A single immunogenicity assay for testing potency of combination DTaP vaccines: Simultaneous quantitation of anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies in Guinea-pig serum with a Luminex®-xMAP® bead-based serological assay.

Animals Antibodies, Bacterial / blood Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology Guinea Pigs Serologic Tests
Acellular pertussis Combination vaccines Magnetic beads Potency Single immunogenicity assay

Journal

Biologicals : journal of the International Association of Biological Standardization
ISSN: 1095-8320
Titre abrégé: Biologicals
Pays: England
ID NLM: 9004494

Informations de publication

Date de publication:
Sep 2019
Historique:
received: 06 06 2019
revised: 01 08 2019
accepted: 03 08 2019
pubmed: 28 8 2019
medline: 6 2 2020
entrez: 28 8 2019
Statut: ppublish

Résumé

The diphtheria toxoid (DT), tetanus toxoid (TT), and acellular pertussis (aP) single immunogenicity assay (DTaP SIA) is a Luminex®-xMAP®-bead-based multiplex immunoassay for estimating the potency of DTaP pediatric combination vaccines in guinea pigs. This manuscript describes the validation of this assay for the simultaneous quantitation of anti-diphtheria toxoid (anti-DT), anti-tetanus toxoid (anti-TT), anti-pertussis toxoid (anti-PTxd), and anti-filamentous hemagglutinin (anti-FHA) antibodies in guinea pig serum following injection of a DTaP vaccine formulation. The results were expressed in arbitrary units/mL (AU/mL) using reference serum for comparison. Specificity was demonstrated by ≥ 75% homologous and ≤25% heterologous inhibition for all the antigens. The results were linear for anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies. Accuracy was demonstrated with recovery of between 80% and 120% for all four antibodies. The relative standard deviation of repeatability was ≤20%. The results demonstrate that this SIA can be used for the linear, accurate, and precise simultaneous detection of all four antibodies, based on both the ICH Q2 and the EMA guidelines on bioanalytical method validation.

Identifiants

DOI: 10.1016/j.biologicals.2019.08.002 PMID: 31451353
pubmed: 31451353
pii: S1045-1056(19)30080-6
doi: 10.1016/j.biologicals.2019.08.002
pii:
doi:

Substances chimiques

Antibodies, Bacterial 0
Diphtheria-Tetanus-acellular Pertussis Vaccines 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

15-21

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Silvio Bandiera (S)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Silvio.Bandiera@sanofi.com.

Annabelle Lebas (A)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Annabelle.Lebas@sanofi.com.

Livia Canizares-Martinello (L)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Livia.Martinello@sanofi.com.

Fabien Guinchard (F)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Fabien.Guinchard@sanofi.com.

Corinne Lyonnais (C)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Corinne.Lyonnais@sanofi.com.

Sophie Perrin (S)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Sophie.Perrin@sanofi.com.

Marine Nicolas (M)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Marine.Nicolas@sanofi.com.

Sylvie Uhlrich (S)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Sylvie.Uhlrich@sanofi.com.

Martine Chabaud-Riou (M)

Sanofi Pasteur, Campus Mérieux, 1541 Avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Martine.Chabaud-Riou@sanofi.com.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › A single immunogenicity assay for testing...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps antibactériens › A single immunogenicity assay for testing...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins sous-unitaires › Vaccins acellulaires › Vaccins diphtérique tétanique coquelucheux acellulaires › A single immunogenicity assay for testing...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Rodentia › Cochons d'Inde › A single immunogenicity assay for testing...
questionsmedicales.fr › Techniques d'investigation › Techniques immunologiques › Tests immunologiques › Tests sérologiques › A single immunogenicity assay for testing...