Evidence map›Paper›PMID 41137757›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

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.

Youyi Fong, Yunda Huang, Ying Huang, Wayne Woo, Alice McGarry, Germán Áñez, Lisa M Dunkle, Iksung Cho, Christopher R Houchens, Karen Martins and 32 more

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

42 authors.

Youyi FongVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0002-4230-6863
Yunda HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Ying HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Wayne WooDepartment of Biostatistics, Novavax, Inc., Gaithersburg, Maryland, USA.
Alice McGarryDepartment of Biostatistics, Novavax, Inc., Gaithersburg, Maryland, USA.
Germán ÁñezDepartment of Biostatistics, Novavax, Inc., Gaithersburg, Maryland, USA.ORCID 0000-0001-5361-3001
Lisa M DunkleDepartment of Biostatistics, Novavax, Inc., Gaithersburg, Maryland, USA.
Iksung ChoDepartment of Biostatistics, Novavax, Inc., Gaithersburg, Maryland, USA.
Christopher R HouchensBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC, USA.
Karen MartinsBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC, USA.
Lakshmi JayashankarBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC, USA.
Flora CastellinoBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC, USA.
Christos J PetropoulosLabCorp-Monogram Biosciences, South San Francisco, California, USA.
Andrew LeithNexelis, Seattle, Washington, USA.
Deanne HaugaardNexelis, Seattle, Washington, USA.
William WebbNexelis, Seattle, Washington, USA.
Yiwen LuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Chenchen YuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Lindsay N CarppVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0003-0333-5925
April K RandhawaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0003-2652-3734
Michele P AndrasikVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Julia HutterDivision of AIDS, National Institute of Allergy and Infectious Diseases, NIH, Rockville, Maryland, USA.
Maryam Keshtkar-JahromiDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, Rockville, Maryland, USA.
Tatiana H BeresnevDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, Rockville, Maryland, USA.
Carina A RodriguezDivision of Pediatric Infectious Diseases, University of South Florida, Morsani College of Medicine, Tampa, Florida, USA.ORCID 0000-0001-8687-9703
Milagritos TapiaCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-6476-3934
Christine B TurleyAtrium Health Wake Forest School of Medicine, Charlotte, North Carolina, USA.ORCID 0000-0001-8079-9382
Carmen D ZorrillaObstetrics and Gynecology Department, School of Medicine, University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico.ORCID 0000-0001-7740-1636
Stuart H CohenDepartment of Internal Medicine, Division of Infectious Diseases, Sacramento, University of California Davis Medical Center, California, USA.
Susan E KlineDepartment of Medicine, Division of Infectious Diseases and International Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Elizabeth BarrancoDepartment of Internal Medicine, Ponce Health Sciences University, Ponce, Puerto Rico.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-9480-2714
Dean FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Julie A AkeU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.ORCID 0000-0003-3831-5828
Cynthia L GayDivision of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.ORCID 0000-0002-3620-3059
Karen L KotloffCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Thomas JonesBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC, USA.
Richard A KoupVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Ruben O DonisBiomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, Washington, DC, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0002-2662-9427

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
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
Administration for Strategic Preparedness and ResponseAIDS Clinical Trials Group Leadership and Operations Center UM1 AI68636Biomedical Advanced Research and Development Authority 75A50123D00005CLC NIH HHS C0000008HHSHIV Prevention Trials Network Leadership and Operations Center UM1 AI68619HIV Vaccine Trials NetworkHVTN Laboratory Center UM1 AI68618HVTN Statistics and Data Management Center UM1 AI68635Intramural Research Program of NIAIDNational Institute of Allergy and Infectious Diseases R37AI054165NIAID NIH HHS R37 AI054165NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI148684NIH HHSNIH HHS S10 OD028685NIH Public Access PolicyNovavaxOperations Center UM1 AI68614Scientific Computing Infrastructure at Fred Hutch S10OD028685U.S. Department of Defense 75A50122C00008U.S. Department of Defense 75A50122C00013U.S. Department of Defense W911QY20C0077
6 · The paper itself

Abstract

backgroundWe previously showed that ancestral-specific anti-Spike binding IgG concentration and 50% inhibitory dilution neutralizing antibody titer (nAb-ID50) measured at 2 weeks postdose 2 (∼peak) were inverse correlates of risk (CoRs) of COVID-19 over 2 months post ∼peak in the PREVENT-19 trial of the NVX-CoV2373 vaccine; there were not sufficient data to assess CoRs of severe COVID-19.

methodsHere, we assessed, in the same vaccinated cohort, Delta- and ancestral-specific Spike IgG and nAb-ID50 at ∼peak and over time as CoRs of severe COVID-19 and of Delta COVID-19 over 3.5-10 months post ∼peak (287 breakthrough Delta cases, including 8 severe; 446 noncases).

resultsPeak antibody levels were much higher for noncases versus severe cases (all inferred Delta), with nAb-ID50 Delta geometric mean 209.5 arbitrary units (AU)/mL (95% CI: 176.1, 249.1) versus 9.6 AU/mL (95% CI: 2.4, 38.6), respectively. Frequency of detectable nAb-ID50 titer was 98.3% (97.2, 99.0) for noncases versus 62.5% (22.3, 93.9) for severe cases. All markers were inverse CoRs of severe COVID-19, with a ∼peak hazard ratio (HR) of 0.13 (95% CI: .03, .57) per 10-fold nAb-ID50 Delta increase. Severe COVID-19 risk through 305 days postday 35 was 0.0338 (0.0043, 0.206) at the nAb-ID50 Delta 2.5th percentile (8.4 AU/mL), and 0.002 (0.0000, 0.0108) and 0.0002 (0.0000, 0.0035) at the 50th and 95th percentiles (210, 2522 AU/mL).

conclusionsPostvaccination NVX-CoV2373 antibody levels are stronger predictors of severe COVID-19 than any-severity Delta COVID-19. Low antibody responses indicate vulnerability to severe COVID-19.

Indexed as

Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesSARS-CoV-2AdultBiomarkersFemaleHumansImmunoglobulin GMaleMiddle AgedSeverity of Illness IndexSpike Glycoprotein, CoronavirusVaccines, SyntheticAntibodies, NeutralizingAntibodies, ViralBiomarkersCOVID-19 VaccinesImmunoglobulin GNVX-CoV2373 adjuvated lipid nanoparticleSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2Vaccines, Syntheticcase-cohort samplingCOVID-19 vaccine efficacy trialexposure-proximal immune correlates analysisneutralizing antibodiessevere COVID-19

Identifiers

PMID41137757
PMCPMC12611457

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.