Evidence map›Paper›PMID 37512961›Full record

ArticleMicroorganisms2023

A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection.

Mingzhu Zhu, Shane Cloney-Clark, Sheau-Line Feng, Anand Parekh, Drew Gorinson, David Silva, Paul Skonieczny, Adjele Wilson, Raj Kalkeri, Wayne Woo and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
4.1field-weighted citation impact, top 5% 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

6 citing papers in PubMed, 21 citations in OpenAlex.

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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

14 authors at 1 institution in 1 country.

Mingzhu ZhuClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.ORCID 0009-0005-1628-7442
Shane Cloney-ClarkClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Sheau-Line FengClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Anand ParekhClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Drew GorinsonClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
David SilvaClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Paul SkoniecznyClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Adjele WilsonClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Raj KalkeriClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Wayne WooBiostatistics, Novavax, Inc., Gaithersburg, MD 20878, USA.
Miranda R CaiBiostatistics, Novavax, Inc., Gaithersburg, MD 20878, USA.
Louis FriesClinical Development, Novavax, Inc., Gaithersburg, MD 20878, USA.
Greg GlennDiscovery, Novavax, Inc., Gaithersburg, MD 20878, USA.
Joyce S PlestedClinical Immunology, Novavax, Inc., Gaithersburg, MD 20878, USA.
Novavax (United States) · US

Funding

Novavax (United States) N/A
6 · The paper itself

Abstract

As the COVID-19 pandemic continues, variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to emerge. Immunogenicity evaluation of vaccines and identification of correlates of protection for vaccine effectiveness is critical to aid the development of vaccines against emerging variants. Anti-recombinant spike (rS) protein immunoglobulin G (IgG) quantitation in the systemic circulation (serum/plasma) is shown to correlate with vaccine efficacy. Thus, an enzyme-linked immunosorbent assay (ELISA)-based binding assay to detect SARS-CoV-2 (ancestral and variant strains) anti-rS IgG in human serum samples was developed and validated. This assay successfully met acceptance criteria for inter/intra-assay precision, specificity, selectivity, linearity, lower/upper limits of quantitation, matrix effects, and assay robustness. The analyte in serum was stable for up to 8 freeze/thaw cycles and 2 years in -80 °C storage. Similar results were observed for the Beta, Delta, and Omicron BA.1/BA.5/XBB.1.5 variant-adapted assays. Anti-rS IgG assay results correlated significantly with neutralization and receptor binding inhibition assays. In addition, usage of international reference standards allows data extrapolation to WHO international units (BAU/mL), facilitating comparison of results with other IgG assays. This anti-rS IgG assay is a robust, high-throughput method to evaluate binding IgG responses to S protein in serum, enabling rapid development of effective vaccines against emerging COVID-19 variants.

Indexed as

antibodiesBinding antibodiescorrelate of protectionCOVID-19ELISAIgGOmicron BA.1/BA.5/XBB.1.5 SARS-CoV-2 variantsvariants of concern

Identifiers

PMID37512961
PMCPMC10383018
OpenAlexW4384037040

What OpenQuestion 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 OpenQuestion graph.