Evidence map›Paper›PMID 39540375›Full record

ArticleBioanalysis2024

Harmonization of Vaccine Ligand Binding Assays Validation.

Francis Dessy, Ivo Sonderegger, Leslie Wagner, Alessandra Buoninfante, Meenu Wadhwa, Joseph Agnes, Anastasia Aksyuk, Angelique Baclin, Marie Bonhomme, Shane Cloney-Clark and 33 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioanalysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

43 authors.

Francis DessyGlaxoSmithKline, Rixensart, Belgium.
Ivo SondereggerTakeda, Opfikon, Switzerland.
Leslie WagnerUS FDA, Silver Spring, MD, USA.
Alessandra BuoninfanteEU EMA, Amsterdam, Netherlands.
Meenu WadhwaUK MHRA, London, UK.
Joseph AgnesInovio Pharmaceuticals, San Diego, CA, USA.
Anastasia AksyukAstraZeneca, Gaithersburg, MD, USA.
Angelique BaclinGlaxoSmithKline, Rixensart, Belgium.
Marie BonhommePPD, Richmond, VA, USA.
Shane Cloney-ClarkNovavax, Gaithersburg, MD, USA.
Bart CorsaroOcugen, Malvern, PA, USA (currently at Corsaro Bioanalytical Consulting).
João Tavares NetoBrazil ANVISA, Brasilia, Brazil.
Louis FriesNovavax, Gaithersburg, MD, USA.
Luc GagnonIQVIA Laboratories Vaccines, Laval, QC, Canada.
Fabio GarofoloBRI Frontage, Vancouver, BC, Canada.
Peter GiardinaPfizer, Pearl River, NY, USA.
Tina GreenPPD, Richmond, VA, USA.
Nuria GuimeraJanssen, Leiden, South Holland, Netherlands.
Shannon HarrisHilleVax, Cambridge, MA, USA.
Roy HelmyMerck, West Point, PA, USA.
James HuleattBill & Melinda Gates Medical Research Institute, Cambridge, MA, USA.
Akiko Ishii-WatabeJapan MHLW, Tokyo, Japan.
Ralf JaegerIQVIA Laboratories Vaccines, Marburg, Germany.
Dewal JaniTakeda, San Diego, CA, USA.
Sarah JanssenJanssen, Leiden, South Holland, Netherlands.
Lisa KiersteadPPD, Richmond, VA, USA.
Karen MakarBill & Melinda Gates Foundation, Seattle, WA, USA.
Jean-Claude MarshallModerna, Mystic, CT, USA.
Christian MayerAustria AGES / EU EMA, Vienna, Austria.
Dulcyane Neiva MendesBrazil ANVISA, Brasilia, Brazil.
Rocio MurphySanofi, Swiftwater, PA, USA.
Sankeetha NadarajahWRIB, Toronto, ON, Canada.
Katrina NolanMerck, West Point, PA, USA.
Joyce PlestedNovavax, Gaithersburg, MD, USA.
Ingrid ScullyPfizer, Pearl River, NY, USA.
Therese SolstadNorway NoMA / EU EMA, Oslo, Norway (currently at GE Healthcare).
Jeroen StoopJanssen, Leiden, South Holland, Netherlands.
Charles TanPfizer, Collegeville, PA, USA.
Thorsten VerchMerck, West Point, PA, USA.
Deidre WilkinsAstraZeneca, Gaithersburg, MD, USA.
Arron XuInovio Pharmaceuticals, San Diego, CA, USA (currently at Kiniksa).
Lingyi ZhengModerna, Mystic, CT, USA.
Mingzhu ZhuNovavax, Gaithersburg, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The urgency and importance of organizing a global effort to harmonize clinical assay validation specific to the vaccine industry was identified during the drafting of the 2020 White Paper in Bioanalysis due to the lack of clarity and regulatory guidance/guidelines in vaccine immunoassay validation. Indeed, the Workshop on Recent Issues in Bioanalysis (WRIB) issues the White Paper in Bioanalysis yearly, which is one of the high-profile articles of the

Indexed as

VaccinesBiological AssayHumansImmunoassayLigandsValidation Studies as TopicLigandsVaccinesbioanalysisbiomarkersimmunogenicityLBAvaccinevalidationWRIB

Identifiers

PMID39540375
PMCPMC11581174

What OpenQuestion holds

Textmetadata
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.