Evidence map›Paper›PMID 36899062›Full record

ArticleNPJ vaccines2023

Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine.

David Benkeser, Youyi Fong, Holly E Janes, Elizabeth J Kelly, Ian Hirsch, Stephanie Sproule, Ann Marie Stanley, Jill Maaske, Tonya Villafana, Christopher R Houchens and 33 more

Open access · goldFull text read
In one paragraph

Article in NPJ vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
7.6field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Neutralizing Antibody Immune Correlates for a Recombinant Protein Vaccine in the COVAIL Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
  6. Trial
  7. Stochastic interventional approach to assessing immune correlates of protection: Application to the COVE messenger RNA-1273 vaccine trial.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2023
    Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

43 authors at 16 institutions in 3 countries.

David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
Youyi FongVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Holly E JanesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Elizabeth J KellyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Ian HirschBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.
Stephanie SprouleBiometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Ann Marie StanleyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0002-0588-8681
Jill MaaskeClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Tonya VillafanaClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Christopher R HouchensBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
Karen MartinsBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
Lakshmi JayashankarBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
Flora CastellinoBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
Victor AyalaBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
Christos J PetropoulosLabCorp-Monogram Biosciences, South San Francisco, CA, USA.
Andrew LeithNexelis, Seattle, WA, USA.
Deanne HaugaardNexelis, Seattle, WA, USA.
Bill WebbNexelis, Seattle, WA, USA.
Yiwen LuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Chenchen YuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Bhavesh BorateVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Lars W P van der LaanVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Nima S HejaziVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0002-7127-2789
Lindsay N CarppVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-0333-5925
April K RandhawaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-2652-3734
Michele P AndrasikVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-1279-3741
Margaret Brewinski IsaacsDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Mamodikoe MakheneDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Tina TongVaccine Translational Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Merlin L RobbUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0003-3949-9649
Lawrence CoreyDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-2179-2436
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Dean FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Corey HoffmanBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
Ann R FalseyDivision of Infectious Diseases, Department of Medicine, University of Rochester, Rochester, NY, USA.
Magdalena SobieszczykDivision of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, NY, USA.
Richard A Koup *Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Ruben O Donis *Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.ORCID http://orcid.org/0000-0001-6137-8312
Peter B Gilbert *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA. pgilbert@fredhutch.org.ORCID http://orcid.org/0000-0002-2662-9427
AstraZeneca AZD1222 Clinical Study Group
Immune Assays Team
United States Government (USG)/CoVPN Biostatistics Team
Fred Hutch Cancer Center · USBiomedical Advanced Research and Development Authority · USAstraZeneca (United States) · USNational Institutes of Health · USExelis (United States) · USEmory University · USAstraZeneca (United Kingdom) · GBCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZAHarvard University · USLabCorp (United States) · USNational Institute of Allergy and Infectious Diseases · USNewYork–Presbyterian Hospital · USUniversity of Maryland, Baltimore · USUniversity of Rochester · USUniversity of Washington · 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
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
Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
CLC NIH HHS C0000008NIAID NIH HHS R37 AI054165NIAID 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 AI148372NIAID NIH HHS UM1 AI148450NIAID NIH HHS UM1 AI148574NIAID NIH HHS UM1 AI148684NIH HHS S10 OD028685
6 · The paper itself

Abstract

In the phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine conducted in the U.S., Chile, and Peru, anti-spike binding IgG concentration (spike IgG) and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured four weeks after two doses were assessed as correlates of risk and protection against PCR-confirmed symptomatic SARS-CoV-2 infection (COVID-19). These analyses of SARS-CoV-2 negative participants were based on case-cohort sampling of vaccine recipients (33 COVID-19 cases by 4 months post dose two, 463 non-cases). The adjusted hazard ratio of COVID-19 was 0.32 (95% CI: 0.14, 0.76) per 10-fold increase in spike IgG concentration and 0.28 (0.10, 0.77) per 10-fold increase in nAb ID50 titer. At nAb ID50 below the limit of detection (< 2.612 IU50/ml), 10, 100, and 270 IU50/ml, vaccine efficacy was -5.8% (-651%, 75.6%), 64.9% (56.4%, 86.9%), 90.0% (55.8%, 97.6%) and 94.2% (69.4%, 99.1%). These findings provide further evidence towards defining an immune marker correlate of protection to help guide regulatory/approval decisions for COVID-19 vaccines.

Identifiers

PMID36899062
PMCPMC10005913
OpenAlexW4323921279

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read97
identifiers read1
Read underepoch 390

Registered trials

None linked

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.