Evidence map›Paper›PMID 40930044›Full record

Trial reportVaccine2025

Effect of Omicron BA.1-based compared to prototype booster mRNA vaccination on incidence of COVID-19 in the COVAIL trial.

David J Diemert, Daniel S Graciaa, Bo Zhang, Nadine G Rouphael, Angela R Branche, Thomas C S Martin, Lisa A Jackson, Rachel M Presti, Satoshi Kamidani, Siham M Mahgoub and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05289037 (Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants), which is not on this 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.

NCT05289037 phase2completednot on this map

Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2022 to 2023Enrolled1,270ConditionsCOVID-19ArmsAS03, BNT162b2, BNT162b2 (B.1.1.529), BNT162b2 (B.1.351), BNT162b2 bivalent (wildtype and Omicron BA.1)
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

19 authors.

David J DiemertDepartment of Medicine, School of Medicine and Health Sciences, The George Washington University, Washington, DC, USA. Electronic address: ddiemert@gwu.edu.
Daniel S GraciaaHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Emory University School of Medicine, Decatur, GA, USA.
Bo ZhangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Nadine G RouphaelHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Emory University School of Medicine, Decatur, GA, USA.
Angela R BrancheVaccine and Treatment Evaluation Unit, University of Rochester, Rochester, New York, USA.
Thomas C S MartinUniversity of California, San Diego, La Jolla, California, USA.
Lisa A JacksonKaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
Rachel M PrestiDepartment of Medicine, Washington University School of Medicine, St Louis, MO, USA.
Satoshi KamidaniCenter for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, GA, USA; Department of Pediatrics, Emory University, Atlanta, GA, USA.
Siham M MahgoubHoward University College of Medicine, Howard University Hospital, Washington, DC, USA.
Tara M BabuDivision of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
Craig A MagaretVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Viviana SimonDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, NY, New York, USA; Center for Vaccine Research and Pandemic Preparedness (C-VaRPP), Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Pathology, Molecular and Cell Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA; The Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Harm van BakelDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, NY, New York, USA; Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Icahn Genomics Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Paul C RobertsDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
John H BeigelCenter for Vaccine Research and Pandemic Preparedness (C-VaRPP), Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA; Department of Biostatistics, School of Public Health, University of Washington, Seattle, Washington, USA.
Dean FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
NIH HHS 75N91019D00024
6 · The paper itself

Abstract

backgroundCovid-19 vaccines are updated to match circulating strains based on reasoning that better strain-matched immunogenicity should provide better protection. Randomized evidence with disease endpoints to support strain matching is lacking. We evaluated COVID-19 incidence among adults randomized to a second booster of Prototype or Omicron-based vaccines.

methodsCOVAIL was a four-stage Phase 2 clinical trial; results from Stages 1 (mRNA-1273 [Moderna]) and 2 (BNT162b2 [Pfizer/BioNTech]) are described here. Adults who had received a primary series and one booster of an authorized COVID-19 vaccine were eligible. Participants received one dose of either Prototype vaccine or a monovalent or bivalent Omicron BA.1 vaccine. SARS-CoV-2 neutralization titers (ID

results706 participants with pre- and day 15 post-vaccination ID

conclusionsOmicron-based vaccines as second boosters were more protective against COVID-19 relative to Prototype among those receiving BNT162b2 but not mRNA-1273. Differences between stages such as force of infection, antigen matching, and vaccine differences may explain this finding. CLINICALTRIALS: govRegistry Number: NCT05289037.

Indexed as

COVID-19COVID-19 VaccinesImmunization, SecondarySARS-CoV-22019-nCoV Vaccine mRNA-1273AdultAgedAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineFemaleHumansImmunogenicity, VaccineIncidenceMaleMiddle Aged2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesCOVID-19mRNA vaccineSARS-CoV-2Vaccine efficacyVariant

Identifiers

PMID40930044
PMCPMC13316942

What OpenQuestion holds

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Registered trials

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.