IDEAS home Printed from https://ideas.repec.org/a/nat/natcom/v14y2023i1d10.1038_s41467-022-35768-3.html
   My bibliography  Save this article

Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Listed:
  • Youyi Fong

    (Fred Hutchinson Cancer Center
    Fred Hutchinson Cancer Center)

  • Yunda Huang

    (Fred Hutchinson Cancer Center
    University of Washington)

  • David Benkeser

    (Emory University)

  • Lindsay N. Carpp

    (Fred Hutchinson Cancer Center)

  • Germán Áñez

    (Novavax, Inc.)

  • Wayne Woo

    (Novavax, Inc.)

  • Alice McGarry

    (Novavax, Inc.)

  • Lisa M. Dunkle

    (Novavax, Inc.)

  • Iksung Cho

    (Novavax, Inc.)

  • Christopher R. Houchens

    (Biomedical Advanced Research and Development Authority)

  • Karen Martins

    (Biomedical Advanced Research and Development Authority)

  • Lakshmi Jayashankar

    (Biomedical Advanced Research and Development Authority)

  • Flora Castellino

    (Biomedical Advanced Research and Development Authority)

  • Christos J. Petropoulos

    (LabCorp-Monogram Biosciences)

  • Andrew Leith

    (Nexelis)

  • Deanne Haugaard

    (Nexelis)

  • Bill Webb

    (Nexelis)

  • Yiwen Lu

    (Fred Hutchinson Cancer Center)

  • Chenchen Yu

    (Fred Hutchinson Cancer Center)

  • Bhavesh Borate

    (Fred Hutchinson Cancer Center)

  • Lars W. P. van der Laan

    (Fred Hutchinson Cancer Center
    University of Washington)

  • Nima S. Hejazi

    (Fred Hutchinson Cancer Center
    Harvard University)

  • April K. Randhawa

    (Fred Hutchinson Cancer Center)

  • Michele P. Andrasik

    (Fred Hutchinson Cancer Center)

  • James G. Kublin

    (Fred Hutchinson Cancer Center)

  • Julia Hutter

    (National Institute of Allergy and Infectious Diseases, NIH)

  • Maryam Keshtkar-Jahromi

    (National Institute of Allergy and Infectious Diseases, NIH)

  • Tatiana H. Beresnev

    (National Institute of Allergy and Infectious Diseases, NIH)

  • Lawrence Corey

    (Fred Hutchinson Cancer Center
    University of Washington)

  • Kathleen M. Neuzil

    (University of Maryland School of Medicine)

  • Dean Follmann

    (National Institutes of Health)

  • Julie A. Ake

    (Walter Reed Army Institute of Research)

  • Cynthia L. Gay

    (University of North Carolina School of Medicine)

  • Karen L. Kotloff

    (University of Maryland School of Medicine)

  • Richard A. Koup

    (National Institutes of Health)

  • Ruben O. Donis

    (Biomedical Advanced Research and Development Authority)

  • Peter B. Gilbert

    (Fred Hutchinson Cancer Center
    Fred Hutchinson Cancer Center
    University of Washington)

Abstract

In the PREVENT-19 phase 3 trial of the NVX-CoV2373 vaccine (NCT04611802), anti-spike binding IgG concentration (spike IgG), anti-RBD binding IgG concentration (RBD IgG), and pseudovirus 50% neutralizing antibody titer (nAb ID50) measured two weeks post-dose two are assessed as correlates of risk and as correlates of protection against COVID-19. Analyses are conducted in the U.S. cohort of baseline SARS-CoV-2 negative per-protocol participants using a case-cohort design that measures the markers from all 12 vaccine recipient breakthrough COVID-19 cases starting 7 days post antibody measurement and from 639 vaccine recipient non-cases. All markers are inversely associated with COVID-19 risk and directly associated with vaccine efficacy. In vaccine recipients with nAb ID50 titers of 50, 100, and 7230 international units (IU50)/ml, vaccine efficacy estimates are 75.7% (49.8%, 93.2%), 81.7% (66.3%, 93.2%), and 96.8% (88.3%, 99.3%). The results support potential cross-vaccine platform applications of these markers for guiding decisions about vaccine approval and use.

Suggested Citation

  • Youyi Fong & Yunda Huang & David Benkeser & Lindsay N. Carpp & Germán Áñez & Wayne Woo & Alice McGarry & Lisa M. Dunkle & Iksung Cho & Christopher R. Houchens & Karen Martins & Lakshmi Jayashankar & F, 2023. "Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial," Nature Communications, Nature, vol. 14(1), pages 1-15, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-022-35768-3
    DOI: 10.1038/s41467-022-35768-3
    as

    Download full text from publisher

    File URL: https://www.nature.com/articles/s41467-022-35768-3
    File Function: Abstract
    Download Restriction: no
    File URL: https://libkey.io/10.1038/s41467-022-35768-3?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. Chambaz Antoine & Hubbard Alan & van der Laan Mark J., 2016. "Special Issue on Data-Adaptive Statistical Inference," The International Journal of Biostatistics, De Gruyter, vol. 12(1), pages 1-1, May.
    2. Katherine McMahan & Jingyou Yu & Noe B. Mercado & Carolin Loos & Lisa H. Tostanoski & Abishek Chandrashekar & Jinyan Liu & Lauren Peter & Caroline Atyeo & Alex Zhu & Esther A. Bondzie & Gabriel Dagott, 2021. "Correlates of protection against SARS-CoV-2 in rhesus macaques," Nature, Nature, vol. 590(7847), pages 630-634, February.
    3. Hubbard Alan E. & Kherad-Pajouh Sara & van der Laan Mark J., 2016. "Statistical Inference for Data Adaptive Target Parameters," The International Journal of Biostatistics, De Gruyter, vol. 12(1), pages 3-19, May.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Craig A. Magaret & Li Li & Allan C. deCamp & Morgane Rolland & Michal Juraska & Brian D. Williamson & James Ludwig & Cindy Molitor & David Benkeser & Alex Luedtke & Brian Simpkins & Fei Heng & Yanqing, 2024. "Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features," Nature Communications, Nature, vol. 15(1), pages 1-22, December.
    2. Grace Kenny & Sophie O’Reilly & Neil Wrigley Kelly & Riya Negi & Colette Gaillard & Dana Alalwan & Gurvin Saini & Tamara Alrawahneh & Nathan Francois & Matthew Angeliadis & Alejandro Abner Garcia Leon, 2023. "Distinct receptor binding domain IgG thresholds predict protective host immunity across SARS-CoV-2 variants and time," Nature Communications, Nature, vol. 14(1), pages 1-11, December.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Victor Chernozhukov & Denis Chetverikov & Mert Demirer & Esther Duflo & Christian Hansen & Whitney Newey & James Robins, 2018. "Double/debiased machine learning for treatment and structural parameters," Econometrics Journal, Royal Economic Society, vol. 21(1), pages 1-68, February.
    2. Stijn Vansteelandt & Oliver Dukes, 2022. "Authors' reply to the Discussion of ‘Assumption‐lean inference for generalised linear model parameters’ by Vansteelandt and Dukes," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 84(3), pages 729-739, July.
    3. Li Wang & Markus H. Kainulainen & Nannan Jiang & Han Di & Gaston Bonenfant & Lisa Mills & Michael Currier & Punya Shrivastava-Ranjan & Brenda M. Calderon & Mili Sheth & Brian R. Mann & Jaber Hossain &, 2022. "Differential neutralization and inhibition of SARS-CoV-2 variants by antibodies elicited by COVID-19 mRNA vaccines," Nature Communications, Nature, vol. 13(1), pages 1-10, December.
    4. Dapeng Li & David R. Martinez & Alexandra Schäfer & Haiyan Chen & Maggie Barr & Laura L. Sutherland & Esther Lee & Robert Parks & Dieter Mielke & Whitney Edwards & Amanda Newman & Kevin W. Bock & Mahn, 2022. "Breadth of SARS-CoV-2 neutralization and protection induced by a nanoparticle vaccine," Nature Communications, Nature, vol. 13(1), pages 1-15, December.
    5. Eva Stadler & Martin T. Burgess & Timothy E. Schlub & Shanchita R. Khan & Khai Li Chai & Zoe K. McQuilten & Erica M. Wood & Mark N. Polizzotto & Stephen J. Kent & Deborah Cromer & Miles P. Davenport &, 2023. "Monoclonal antibody levels and protection from COVID-19," Nature Communications, Nature, vol. 14(1), pages 1-9, December.
    6. Ramon Roozendaal & Laura Solforosi & Daniel J. Stieh & Jan Serroyen & Roel Straetemans & Anna Dari & Muriel Boulton & Frank Wegmann & Sietske K. Rosendahl Huber & Joan E. M. van der Lubbe & Jenny Hend, 2021. "SARS-CoV-2 binding and neutralizing antibody levels after Ad26.COV2.S vaccination predict durable protection in rhesus macaques," Nature Communications, Nature, vol. 12(1), pages 1-10, December.
    7. Guiomar Casado-Fernández & Magdalena Corona & Montserrat Torres & Adolfo J. Saez & Fernando Ramos-Martín & Mario Manzanares & Lorena Vigón & Elena Mateos & Francisco Pozo & Inmaculada Casas & Valentín, 2023. "Sustained Cytotoxic Response of Peripheral Blood Mononuclear Cells from Unvaccinated Individuals Admitted to the ICU Due to Critical COVID-19 Is Essential to Avoid a Fatal Outcome," IJERPH, MDPI, vol. 20(3), pages 1-19, January.
    8. Payton A.-B. Weidenbacher & Mrinmoy Sanyal & Natalia Friedland & Shaogeng Tang & Prabhu S. Arunachalam & Mengyun Hu & Ozan S. Kumru & Mary Kate Morris & Jane Fontenot & Lisa Shirreff & Jonathan Do & Y, 2023. "A ferritin-based COVID-19 nanoparticle vaccine that elicits robust, durable, broad-spectrum neutralizing antisera in non-human primates," Nature Communications, Nature, vol. 14(1), pages 1-13, December.
    9. Vincent Pavot & Catherine Berry & Michael Kishko & Natalie G. Anosova & Lu Li & Tim Tibbitts & Dean Huang & Alice Raillard & Sylviane Gautheron & Cindy Gutzeit & Marguerite Koutsoukos & Roman M. Chicz, 2023. "Beta variant COVID-19 protein booster vaccine elicits durable cross-neutralization against SARS-CoV-2 variants in non-human primates," Nature Communications, Nature, vol. 14(1), pages 1-8, December.
    10. Victor Chernozhukov & Denis Chetverikov & Mert Demirer & Esther Duflo & Christian Hansen & Whitney Newey & James Robins, 2016. "Double/Debiased Machine Learning for Treatment and Causal Parameters," Papers 1608.00060, arXiv.org, revised Dec 2017.
    11. Laurent Renia & Yun Shan Goh & Angeline Rouers & Nina Bert & Wan Ni Chia & Jean-Marc Chavatte & Siew‐Wai Fong & Zi Wei Chang & Nicole Ziyi Zhuo & Matthew Zirui Tay & Yi-Hao Chan & Chee Wah Tan & Nicho, 2022. "Lower vaccine-acquired immunity in the elderly population following two-dose BNT162b2 vaccination is alleviated by a third vaccine dose," Nature Communications, Nature, vol. 13(1), pages 1-16, December.
    12. Iris N. Pardieck & Tetje C. van der Sluis & Esmé T. I. van der Gracht & Dominique M. B. Veerkamp & Felix M. Behr & Suzanne van Duikeren & Guillaume Beyrend & Jasper Rip & Reza Nadafi & Elham Beyranvan, 2022. "A third vaccination with a single T cell epitope confers protection in a murine model of SARS-CoV-2 infection," Nature Communications, Nature, vol. 13(1), pages 1-11, December.
    13. Rúbens Prince dos Santos Alves & Julia Timis & Robyn Miller & Kristen Valentine & Paolla Beatriz Almeida Pinto & Andrew Gonzalez & Jose Angel Regla-Nava & Erin Maule & Michael N. Nguyen & Norazizah Sh, 2024. "Human coronavirus OC43-elicited CD4+ T cells protect against SARS-CoV-2 in HLA transgenic mice," Nature Communications, Nature, vol. 15(1), pages 1-20, December.
    14. Elham Khatamzas & Markus H. Antwerpen & Alexandra Rehn & Alexander Graf & Johannes Christian Hellmuth & Alexandra Hollaus & Anne-Wiebe Mohr & Erik Gaitzsch & Tobias Weiglein & Enrico Georgi & Clemens , 2022. "Accumulation of mutations in antibody and CD8 T cell epitopes in a B cell depleted lymphoma patient with chronic SARS-CoV-2 infection," Nature Communications, Nature, vol. 13(1), pages 1-12, December.
    15. Christine D. Palmer & Ciaran D. Scallan & Lauren D. Kraemer Tardif & Melissa A. Kachura & Amy R. Rappaport & Daniel O. Koralek & Alison Uriel & Leonid Gitlin & Joshua Klein & Matthew J. Davis & Harshn, 2023. "GRT-R910: a self-amplifying mRNA SARS-CoV-2 vaccine boosts immunity for ≥6 months in previously-vaccinated older adults," Nature Communications, Nature, vol. 14(1), pages 1-17, December.
    16. Philipe Gobeil & Stéphane Pillet & Iohann Boulay & Nathalie Charland & Aurélien Lorin & Matthew P. Cheng & Donald C. Vinh & Philippe Boutet & Robbert Most & François Roman & Maria Angeles Ceregido & N, 2022. "Durability and cross-reactivity of immune responses induced by a plant-based virus-like particle vaccine for COVID-19," Nature Communications, Nature, vol. 13(1), pages 1-10, December.
    17. Aloysious Ssemaganda & Huong Mai Nguyen & Faisal Nuhu & Naima Jahan & Catherine M. Card & Sandra Kiazyk & Giulia Severini & Yoav Keynan & Ruey-Chyi Su & Hezhao Ji & Bernard Abrenica & Paul J. McLaren , 2022. "Expansion of cytotoxic tissue-resident CD8+ T cells and CCR6+CD161+ CD4+ T cells in the nasal mucosa following mRNA COVID-19 vaccination," Nature Communications, Nature, vol. 13(1), pages 1-9, December.
    18. Tomer Hertz & Shlomia Levy & Daniel Ostrovsky & Hanna Oppenheimer & Shosh Zismanov & Alona Kuzmina & Lilach M. Friedman & Sanja Trifkovic & David Brice & Lin Chun-Yang & Liel Cohen-Lavi & Yonat Shemer, 2023. "Correlates of protection for booster doses of the SARS-CoV-2 vaccine BNT162b2," Nature Communications, Nature, vol. 14(1), pages 1-16, December.
    19. Adriana Tomic & Donal T. Skelly & Ane Ogbe & Daniel O’Connor & Matthew Pace & Emily Adland & Frances Alexander & Mohammad Ali & Kirk Allott & M. Azim Ansari & Sandra Belij-Rammerstorfer & Sagida Bibi , 2022. "Divergent trajectories of antiviral memory after SARS-CoV-2 infection," Nature Communications, Nature, vol. 13(1), pages 1-20, December.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-022-35768-3. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.nature.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.