Evidence map›Paper›PMID 33220855›Full record

Trial reportLancet (London, England)2021

Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial.

Maheshi N Ramasamy, Angela M Minassian, Katie J Ewer, Amy L Flaxman, Pedro M Folegatti, Daniel R Owens, Merryn Voysey, Parvinder K Aley, Brian Angus, Gavin Babbage and 55 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 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 NCT04961385 (Immunogenicity of the ChAdox1 n CoV-19 Vaccine Against SARS-CoV-2 With 12-dose Vials), which is not on this map. Cited by 915 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
915citing papers in PubMed, 1 pooled it
31.5field-weighted citation impact, top 1% 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.

NCT04961385 completednot on this map

Immunogenicity of the ChAdox1 n CoV-19 Vaccine Against SARS-CoV-2 With 12-dose Vials: an Interim Analysis

TypeobservationalSponsorBangkok Metropolitan Administration Medical College and Vajira HospitalRan2021 to 2021Enrolled60ConditionsCovid19, Vaccine, ImmunogenicityArmsImmunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine
3 · Its place in the literature

Who cites it

915 citing papers in PubMed, 1 synthesis or guideline pooled it, 1,398 citations in OpenAlex.

  1. Pooled it
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  15. The immunogenicity and safety of adenoviral-based vaccines.Current opinion in allergy and clinical immunology · 2026
    Review
  16. Article
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  19. Chemical reviews · 2026
    Review
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

65 authors at 7 institutions in 2 countries.

Maheshi N RamasamyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK. Electronic address: maheshi.ramasamy@paediatrics.ox.ac.uk.
Angela M MinassianThe Jenner Institute, University of Oxford, Oxford, UK.
Katie J EwerThe Jenner Institute, University of Oxford, Oxford, UK.
Amy L FlaxmanThe Jenner Institute, University of Oxford, Oxford, UK.
Pedro M FolegattiThe Jenner Institute, University of Oxford, Oxford, UK.
Daniel R OwensNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Merryn VoyseyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Parvinder K AleyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Brian AngusThe Jenner Institute, University of Oxford, Oxford, UK.
Gavin BabbageThe Jenner Institute, University of Oxford, Oxford, UK.
Sandra Belij-RammerstorferThe Jenner Institute, University of Oxford, Oxford, UK.
Lisa BerryNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Sagida BibiOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Mustapha BittayeThe Jenner Institute, University of Oxford, Oxford, UK.
Katrina CathiePaediatric Medicine, University of Southampton, Southampton, UK.
Harry ChappellNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Sue CharltonNational Infection Service, Public Health England, Porton Down, Salisbury, UK.
Paola CicconiThe Jenner Institute, University of Oxford, Oxford, UK.
Elizabeth A ClutterbuckOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Rachel Colin-JonesOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Christina DoldOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Katherine R W EmaryOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Sofiya FedosyukThe Jenner Institute, University of Oxford, Oxford, UK.
Michelle FuskovaThe Jenner Institute, University of Oxford, Oxford, UK.
Diane GbesemeteNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Catherine GreenClinical Biomanufacturing Facility, University of Oxford, Oxford, UK.
Bassam HallisNational Infection Service, Public Health England, Porton Down, Salisbury, UK.
Mimi M HouThe Jenner Institute, University of Oxford, Oxford, UK.
Daniel JenkinThe Jenner Institute, University of Oxford, Oxford, UK.
Carina C D JoeThe Jenner Institute, University of Oxford, Oxford, UK.
Elizabeth J KellyAstraZeneca BioPharmaceuticals Research and Development, Washington, DC, USA.
Simon KerridgeOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Alison M LawrieThe Jenner Institute, University of Oxford, Oxford, UK.
Alice LelliottOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
May N LwinNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Rebecca MakinsonThe Jenner Institute, University of Oxford, Oxford, UK.
Natalie G MarchevskyOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Yama MujadidiOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Alasdair P S MunroNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Mihaela PacurarNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Emma PlestedOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Jade RandNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Thomas RawlinsonThe Jenner Institute, University of Oxford, Oxford, UK.
Sarah RheadOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Hannah RobinsonNuffield Department of Medicine, and Oxford Centre for Clinical Tropical Medicine and Global Health, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Adam J RitchieThe Jenner Institute, University of Oxford, Oxford, UK.
Amy L Ross-RussellNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Stephen SaichNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Nisha SinghOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Catherine C SmithOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Matthew D SnapeOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Rinn SongOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; Division of Infectious Diseases, Boston Children's Hospital, Boston, MA, USA.
Richard TarrantClinical Biomanufacturing Facility, University of Oxford, Oxford, UK.
Yrene ThemistocleousThe Jenner Institute, University of Oxford, Oxford, UK.
Kelly M ThomasNational Infection Service, Public Health England, Porton Down, Salisbury, UK.
Tonya L VillafanaAstraZeneca BioPharmaceuticals Research and Development, Bethesda, MA, USA.
Sarah C WarrenNIHR Clinical Research Facility, University Hospital Southampton NHS Trust, Southampton, UK.
Marion E E WatsonThe Jenner Institute, University of Oxford, Oxford, UK.
Alexander D DouglasThe Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Adrian V S HillThe Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Teresa LambeThe Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Sarah C GilbertThe Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Saul N FaustNIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
Andrew J PollardOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Oxford COVID Vaccine Trial Group
University of Oxford · GBJenner Institute · GBUniversity Hospital Southampton NHS Foundation Trust · GBNIHR Southampton Biomedical Research Centre · GBPublic Health England · GBAstraZeneca (United States) · USUniversity of Southampton · GB

Funding

Medical Research Council MC_PC_19055Medical Research Council MR/T001151/1Wellcome Trust 109965/Z/15/Z
6 · The paper itself

Abstract

backgroundOlder adults (aged ≥70 years) are at increased risk of severe disease and death if they develop COVID-19 and are therefore a priority for immunisation should an efficacious vaccine be developed. Immunogenicity of vaccines is often worse in older adults as a result of immunosenescence. We have reported the immunogenicity of a novel chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19 (AZD1222), in young adults, and now describe the safety and immunogenicity of this vaccine in a wider range of participants, including adults aged 70 years and older.

methodsIn this report of the phase 2 component of a single-blind, randomised, controlled, phase 2/3 trial (COV002), healthy adults aged 18 years and older were enrolled at two UK clinical research facilities, in an age-escalation manner, into 18-55 years, 56-69 years, and 70 years and older immunogenicity subgroups. Participants were eligible if they did not have severe or uncontrolled medical comorbidities or a high frailty score (if aged ≥65 years). First, participants were recruited to a low-dose cohort, and within each age group, participants were randomly assigned to receive either intramuscular ChAdOx1 nCoV-19 (2·2 × 10

findingsBetween May 30 and Aug 8, 2020, 560 participants were enrolled: 160 aged 18-55 years (100 assigned to ChAdOx1 nCoV-19, 60 assigned to MenACWY), 160 aged 56-69 years (120 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY), and 240 aged 70 years and older (200 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY). Seven participants did not receive the boost dose of their assigned two-dose regimen, one participant received the incorrect vaccine, and three were excluded from immunogenicity analyses due to incorrectly labelled samples. 280 (50%) of 552 analysable participants were female. Local and systemic reactions were more common in participants given ChAdOx1 nCoV-19 than in those given the control vaccine, and similar in nature to those previously reported (injection-site pain, feeling feverish, muscle ache, headache), but were less common in older adults (aged ≥56 years) than younger adults. In those receiving two standard doses of ChAdOx1 nCoV-19, after the prime vaccination local reactions were reported in 43 (88%) of 49 participants in the 18-55 years group, 22 (73%) of 30 in the 56-69 years group, and 30 (61%) of 49 in the 70 years and older group, and systemic reactions in 42 (86%) participants in the 18-55 years group, 23 (77%) in the 56-69 years group, and 32 (65%) in the 70 years and older group. As of Oct 26, 2020, 13 serious adverse events occurred during the study period, none of which were considered to be related to either study vaccine. In participants who received two doses of vaccine, median anti-spike SARS-CoV-2 IgG responses 28 days after the boost dose were similar across the three age cohorts (standard-dose groups: 18-55 years, 20 713 arbitrary units [AU]/mL [IQR 13 898-33 550], n=39; 56-69 years, 16 170 AU/mL [10 233-40 353], n=26; and ≥70 years 17 561 AU/mL [9705-37 796], n=47; p=0·68). Neutralising antibody titres after a boost dose were similar across all age groups (median MNA

interpretationChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose. Further assessment of the efficacy of this vaccine is warranted in all age groups and individuals with comorbidities.

fundingUK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca.

Indexed as

Immunogenicity, VaccineAdolescentAdultAgedAged, 80 and overAge FactorsChAdOx1 nCoV-19COVID-19COVID-19 VaccinesFemaleHumansImmunization, SecondaryImmunoglobulin GMaleMiddle AgedSARS-CoV-2ChAdOx1 nCoV-19COVID-19 VaccinesImmunoglobulin G

Identifiers

PMID33220855
PMCPMC7674972
OpenAlexW3104989674

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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.