Evidence map›Paper›PMID 37640860›Full record

Trial reportNature medicine2023

Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.

Angela R Branche, Nadine G Rouphael, David J Diemert, Ann R Falsey, Cecilia Losada, Lindsey R Baden, Sharon E Frey, Jennifer A Whitaker, Susan J Little, Evan J Anderson and 59 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing 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

35 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. 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
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Acute SARS-CoV-2 infection.Nature reviews. Disease primers · 2025
    Review
  13. Historical Advances in Clinical Trial Design and Expanding Representation as the New Frontier for Innovation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

69 authors.

Angela R Branche *Department of Medicine, Division of Infectious Diseases, University of Rochester, Rochester, NY, USA. angela_branche@urmc.rochester.edu.ORCID http://orcid.org/0000-0002-7742-5352
Nadine G Rouphael *Hope Clinic, Emory University, Decatur, GA, USA.
David J DiemertGeorge Washington Vaccine Research Unit, George Washington University, Washington D.C., WA, USA.ORCID http://orcid.org/0000-0002-2789-0512
Ann R FalseyDepartment of Medicine, Division of Infectious Diseases, University of Rochester, Rochester, NY, USA.
Cecilia LosadaHope Clinic, Emory University, Decatur, GA, USA.
Lindsey R BadenBrigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Sharon E FreyCenter for Vaccine Development, Saint Louis University, St. Louis, MO, USA.
Jennifer A WhitakerDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, TX, USA.
Susan J LittleDivision of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.ORCID http://orcid.org/0000-0002-7645-9737
Evan J AndersonCenter for Childhood Infections and Vaccines (CCIV) of Children's Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-1576-4420
Emmanuel B WalterDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.
Richard M NovakProject WISH, University of Illinois at Chicago, Chicago, IL, USA.
Richard RuppUniversity of Texas Medical Branch, Galveston, TX, USA.
Lisa A JacksonKaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Tara M BabuDepartments of Medicine, Epidemiology and Laboratory Medicine and Pathology, University of Washington, Vaccines and Infectious Diseases Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Angelica C KottkampNYU VTEU Manhattan Research Clinic, NYU Grossman School of Medicine, New York, NY, USA.ORCID http://orcid.org/0000-0003-4103-1666
Anne F LuetkemeyerZuckerberg San Francisco General, University of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0003-0911-1578
Lilly C ImmergluckDepartment of Microbiology, Biochemistry and Immunology, and Clinical Research Center, Morehouse School of Medicine, Atlanta, GA, USA.
Rachel M PrestiWashington University School of Medicine, St. Louis, MO, USA.ORCID http://orcid.org/0000-0002-5469-0727
Martín BäckerNYU VTEU Long Island Research Clinic, NYU Long Island School of Medicine, Mineola, NY, USA.
Patricia L WinokurCollege of Medicine, University of Iowa, Iowa City, IA, USA.
Siham M MahgoubHoward University College of Medicine, Howard University Hospital, Washington D.C., WA, USA.
Paul A GoepfertDepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Dahlene N FuscoTulane University School of Medicine, New Orleans, LA, USA.ORCID http://orcid.org/0000-0002-5629-0110
Elissa MalkinGeorge Washington Vaccine Research Unit, George Washington University, Washington D.C., WA, USA.ORCID http://orcid.org/0000-0003-0943-5433
Jeffrey M BethonyGeorge Washington Vaccine Research Unit, George Washington University, Washington D.C., WA, USA.
Edward E WalshDepartment of Medicine, Division of Infectious Diseases, University of Rochester, Rochester, NY, USA.
Daniel S GraciaaHope Clinic, Emory University, Decatur, GA, USA.ORCID http://orcid.org/0000-0002-9484-8488
Hady SamahaHope Clinic, Emory University, Decatur, GA, USA.ORCID http://orcid.org/0000-0002-9124-7820
Amy C ShermanBrigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-6075-3990
Stephen R WalshBrigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-0817-9370
Getahun AbateCenter for Vaccine Development, Saint Louis University, St. Louis, MO, USA.
Zacharoula OikonomopoulouCenter for Vaccine Development, Saint Louis University, St. Louis, MO, USA.
Hana M El SahlyDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, TX, USA.
Thomas C S MartinDivision of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.
Satoshi KamidaniCenter for Childhood Infections and Vaccines (CCIV) of Children's Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta, GA, USA.ORCID http://orcid.org/0000-0001-6829-0700
Michael J SmithDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.
Benjamin G LadnerProject WISH, University of Illinois at Chicago, Chicago, IL, USA.
Laura PorterfieldUniversity of Texas Medical Branch, Galveston, TX, USA.ORCID http://orcid.org/0000-0001-9144-144X
Maya DunstanKaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Anna WaldDepartments of Medicine, Epidemiology and Laboratory Medicine and Pathology, University of Washington, Vaccines and Infectious Diseases Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Tamia DavisNYU VTEU Manhattan Research Clinic, NYU Grossman School of Medicine, New York, NY, USA.
Robert L AtmarDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, TX, USA.ORCID http://orcid.org/0000-0001-9989-6772
Mark J MulliganNYU VTEU Manhattan Research Clinic, NYU Grossman School of Medicine, New York, NY, USA.
Kirsten E LykeCenter for Vaccine Development and Global Health, University of Maryland School of Medicine Baltimore, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-4966-0830
Christine M PosavadIDCRC Laboratory Operations Unit, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Megan A MeagherIDCRC Laboratory Operations Unit, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID http://orcid.org/0009-0009-6915-4861
David S StephensDepartment of Medicine and Woodruff Health Sciences Center, Emory University, Atlanta, GA, USA.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine Baltimore, Baltimore, MD, USA.ORCID http://orcid.org/0000-0001-9480-2714
Kuleni AbebeFHI 360, Durham, NC, USA.
Heather HillDepartment of Surgery, Duke University Medical Center, Durham, NC, USA.
Jim AlbertThe Emmes Company, LLC, Rockville, MD, USA.
Kalyani TeluThe Emmes Company, LLC, Rockville, MD, USA.
Jinjian MuThe Emmes Company, LLC, Rockville, MD, USA.ORCID http://orcid.org/0000-0002-3270-6775
Teri C LewisClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Lisa A GiebeigClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Amanda EatonDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.ORCID http://orcid.org/0000-0003-3064-2947
Antonia NetzlCenter for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0001-8034-2382
Samuel H WilksCenter for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge, UK.ORCID http://orcid.org/0000-0002-7760-8474
Sina TüreliCenter for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge, UK.
Mamodikoe MakheneDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Sonja CrandonDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
David C MontefioriDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.
Mat MakowskiThe Emmes Company, LLC, Rockville, MD, USA.
Derek J SmithCenter for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge, UK.
Seema U NayakDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Paul C Roberts *Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-4452-141X
John H Beigel *Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-4879-4941
COVAIL Study Group

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
Statistical Data Coordinating Center: Monkeypox Clinical Research Support75N93021C00012 · NIAID · THE EMMES COMPANY, LLC · PI EWELL, MARIAN · 2021 to 2025
$150.3M
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
Collaborative Influenza Vaccine Innovation Centers (CIVICs): Component A: Vaccine Center75N93019C00050 · NIAID · DUKE UNIVERSITY · PI MOODY, TONY · 2019 to 2025
$69.1M
NIAID Centers of Excellence for Influenza Research and Response: Universal Influenza Vaccine Research Activities75N93021C00014 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI GARCIA-SASTRE, ADOLFO · 2021 to 2025
$62.6M
Vaccine and Treatment Evaluation Units - DMID 21-0012UM1AI148576 · NIAID · EMORY UNIVERSITY · PI Nadine Georges Rouphael, Carlos del Rio · 2020 to 2026
$41.7M
Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) - DMID 21-0012UM1AI148574 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Angelica Cifuentes Kottkamp, Anoma Nellore · 2020 to 2026
$23.9M
University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric StudyUM1AI148450 · NIAID · UNIVERSITY OF ROCHESTER · PI Angela Ramona Branche, Ann R Falsey · 2020 to 2026
$20.6M
CLINICAL CENTRAL LABORATORY SERVICES TO SUPPORT COVID-19 VACCINE STUDIES75N93021D00021 · NIAID · PI BEECH, TIFFANI · 2021 to 2023
$1.6M
BLRD VA I01 BX000207CLC NIH HHS C0000008NCI NIH HHS 75N91019D00024NIAID NIH HHS 75N93019C00050NIAID NIH HHS 75N93021C00012NIAID NIH HHS 75N93021C00014NIAID NIH HHS 75N93021D00021NIAID NIH HHS UM1 AI148450NIAID NIH HHS UM1 AI148574NIAID NIH HHS UM1 AI148576NIAID NIH HHS UM1 AI148684
6 · The paper itself

Abstract

Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID

Indexed as

COVID-19COVID-19 VaccinesBroadly Neutralizing AntibodiesHumansSARS-CoV-2Broadly Neutralizing AntibodiesCOVID-19 Vaccines

Identifiers

PMID37640860
PMCPMC10504073

What OpenQuestion holds

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LicenceCC BY
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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.