Evidence map›Paper›PMID 36713413›Full record

Trial reportFrontiers in immunology2022

Robust humoral and cellular recall responses to AZD1222 attenuate breakthrough SARS-CoV-2 infection compared to unvaccinated.

Jill Maaske, Stephanie Sproule, Ann R Falsey, Magdalena E Sobieszczyk, Anne F Luetkemeyer, Grant C Paulsen, Sharon A Riddler, Merlin L Robb, Charlotte-Paige Rolle, Beverly E Sha and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04516746 (A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.5field-weighted citation impact, top 11% 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.

NCT04516746 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

TypeinterventionalSponsorAstraZenecaRan2020 to 2023Enrolled32,450ConditionsCOVID-19, SARS-CoV-2ArmsAZD1222, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. The characterization of CD8Emerging microbes & infections · 2024
    Review
  5. Review
  6. Article
  7. Article
  8. Construction and application of adenoviral vectors.Molecular therapy. Nucleic acids · 2023
    Review
  9. Article
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

25 authors at 11 institutions in 2 countries.

Jill MaaskeClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Stephanie SprouleBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Ann R FalseyUniversity of Rochester School of Medicine and Dentistry, Rochester, NY, United States.
Magdalena E SobieszczykDivision of Infectious Diseases, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian Columbia University Irving Medical Center, New York, NY, United States.
Anne F LuetkemeyerZuckerberg San Francisco General, University of California, San Francisco, San Francisco, CA, United States.
Grant C PaulsenDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States.
Sharon A RiddlerDivision of Infectious Diseases, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.
Merlin L RobbWalter Reed Army Institute of Research, Silver Spring, MD, United States.
Charlotte-Paige RolleOrlando Immunology Center, Orlando, FL, United States.
Beverly E ShaDivision of Infectious Diseases, Department of Internal Medicine, Rush University Medical Center, Chicago, IL, United States.
Tina TongNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States.
Bahar AhaniBioinformatics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Anastasia A AksyukTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Himanshu BansalBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Timothy EganBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Brett JepsonBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Marcelino PadillaTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Nirmeshkumar PatelBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Kathryn ShoemakerBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Ann Marie StanleyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Phillip A SwansonTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Deidre WilkinsTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Tonya VillafanaClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
Justin A GreenClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
Elizabeth J KellyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, United States.
AstraZeneca (United States) · USAstraZeneca (United Kingdom) · GBCincinnati Children's Hospital Medical Center · USColumbia University · USNational Institutes of Health · USOrlando Immunology Center · USRush University Medical Center · USUnity Health System · USUniversity of California, San Francisco · USUniversity of Pittsburgh · USWalter Reed Army Institute of Research · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) - DMID 21-0012UM1AI148574 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Angelica Cifuentes Kottkamp, Anoma Nellore · 2020 to 2026
$23.9M
University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric StudyUM1AI148450 · NIAID · UNIVERSITY OF ROCHESTER · PI Angela Ramona Branche, Ann R Falsey · 2020 to 2026
$20.6M
Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) - Moderna Pediatric StudyUM1AI148372 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Robert Wilson Frenck · 2020 to 2026
$20.5M
Columbia Collaborative HIV/AIDS Clinical Trials UnitU01AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HAMMER, SCOTT M · 2007 to 2011
$15.4M
NIAID NIH HHS U01 AI069470NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI148372NIAID NIH HHS UM1 AI148450NIAID NIH HHS UM1 AI148574NIAID NIH HHS UM1 AI148684
6 · The paper itself

Abstract

Background: Breakthrough severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in coronavirus disease 2019 (COVID-19) vaccinees typically produces milder disease than infection in unvaccinated individuals. Methods: To explore disease attenuation, we examined COVID-19 symptom burden and immuno-virologic responses to symptomatic SARS-CoV-2 infection in participants (AZD1222: n=177/17,617; placebo: n=203/8,528) from a 2:1 randomized, placebo-controlled, phase 3 study of two-dose primary series AZD1222 (ChAdOx1 nCoV-19) vaccination (NCT04516746). Results: We observed that AZD1222 vaccinees had an overall lower incidence and shorter duration of COVID-19 symptoms compared with placebo recipients, as well as lower SARS-CoV-2 viral loads and a shorter median duration of viral shedding in saliva. Vaccinees demonstrated a robust antibody recall response versus placebo recipients with low-to-moderate inverse correlations with virologic endpoints. Vaccinees also demonstrated an enriched polyfunctional spike-specific Th-1-biased CD4+ and CD8+ T-cell response that was associated with strong inverse correlations with virologic endpoints. Conclusion: Robust immune responses following AZD1222 vaccination attenuate COVID-19 disease severity and restrict SARS-CoV-2 transmission potential by reducing viral loads and the duration of viral shedding in saliva. Collectively, these analyses underscore the essential role of vaccination in mitigating the COVID-19 pandemic.

Indexed as

ChAdOx1 nCoV-19COVID-19Breakthrough InfectionsCD8-Positive T-LymphocytesHumansImmunity, CellularImmunity, HumoralPandemicsSARS-CoV-2ChAdOx1 nCoV-19AZD1222 (ChAdOx1 nCoV-19)breakthrough infectioncell-mediated immunityCOVID-19 vaccineSARS-CoV-2serology

Identifiers

PMID36713413
PMCPMC9881590
OpenAlexW4315874754

What OpenQuestion holds

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LicenceCC BY
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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.