Evidence map›Paper›PMID 26616263›Full record

ArticleInfluenza and other respiratory viruses2016

A novel approach for preparation of the antisera reagent for potency determination of inactivated H7N9 influenza vaccines.

Falko Schmeisser, Xianghong Jing, Manju Joshi, Anupama Vasudevan, Jackeline Soto, Xing Li, Anil Choudhary, Noel Baichoo, Josephine Resnick, Zhiping Ye and 2 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Influenza and other respiratory viruses, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 26% 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

7 citing papers in PubMed, 6 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

12 authors at 1 institution in 1 country.

Falko SchmeisserLaboratory of DNA Viruses, Division of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Xianghong JingLaboratory of Respiratory Viral Diseases, Division of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Manju JoshiDivision of Biological Standards and Quality Control, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Anupama VasudevanLaboratory of DNA Viruses, Division of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Jackeline SotoLaboratory of Respiratory Viral Diseases, Division of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Xing LiLaboratory of Respiratory Viral Diseases, Division of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Anil ChoudharyDivision of Biological Standards and Quality Control, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Noel BaichooDivision of Biological Standards and Quality Control, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Josephine ResnickDivision of Biological Standards and Quality Control, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Zhiping YeLaboratory of Respiratory Viral Diseases, Division of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
William McCormickDivision of Biological Standards and Quality Control, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Jerry P WeirLaboratory of DNA Viruses, Division of Viral Products, Center for Biologics Evaluations and Research, Food and Drug Administration, Silver Spring, MD, USA.
Center for Biologics Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe potency of inactivated influenza vaccines is determined using a single-radial immunodiffusion (SRID) assay and requires standardized reagents consisting of a Reference Antigen and an influenza strain-specific antiserum. Timely availability of reagents is a critical step in influenza vaccine production, and the need for backup approaches for reagent preparation is an important component of pandemic preparedness.

objectivesWhen novel H7N9 viruses emerged in China in 2013, candidate inactivated H7N9 influenza vaccines were developed for evaluation in clinical trials, and reagents were needed to measure vaccine potency.

methodsWe previously described an alternative approach for generating strain-specific potency antisera, utilizing modified vaccinia virus Ankara vectors to produce influenza hemagglutinin (HA)-containing virus-like particles (VLPs) for immunization. Vector-produced HA antigen is not dependent upon the success of the traditional bromelain-digestion and HA purification.

resultsAntiserum for H7N9 vaccines, produced after immunization of sheep with preparations of bromelain-HA (br-HA), was not optimal for the SRID assay, and the supply of antiserum was limited. However, antiserum obtained from sheep boosted with VLPs containing H7 HA greatly improved the ring quality in the SRID assay. Importantly, this antiserum worked well with both egg- and cell-derived antigen and was distributed to vaccine manufacturers.

conclusionsUtilizing a previously developed approach for preparing vaccine potency antiserum, we have addressed a major bottleneck encountered in preparation of H7N9 vaccine reagents. The combination of br-HA and mammalian VLPs for sequential immunization represents the first use of an alternative approach for producing an influenza vaccine potency antiserum.

Indexed as

Vaccine PotencyAnimalsAntibodies, ViralChinaHemagglutinin Glycoproteins, Influenza VirusHumansImmune SeraImmunodiffusionInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H5N1 SubtypeInfluenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza VaccinesPandemicsSheepVaccines, InactivatedAntibodies, Viralhemagglutinin, avian influenza A virusHemagglutinin Glycoproteins, Influenza VirusImmune SeraInfluenza VaccinesVaccines, InactivatedVaccines, Virus-Like ParticleInfluenza vaccine reagentsinfluenza vaccinessingle-radial immunodiffusion assayvaccine potency assay

Identifiers

PMID26616263
PMCPMC4746557
OpenAlexW2273884528

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.