Trial reportNature communications2024
Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial.
Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04505722 (A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.
0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.
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.
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Neutralising antibodies and protection from progression to severe COVID-19: A meta-analysis.PLoS medicine · 2026Pooled it
- Vaccine-induced T cell responses correlate with reduced risk of severe COVID-19 in a placebo-controlled efficacy trial.EBioMedicine · 2025Trial
- Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial.Nature communications · 2024Trial
- Monoclonal antibody CIS43LS sets the bar for long-acting malaria protection.The Journal of clinical investigation · 2026Article
- Recent advances in HIV-1 envelope-based vaccine designs for guiding broadly neutralizing antibody response.Journal of virology · 2026Review
- Article
- Analysis of Antibody Markers as Immune Correlates of Risk of Severe COVID-19 in the PREVENT-19 Efficacy Trial of the NVX-CoV2373 Recombinant Protein Vaccine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Correlates of severe and delta COVID-19 in a phase 3 trial of the AZD1222 vaccine.NPJ vaccines · 2026Article
- SARS-CoV-2 vaccination and infection elicit cross-neutralizing responses against clade 3 and 4 sarbecoviruses.Nature communications · 2026Article
- Humoral and cellular immune response after COVID-19 vaccination in patients with sickle cell disease on hydroxyurea.Blood advances · 2026Article
- COVID-19 vaccination in pregnancy: efficacy of second-generation vaccines, maternal-neonatal safety, and strategies to address vaccine hesitancy.Frontiers in medicine · 2026Review
- SARS-CoV-2 neutralising antibody profiles reveal variant specific antibody dynamics and regional differences in infection histories in Malawi.PLOS global public health · 2026Article
- Exploring the standardization of human nasal antibody measurements.Emerging microbes & infections · 2025Article
- Prospective SARS-CoV-2 additional vaccination in immunosuppressant-treated individuals with autoimmune diseases in a randomized controlled trial.JCI insight · 2025Article
- Immune correlates analysis of antibody responses against SARS-CoV-2 variants in the ENSEMBLE vaccine efficacy trial.iScience · 2025Article
- Strong immunogenicity and protection against SARS-CoV-2 in hamsters induced by heterologous boost vaccination with an MVA-based COVID-19 vaccine candidate.The Journal of general virology · 2025Article
- Neutralizing and binding antibodies are a correlate of risk of COVID-19 in the CoVPN 3008 study in people with HIV.Nature communications · 2025Article
- Article
- T-Cell Epitope-Based SARS-CoV-2 DNA Vaccine Encoding an Antigen Fused with Type 1 Herpes Simplex Virus Glycoprotein D (gD).Viruses · 2025Article
- Recurrent waning of anti-SARS-CoV-2 neutralizing antibodies despite multiple antigen encounters.Journal of translational medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
61 authors.
Lindsay N Carpp *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-0333-5925
Ollivier Hyrien *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Youyi Fong *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
David BenkeserDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.ORCID 0000-0002-1019-8343
Sanne RoelsJohnson & Johnson Innovative Medicine, Beerse, Belgium.
Daniel J StiehJanssen Vaccines and Prevention, Leiden, the Netherlands.ORCID 0009-0003-8523-1528
Ilse Van DrommeJohnson & Johnson Innovative Medicine, Beerse, Belgium.
Griet A Van RoeyJanssen Vaccines and Prevention, Leiden, the Netherlands.
Avi KennyDepartment of Biostatistics, University of Washington School of Public Health, Seattle, WA, USA.
Ying HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-9655-7502
Marco CaroneDepartment of Biostatistics, University of Washington School of Public Health, Seattle, WA, USA.ORCID 0000-0003-2106-0953
Adrian B McDermottVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID 0000-0003-0616-9117
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 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 0000-0001-5496-8090
Alex LuedtkeDepartment of Statistics, University of Washington, 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.
Michal JuraskaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-0920-2915
Nima S HejaziVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-7127-2789
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.ORCID 0000-0001-8441-5737
Linda-Gail BekkerInstitute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, Cape Town, South Africa.ORCID 0000-0002-0755-4386
Aditya H GaurDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.ORCID 0000-0002-6639-5231
Valdilea G VelosoEvandro Chagas National Institute of Infectious Diseases-Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
April K RandhawaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 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 TruyersJohnson & Johnson Innovative Medicine, Beerse, Belgium.
An VandeboschJohnson & Johnson Innovative Medicine, Beerse, Belgium.
Frank StruyfJohnson & Johnson Innovative Medicine, Beerse, Belgium.ORCID 0000-0001-9988-0260
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.ORCID 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.ORCID 0000-0003-4073-0393
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.ORCID 0000-0001-6137-8312
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA. pgilbert@fredhutch.org.ORCID 0000-0002-2662-9427
Immune Assays 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
$1175.6MSDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9MThe FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3MStatistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7MHigh-Performance Compute Cluster for Comprehensive Cancer and Infectious Diseases ResearchS10OD028685 · OD · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BRADLEY, PHILIP · 2020 to 2020
$2.0MCLC NIH HHS C0000008NIAID NIH HHS R37 AI054165NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069476NIH HHS S10 OD028685
Abstract
Assessment of immune correlates of severe COVID-19 has been hampered by the low numbers of severe cases in COVID-19 vaccine efficacy (VE) trials. We assess neutralizing and binding antibody levels at 4 weeks post-Ad26.COV2.S vaccination as correlates of risk and of protection against severe-critical COVID-19 through 220 days post-vaccination in the ENSEMBLE trial (NCT04505722), constituting ~4.5 months longer follow-up than our previous correlates analysis and enabling inclusion of 42 severe-critical vaccine-breakthrough cases. Neutralizing antibody titer is a strong inverse correlate of severe-critical COVID-19, with estimated hazard ratio (HR) per 10-fold increase 0.35 (95% CI: 0.13, 0.90). In a multivariable model, HRs are 0.31 (0.11, 0.89) for neutralizing antibody titer and 1.22 (0.49, 3.02) for anti-Spike binding antibody concentration. VE against severe-critical COVID-19 rises with neutralizing antibody titer: 63.1% (95% CI: 40.0%, 77.3%) at unquantifiable [<4.8975 International Units (IU)50/ml], 85.2% (47.2%, 95.3%) at just-quantifiable (5.2 IU50/ml), and 95.1% (81.1%, 96.9%) at 90
Indexed as
Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesSARS-CoV-2Ad26COVS1AdultAgedFemaleHumansMaleMiddle AgedSpike Glycoprotein, CoronavirusVaccinationVaccine EfficacyAd26COVS1Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesSpike Glycoprotein, Coronavirus
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What OpenQuestion holds
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LicenceCC BY
Read underepoch 390
Registered trials
NCT04505722ClinicalTrials.gov
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.