Evidence map›Paper›PMID 35441174›Full record

ArticlemedRxiv : the preprint server for health sciences2022

Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 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

Abstract readPreprint
PubMed Full text at PMC Publisher
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

61 authors.

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.
David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
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.
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.
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.
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.
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, RJ, 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, RJ, Brazil.
Rebone MaboaNdlovu Elandsdoorn Site, Limpopo, Dennilton, South Africa.
April K RandhawaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
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.
Hanneke SchuitemakerJanssen Vaccines and Prevention, Leiden, the Netherlands.
Macaya DouoguihJanssen Vaccines and Prevention, Leiden, the Netherlands.
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.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Lindsay N CarppVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Dean FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Richard A KoupVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Ruben O DonisBiomedical Advanced Research and Development Authority, Washington, DC, USA.
Janssen Team
Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team
United States Government (USG)/CoVPN Biostatistics Team

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
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)U01AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI GRINSZTEJN, BEATRIZ · 2008 to 2011
$14.0M
COVID-19 Clinical Support and ResearchZIAAI005159 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MCDERMOTT, ADRIAN · 2020 to 2022
$8.9M
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
PPE RequestS10AI174104 · NIAID · FRED HUTCHINSON CANCER CENTER · PI COREY, LAWRENCE · 2023 to 2023
$1.4M
CLC NIH HHS C0000008NIAID NIH HHS R37 AI054165NIAID NIH HHS S10 AI174104NIAID NIH HHS U01 AI069476NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069476NIH HHS S10 OD028685
6 · The paper itself

Abstract

Anti-spike IgG binding antibody, anti-receptor binding domain IgG antibody, and pseudovirus neutralizing antibody measurements four weeks post-vaccination were assessed as correlates of risk of moderate to severe-critical COVID-19 outcomes through 83 days post-vaccination and as correlates of protection following a single dose of Ad26.COV2.S COVID-19 vaccine in the placebo-controlled phase of ENSEMBLE, an international, randomized efficacy trial. Each marker had evidence as a correlate of risk and of protection, with strongest evidence for 50% inhibitory dilution (ID50) neutralizing antibody titer. The outcome hazard ratio was 0.49 (95% confidence interval 0.29, 0.81; p=0.006) per 10-fold increase in ID50; vaccine efficacy was 60% (43, 72%) at nonquantifiable ID50 (< 2.7 IU50/ml) and rose to 89% (78, 96%) at ID50 = 96.3 IU50/ml. Comparison of the vaccine efficacy by ID50 titer curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine, and the COV002-UK trial of the AZD1222 vaccine supported consistency of the ID50 titer correlate of protection across trials and vaccine types.

Identifiers

PMID35441174
PMCPMC9016647

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.