Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans.


Journal

Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899

Informations de publication

Date de publication:
28 03 2019
Historique:
received: 12 09 2018
revised: 14 12 2018
accepted: 05 02 2019
pubmed: 10 3 2019
medline: 8 8 2020
entrez: 10 3 2019
Statut: ppublish

Résumé

Adjuvants like AS01 The trial involved 60 hepatitis B-naïve adults aged 18-45 years randomized 1:1 to receive either two doses of HBsAg-AS01 The vaccine with AS01 IL-6 and IFN-γ signals were associated with systemic reactogenicity following administration of AS01 www.clinicaltrials.gov NCT01777295.

Sections du résumé

BACKGROUND
Adjuvants like AS01
METHODS
The trial involved 60 hepatitis B-naïve adults aged 18-45 years randomized 1:1 to receive either two doses of HBsAg-AS01
FINDINGS
The vaccine with AS01
CONCLUSIONS
IL-6 and IFN-γ signals were associated with systemic reactogenicity following administration of AS01
TRIAL REGISTRATION
www.clinicaltrials.gov NCT01777295.

Identifiants

pubmed: 30850240
pii: S0264-410X(19)30209-9
doi: 10.1016/j.vaccine.2019.02.015
pii:
doi:

Substances chimiques

Biomarkers 0
Cytokines 0
Hepatitis B Antibodies 0
Hepatitis B Vaccines 0
Inflammation Mediators 0

Banques de données

ClinicalTrials.gov
['NCT01777295', 'NCT00805389']

Types de publication

Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2004-2015

Informations de copyright

Copyright © 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Wivine Burny (W)

GSK, Rixensart/Wavre, Belgium. Electronic address: Wivine.Burny@GSK.com.

Arnaud Marchant (A)

Institute for Medical Immunology, Université libre de Bruxelles, Charleroi, Belgium.

Caroline Hervé (C)

GSK, Rixensart/Wavre, Belgium.

Andrea Callegaro (A)

GSK, Rixensart/Wavre, Belgium.

Magalie Caubet (M)

GSK, Rixensart/Wavre, Belgium.

Laurence Fissette (L)

GSK, Rixensart/Wavre, Belgium.

Lien Gheyle (L)

SGS Life Science Services, Antwerp, Belgium.

Catherine Legrand (C)

Institute of Statistics, Biostatistics and Actuarial Sciences (ISBA), Université Catholique de Louvain, Louvain-la-Neuve, Belgium.

Cheikh Ndour (C)

Institute of Statistics, Biostatistics and Actuarial Sciences (ISBA), Université Catholique de Louvain, Louvain-la-Neuve, Belgium.

Fernanda Tavares Da Silva (F)

GSK, Rixensart/Wavre, Belgium.

Robbert van der Most (R)

GSK, Rixensart/Wavre, Belgium.

Fabienne Willems (F)

Institute for Medical Immunology, Université libre de Bruxelles, Charleroi, Belgium.

Arnaud M Didierlaurent (AM)

GSK, Rixensart/Wavre, Belgium.

Juan Yarzabal (J)

GSK, Rixensart/Wavre, Belgium.

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Classifications MeSH