A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older.
Humans
Male
Aged
Female
Middle Aged
Double-Blind Method
Antibodies, Viral
/ blood
Respiratory Syncytial Virus Infections
/ prevention & control
Respiratory Syncytial Virus Vaccines
/ immunology
Japan
Respiratory Syncytial Virus, Human
/ immunology
Vaccination
Immunogenicity, Vaccine
Aged, 80 and over
Adenoviridae
/ immunology
East Asian People
adenovirus serotype 26
respiratory syncytial
respiratory syncytial virus vaccine
virus adult vaccination
virus fusion proteins
Journal
Influenza and other respiratory viruses
ISSN: 1750-2659
Titre abrégé: Influenza Other Respir Viruses
Pays: England
ID NLM: 101304007
Informations de publication
Date de publication:
Jun 2024
Jun 2024
Historique:
revised:
13
05
2024
received:
06
06
2023
accepted:
19
05
2024
medline:
17
6
2024
pubmed:
17
6
2024
entrez:
16
6
2024
Statut:
ppublish
Résumé
Respiratory syncytial virus (RSV) is increasingly recognized as a significant cause of lower respiratory tract disease (LRTD) in older adults. The Ad26.RSV.preF/RSV preF protein vaccine demonstrated protective efficacy against RSV related LRTD in a Phase 2b study in the United States. Hence, Ad26.RSV.preF/RSV preF protein vaccine candidate was evaluated in the Japanese older adult population. This Phase 1 study evaluated safety, reactogenicity, and immunogenicity of Ad26.RSV.preF/RSV preF protein vaccine at dose level of 1 × 10 There were no deaths, SAEs, or AEs leading to discontinuation reported during the study. The Ad26.RSV.preF/RSV preF protein vaccine had acceptable safety and tolerability profile with no safety concern in Japanese older adults. The Ad26.RSV.preF/RSV preF protein vaccine induced RSV-specific humoral immunity, with increase in antibody titers on Days 15 and 29 compared with baseline which was well maintained until Day 183. A single dose of Ad26.RSV.preF/RSV preF protein vaccine had an acceptable safety and tolerability profile and induced RSV-specific humoral immunity in Japanese healthy adults. NCT number: NCT04354480; Clinical Registry number: CR108768.
Sections du résumé
BACKGROUND
BACKGROUND
Respiratory syncytial virus (RSV) is increasingly recognized as a significant cause of lower respiratory tract disease (LRTD) in older adults. The Ad26.RSV.preF/RSV preF protein vaccine demonstrated protective efficacy against RSV related LRTD in a Phase 2b study in the United States. Hence, Ad26.RSV.preF/RSV preF protein vaccine candidate was evaluated in the Japanese older adult population.
METHODS
METHODS
This Phase 1 study evaluated safety, reactogenicity, and immunogenicity of Ad26.RSV.preF/RSV preF protein vaccine at dose level of 1 × 10
RESULTS
RESULTS
There were no deaths, SAEs, or AEs leading to discontinuation reported during the study. The Ad26.RSV.preF/RSV preF protein vaccine had acceptable safety and tolerability profile with no safety concern in Japanese older adults. The Ad26.RSV.preF/RSV preF protein vaccine induced RSV-specific humoral immunity, with increase in antibody titers on Days 15 and 29 compared with baseline which was well maintained until Day 183.
CONCLUSIONS
CONCLUSIONS
A single dose of Ad26.RSV.preF/RSV preF protein vaccine had an acceptable safety and tolerability profile and induced RSV-specific humoral immunity in Japanese healthy adults.
TRIAL REGISTRATION
BACKGROUND
NCT number: NCT04354480; Clinical Registry number: CR108768.
Substances chimiques
Antibodies, Viral
0
Respiratory Syncytial Virus Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT04354480']
Types de publication
Journal Article
Clinical Trial, Phase I
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13336Subventions
Organisme : Janssen Pharmaceutical K.K
Informations de copyright
© 2024 The Author(s). Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.
Références
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