Evidence map›Paper›PMID 29152878›Full record

ArticleInfluenza and other respiratory viruses2018

Potency determination of inactivated H7 influenza vaccines using monoclonal antibody-based ELISA and biolayer interferometry assays.

Anupama Vasudevan, Amy Woerner, Falko Schmeisser, Swati Verma, Ollie Williams, Jerry P Weir

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PubMed Full text at PMC Publisher
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Article in Influenza and other respiratory viruses, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

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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

6 authors.

Anupama VasudevanDivision of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Amy WoernerDivision of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Falko SchmeisserDivision of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Swati VermaDivision of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Ollie WilliamsDivision of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Jerry P WeirDivision of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-0260-0996

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe single radial immunodiffusion (SRID) assay, the accepted method for determining potency of inactivated influenza vaccines, measures an immunogenic form of the influenza hemagglutinin. Nevertheless, alternative methods for measuring vaccine potency have been explored to address some of the weaknesses of the SRID assay, including limited sensitivity and the requirement for large amounts of standardized reagents. Monoclonal antibody (mAb)-based potency assays also have the ability to detect and measure relevant immunogenic forms of HA.

objectivesThe objective of this study was to continue evaluation of mAb-based alternative methods for measuring the potency of inactivated influenza vaccines, focusing on A(H7N9) pandemic influenza vaccines.

methodsSeveral murine mAbs that recognize different epitopes on the H7 hemagglutinin (HA) were identified and characterized. These mAbs were evaluated in both a mAb-capture ELISA and a mAb-based biolayer interferometry (BLI) assay.

resultsResults indicated that potency of inactivated A(H7N9) vaccines, including vaccine samples that were stressed by heat treatment, measured by either alternative method correlated well with potency determined by the traditional SRID potency assay.

conclusionsThe availability of multiple H7 mAbs, directed to different HA epitopes, provides needed redundancy in the potency analysis as A(H7N9) viruses continue to evolve antigenically and suggests the importance of having a broad, well-characterized panel of mAbs available for development of vaccines against influenza strains with pandemic potential. In addition, the results highlight the potential of mAb-based platform such as ELISA and BLI for development as alternative methods for determining the potency of inactivated influenza vaccines.

Indexed as

Vaccine PotencyAnimalsAntibodies, MonoclonalAntibodies, ViralEnzyme-Linked Immunosorbent AssayHemagglutinin Glycoproteins, Influenza VirusImmunologic FactorsInfluenza A Virus, H7N9 SubtypeInfluenza VaccinesInterferometrySensitivity and SpecificityTechnology, PharmaceuticalVaccines, InactivatedAntibodies, MonoclonalAntibodies, Viralhemagglutinin, avian influenza A virusHemagglutinin Glycoproteins, Influenza VirusImmunologic FactorsInfluenza VaccinesVaccines, InactivatedA(H7N9)influenzapotency assay

Identifiers

PMID29152878
PMCPMC5820428

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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.