Evidence map›Paper›PMID 36838333›Full record

ArticleMicroorganisms2023

Severe Acute Respiratory Syndrome Coronavirus 2 Receptor (Human Angiotensin-Converting Enzyme 2) Binding Inhibition Assay: A Rapid, High-Throughput Assay Useful for Vaccine Immunogenicity Evaluation.

Joyce S Plested, Mingzhu Zhu, Shane Cloney-Clark, Edmond Massuda, Urvashi Patel, Andrew Klindworth, Michael J Massare, Rongman Cai, Louis Fries, Greg Glenn and 1 more

Open access · goldAbstract read
In one paragraph

Article in Microorganisms, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
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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

11 authors at 1 institution in 1 country.

Joyce S PlestedClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Mingzhu ZhuClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Shane Cloney-ClarkClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Edmond MassudaClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Urvashi PatelClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.ORCID 0000-0003-2995-1515
Andrew KlindworthClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Michael J MassareDiscovery, Novavax, Gaithersburg, MD 20878, USA.
Rongman CaiBiostatistics, Novavax, Gaithersburg, MD 20878, USA.
Louis FriesClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Greg GlennDiscovery, Novavax, Gaithersburg, MD 20878, USA.
Raj KalkeriClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Novavax (United States) · US

Funding

Novavax (United States) NA
6 · The paper itself

Abstract

Emerging variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) show immune evasion of vaccine-derived immunity, highlighting the need for better clinical immunogenicity biomarkers. To address this need, an enzyme-linked immunosorbent assay-based, human angiotensin-converting enzyme 2 (hACE2) binding inhibition assay was developed to measure antibodies against the ancestral strain of SARS-CoV-2 and was validated for precision, specificity, linearity, and other parameters. This assay measures the inhibition of SARS-CoV-2 spike (S) protein binding to the receptor, hACE2, by serum from vaccine clinical trials. Inter- and intra-assay precision, specificity, linearity, lower limit of quantitation, and assay robustness parameters successfully met the acceptance criteria. Heme and lipid matrix effects showed minimal interference on the assay. Samples were stable for testing in the assay even with 8 freeze/thaws and up to 24 months in -80 °C storage. The assay was also adapted for variants (Delta and Omicron BA.1/BA.5), with similar validation results. The hACE2 assay showed significant correlation with anti-recombinant S immunoglobulin G levels and neutralizing antibody titers. This assay provides a rapid, high-throughput option to evaluate vaccine immunogenicity. Along with other clinical biomarkers, it can provide valuable insights into immune evasion and correlates of protection and enable vaccine development against emerging COVID-19 variants.

Indexed as

assay validationcorrelate of protectionCOVID-19human angiotensin-converting enzyme 2 (hACE2)immune evasionimmunogenicityneutralizing antibody titersSARS-CoV-2

Identifiers

PMID36838333
PMCPMC9965183
OpenAlexW4318777571

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.