Adjuvant effect of TLR7 agonist adsorbed on aluminum hydroxide (AS37): A phase I randomized, dose escalation study of an AS37-adjuvanted meningococcal C conjugated vaccine.
Adjuvants, Immunologic
/ administration & dosage
Adult
Aluminum Hydroxide
/ immunology
Antibodies, Bacterial
/ immunology
Bacterial Vaccines
/ immunology
Female
Humans
Immunogenicity, Vaccine
/ immunology
Male
Meningococcal Vaccines
/ immunology
Middle Aged
Neisseria meningitidis
/ immunology
Toll-Like Receptor 7
/ immunology
Vaccination
/ methods
Young Adult
Journal
Clinical immunology (Orlando, Fla.)
ISSN: 1521-7035
Titre abrégé: Clin Immunol
Pays: United States
ID NLM: 100883537
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
07
02
2019
revised:
02
08
2019
accepted:
17
10
2019
pubmed:
2
11
2019
medline:
21
5
2020
entrez:
1
11
2019
Statut:
ppublish
Résumé
An adjuvant system (AS37) has been developed containing a synthetic toll-like receptor agonist (TLR7a). We conducted a phase I randomized, observer-blind, dose-escalation study to assess the safety and immunogenicity of an investigational AS37-adjuvanted meningococcus C (MenC) conjugate vaccine in healthy adults (NCT02639351). A control group received a licensed MenC conjugate alum-adjuvanted vaccine. Eighty participants were randomized to receive one dose of control or investigational vaccine containing AS37 (TLR7a dose 12.5, 25, 50, 100 μg). All vaccines were well tolerated, apart from in the TLR7a 100 μg dose group, which had three reports (18.8%) of severe systemic adverse events. Four weeks after vaccination, human complement serum bactericidal assay seroresponse rates against MenC were 56-81% in all groups, and ELISA seroresponses were ≥81% for all AS37-adjuvanted vaccine groups (100% in 50 and 100 μg dose groups) and 88% in the control group. Antibody responses were maintained at six months after vaccination.
Identifiants
pubmed: 31669193
pii: S1521-6616(19)30073-7
doi: 10.1016/j.clim.2019.108275
pii:
doi:
Substances chimiques
Adjuvants, Immunologic
0
Antibodies, Bacterial
0
Bacterial Vaccines
0
Meningococcal Vaccines
0
TLR7 protein, human
0
Toll-Like Receptor 7
0
serogroup C meningococcal conjugate vaccine
0
Aluminum Hydroxide
5QB0T2IUN0
Banques de données
ClinicalTrials.gov
['NCT02639351']
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
108275Informations de copyright
Copyright © 2019 GlaxoSmithKline Biologicals S.A. Published by Elsevier Inc. All rights reserved.