Evidence map›Paper›PMID 39597746›Full record

ArticleMicroorganisms2024

A Modified Novel Validated High-Throughput Hemagglutinin Inhibition Assay Using Recombinant Virus-like Particles and Human Red Blood Cells for the Objective Evaluation of Recombinant Hemagglutinin Nanoparticle Seasonal Influenza Vaccine.

Timothy S Vincent, Mingzhu Zhu, Anand Parekh, Urvashi Patel, Shane Cloney-Clark, Andrew Klindworth, David Silva, Andrew Gorinson, Karlee Miranda, Mi Wang and 8 more

Abstract read
In one paragraph

Article in Microorganisms, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. 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

18 authors.

Timothy S VincentClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Mingzhu ZhuClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.ORCID 0009-0005-1628-7442
Anand ParekhClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Urvashi PatelClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.ORCID 0000-0003-2995-1515
Shane Cloney-ClarkClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Andrew KlindworthClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
David SilvaClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Andrew GorinsonClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Karlee MirandaClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Mi WangClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Zachary LongacreVaccine Development, Novavax, Gaithersburg, MD 20878, USA.
Bin ZhouPreclinical Development, Vaccine Immunology, Novavax, Gaithersburg, MD 20878, USA.
Iksung ChoBiostatistics, Novavax, Gaithersburg, MD 20878, USA.
Rongman CaiBiostatistics, Novavax, Gaithersburg, MD 20878, USA.
Raj KalkeriClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.
Louis FriesContractor, Novavax, Gaithersburg, MD 20878, USA.
Vivek ShindeClinical Development, Novavax, Gaithersburg, MD 20878, USA.
Joyce S PlestedClinical Immunology, Novavax, Gaithersburg, MD 20878, USA.

Funding

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

Abstract

Currently available seasonal influenza vaccines confer variable protection due to antigenic changes resulting from the accumulation of diverse mutations. The analysis of new seasonal influenza vaccines is challenging in part due to the limitations of the traditional hemagglutination inhibition (HAI) assay with A/H3N2 strains. An improved and objective novel HAI assay was developed with recombinant virus-like particles (VLPs) and an egg-derived virus as agglutinins, the oseltamivir treatment of VLPs, human red blood cells, and using an automated image reader-based analysis of hemagglutination. HAI validation was demonstrated using four VLPs and egg-derived strains, with 46-56 serum samples tested 12 times in duplicate per strain. The validated HAI assay was precise as indicated by the percent geometric coefficient of variation for intra-, inter-, and total assay precision, as well as accurate as evidenced by percent bias measurements. The assay exhibited linearity, specificity for homologous type/subtype strains, and sensitivity with a starting dilution of 1:10. Assay robustness and sample stability were demonstrated as a percentage difference compared to reference condition. Validated HAI results were equivalent for the single and duplicate sample testing and correlated well with a qualified live wild-type influenza microneutralization assay. These findings demonstrate the suitability of this high-throughput novel modified validated HAI assay for evaluating vaccine immunogenicity and efficacy.

Indexed as

CypherOne™ Hemagglutination Analyzer (InDevR, Boulder, CO, USA)egg-derived influenza viruseshemagglutination inhibitionhuman red blood cellsimmunogenicityinfluenza vaccineinfluenza virussingletonvalidationvirus-like particles

Identifiers

PMID39597746
PMCPMC11596312

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Registered trials

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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.