Evidence map›Paper›PMID 36357712›Full record

Trial reportNature microbiology2022

Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial.

Youyi Fong, Adrian B McDermott, David Benkeser, Sanne Roels, Daniel J Stieh, An Vandebosch, Mathieu Le Gars, Griet A Van Roey, Christopher R Houchens, Karen Martins and 51 more

Open access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Nature microbiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 2 pooled it
8.8field-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.

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

67 citing papers in PubMed, 2 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. 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
  7. Trial
  8. Trial
  9. 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
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Review
  16. Cytomegalovirus Vaccines in Transplantation: History, Hurdles, and Hope.Transplant infectious disease : an official journal of the Transplantation Society · 2026
    Review
  17. Article
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

61 authors at 16 institutions in 5 countries.

Youyi FongVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Adrian B McDermottVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0003-0616-9117
David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-1019-8343
Sanne RoelsJanssen R&D, a division of Janssen Pharmaceutica NV, Beerse, Belgium.
Daniel J StiehJanssen Vaccines and Prevention, Leiden, the Netherlands.
An VandeboschJanssen R&D, a division of Janssen Pharmaceutica NV, Beerse, Belgium.
Mathieu Le GarsJanssen Vaccines and Prevention, Leiden, the Netherlands.
Griet A Van RoeyJanssen Vaccines and Prevention, Leiden, the Netherlands.
Christopher R HouchensBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Karen MartinsBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Lakshmi JayashankarBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Flora CastellinoBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Obrimpong Amoa-AwuaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Manjula BasappaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Britta FlachVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Bob C LinVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Christopher MooreVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Mursal NaisanVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Muhammed NaqviVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Sandeep NarpalaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Sarah O'ConnellVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Allen MuellerVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Leo SerebryannyyVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Mike CastroVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-8045-1754
Jennifer WangVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Christos J PetropoulosLabCorp-Monogram Biosciences, South San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-5496-8090
Alex LuedtkeDepartment of Statistics, University of Washington, Seattle, WA, USA.
Ollivier HyrienVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, 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
Avi KennyDepartment of Biostatistics, University of Washington School of Public Health, Seattle, WA, USA.
Marco CaroneDepartment of Biostatistics, University of Washington School of Public Health, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-2106-0953
Daniel N WolfeBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Jerald SadoffJanssen Vaccines and Prevention, Leiden, the Netherlands.
Glenda E GrayPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Beatriz GrinsztejnEvandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
Paul A GoepfertDivision of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Susan J LittleDivision of Infectious Diseases, University of California San Diego, La Jolla, CA, USA.
Leonardo Paiva de SousaEvandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.ORCID http://orcid.org/0000-0001-9004-5154
Rebone MaboaNdlovu Elandsdoorn Site, Dennilton, Limpopo, South Africa.
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.
Jenny HendriksJanssen Vaccines and Prevention, Leiden, the Netherlands.
Carla TruyersJanssen R&D, a division of Janssen Pharmaceutica NV, Beerse, Belgium.
Frank StruyfJanssen R&D, a division of Janssen Pharmaceutica NV, Beerse, Belgium.ORCID http://orcid.org/0000-0001-9988-0260
Hanneke SchuitemakerJanssen Vaccines and Prevention, Leiden, the Netherlands.ORCID http://orcid.org/0000-0001-8563-2266
Macaya DouoguihJanssen Vaccines and Prevention, Leiden, the Netherlands.ORCID http://orcid.org/0000-0002-2707-5729
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, 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.ORCID http://orcid.org/0000-0001-9480-2714
Lindsay N CarppVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-0333-5925
Dean FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0003-4073-0393
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
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, Washington, DC, USA.
Immune Assays Team
Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team
and the United States Government (USG)/CoVPN Biostatistics Team
National Institutes of Health · USFred Hutch Cancer Center · USJanssen (Netherlands) · NLBiomedical Advanced Research and Development Authority · USUniversity of Washington · USJanssen (Belgium) · BEFundação Oswaldo Cruz · BRCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZACornell University · USEmory University · USLabCorp (United States) · USSouth African Medical Research Council · ZAUniversity of Alabama at Birmingham · USUniversity of California San Diego · USUniversity of Limpopo · ZAUniversity of Maryland, Baltimore · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
High-Performance Compute Cluster for Comprehensive Cancer and Infectious Diseases ResearchS10OD028685 · OD · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BRADLEY, PHILIP · 2020 to 2020
$2.0M
ASPR HHS HHSO100201700018CCLC NIH HHS C0000008NIAID NIH HHS R37 AI054165NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635NIH HHS S10 OD028685
6 · The paper itself

Abstract

Measuring immune correlates of disease acquisition and protection in the context of a clinical trial is a prerequisite for improved vaccine design. We analysed binding and neutralizing antibody measurements 4 weeks post vaccination as correlates of risk of moderate to severe-critical COVID-19 through 83 d post vaccination in the phase 3, double-blind placebo-controlled phase of ENSEMBLE, an international randomized efficacy trial of a single dose of Ad26.COV2.S. We also evaluated correlates of protection in the trial cohort. Of the three antibody immune markers we measured, we found most support for 50% inhibitory dilution (ID

Indexed as

Ad26COVS1COVID-192019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingChAdOx1 nCoV-19HumansVaccine Efficacy2019-nCoV Vaccine mRNA-1273Ad26COVS1Antibodies, NeutralizingChAdOx1 nCoV-19

Identifiers

PMID36357712
PMCPMC10166187
OpenAlexW4308774038

What OpenQuestion holds

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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.