeutralizingAntibody FormationChAdOx1 nCoV-19COVID-19COVID-19 VaccinesDose-Response Relationship, DrugGenetic VectorsHumansMiddle AgedSARS-CoV-2Spike Glycoprotein, CoronavirusTime FactorsYoung AdultAntibodies, NeutralizingChAdOx1 nCoV-19COVID-19 VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2

Identifiers

PMID33335322
OpenAlexW3111128314

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.