Evidence map›Paper›PMID 40686533›Full record

ArticleMayo Clinic proceedings. Innovations, quality & outcomes2025

Immunogenicity and Safety of ChAdOx1 nCoV-19 (AZD1222) as a Homologous Fourth-Dose Booster: A Substudy of the Phase 3 COV003 Trial in Brazil.

Sue Ann Costa Clemens, Sagida Bibi, Natalie G Marchevsky, Parvinder K Aley, Federica Cappuccini, Sophie A Davies, Isabela Gonzalez, Sarah C Kelly, Yama F Mujadidi, Eveline Pipolo Milan and 17 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Mayo Clinic proceedings. Innovations, quality & outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04536051 (A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT04536051 phase3unknown statusnot on this map

A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine

TypeinterventionalSponsorUniversity of OxfordRan2020 to 2021Enrolled10,300ConditionsCoronavirusArmsChAdOx1 nCoV-19 single dose + paracetamol, MenACWY single dose + paracetamol, ChAdOx1 nCoV-19 two dose + paracetamol, MenACWY prime & saline placebo boost + paracetamol
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Sue Ann Costa ClemensOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Sagida BibiOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Natalie G MarchevskyOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Parvinder K AleyOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Federica CappucciniOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Sophie A DaviesOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Isabela GonzalezInstitute for Global Health, University of Siena, Italy.
Sarah C KellyOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Yama F MujadidiOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Eveline Pipolo MilanCentro de Estudos e Pesquisas em Moléstias Infec, CePCLIN - Centro de Pesquisas Clínicas de Natal, Natal, Rio Grande do Norte, Brazil.
Alexandre V SchwarzboldClinical Research Unit, Department of Clinical Medicine, Universidade Federal de Santa Maria, Brazil.
Eduardo SprinzHospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Brazil.
Merryn VoyseyOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Lily Y WeckxDepartment of Pediatrics, Universidade Federal de São Paulo, Brazil.
Daniel WrightOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Himanshu BansalBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.
Maria A S BergagårdClinical Operations, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Abby J IsaacsBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.
Elizabeth J KellyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.
Dongmei LanBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.
Shethah MorganClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
Nirmal Kumar ShankarPatient Safety, Vaccines & Immune Therapies, BioPharmaceuticals, AstraZeneca, Bangalore, India.
Kathryn ShoemakerOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Tonya L VillafanaClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.
Teresa LambeOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.
Justin A GreenClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
Andrew J PollardOxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, United Kingdom.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To address that, despite widespread use of ChAdOx1 nCoV-19 (AZD1222) as a COVID-2019 booster, fourth-dose clinical outcomes data are limited. We report immunogenicity and safety for ChAdOx1 nCoV-19 as a homologous fourth-dose booster. Participants and Methods: Participants (aged ≥18 years) who had received 2 doses of ChAdOx1 nCoV-19 in phase 3 COV003 trial in Brazil were offered a third dose after a planned dose interval from 11 to 13 months and a fourth dose after a planned interval from 6 to 15 months (both 5 × 10 Results: 172 participants received a fourth dose (median interval postthird dose, 10.7 months). Ancestral SARS-CoV-2-neutralizing antibody titers postdose 4 were noninferior to those postdose 3; geometric mean fold rise was 1.9 (95% CI, 1.6-2.4; n=112). Immunogenicity results were consistent across all variants analyzed. Local and systemic solicited adverse events were reported in 60.3% (n=35/58) and 43.1% (n=25/58) of participants, respectively. Conclusion: Immune responses after a fourth dose of ChAdOx1 nCoV-19 were noninferior to those after a third dose across SARS-CoV-2 variants. The fourth dose was well tolerated with no emergent safety concerns, supporting the continued development of the ChAdOx1 platform in preparation for future pandemics. Trial Registration: clinicaltrials.gov Identifier: NCT04536051.

Identifiers

PMID40686533
PMCPMC12275839

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Registered trials

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