Evidence map›Paper›PMID 40872881›Full record

ArticleVaccines2025

Epitope Profiling of SARS-CoV-2 Spike Antigen Provides a Novel Strategy for Developing ELISAs Specific for Different Spike Protein Variants in Bivalent Vaccine Formulations.

Luciano Ettorre, Trevor Williams, Camille Houy, Shaolong Zhu, Michael Kishko, Ali Azizi, Andrew D James, Beata Gajewska, Jason Szeto

Abstract read
In one paragraph

Article in Vaccines, 2025. 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. Review
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

9 authors.

Luciano EttorreAnalytical Sciences Immunology, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.
Trevor WilliamsAnalytical Sciences Immunology, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.
Camille HouyAnalytical Sciences Immunology, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.ORCID 0000-0001-6475-3202
Shaolong ZhuAnalytical Sciences Biochemistry, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.
Michael KishkoGlobal Antigen Design (Virology), Sanofi, 200 West Street, Waltham, MA 02451, USA.ORCID 0000-0001-5678-3583
Ali AziziAnalytical Sciences Immunology, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.ORCID 0009-0007-8394-4769
Andrew D JamesExternal Research and Development, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.ORCID 0000-0002-9069-6819
Beata GajewskaAnalytical Sciences North America, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.
Jason SzetoAnalytical Sciences Immunology, Sanofi, 1755 Steeles Avenue West, Toronto, ON M2R 3T4, Canada.

Funding

Biomedical Advanced Research and Development Authority W15QKN-16-9-1002
6 · The paper itself

Abstract

BACKGROUND/

objectivesAn initial COVID-19 candidate vaccine containing a purified ancestral SARS-CoV-2 spike antigen was characterized with an ELISA using recombinant monoclonal antibodies (mAbs) generated against this variant. Upon the emergence of a new Beta (B.1.351) spike variant early in the pandemic, the assessment of a bivalent vaccine containing ancestral and Beta spike antigens began. Due to accelerated project timelines, mAbs generated specifically against the Beta spike antigen were not available at the time to address assay development and vaccine testing requirements.

methodsUsing only the initial mAb panel raised against the ancestral spike antigen, an epitope-blocking ELISA strategy was developed to independently measure Beta spike antigen in bivalent vaccine formulations. To facilitate this, epitope profiling of spike antigens from both ancestral and Beta variants was performed with biolayer interferometry and hydrogen-deuterium exchange mass spectrometry using the original panel of mAbs.

resultsThe resulting blocking ELISA was precise and specific for the Beta spike antigen and detected the expected amount of this antigen in bivalent vaccine formulations. The specific amount of ancestral spike protein in the bivalent vaccine was also confirmed using the original ELISA developed at the onset of the pandemic.

conclusionsThis epitope-blocking strategy helped to overcome key reagent availability issues and could be applied to other projects involving related proteins.

Indexed as

antibodyantigenicitybiolayer interferometryCOVID-19ELISAepitopeHDX-MSin vitropotencySARs-CoV-2

Identifiers

PMID40872881
PMCPMC12390492

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.