A Phase 1/2a Study of Various RSV preF-Based Vaccine Formulations in Adults Aged 60 Years and Older
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations of various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older
IRAS ID
1004127
Contact name
Hanneke Schuitemaker
Contact email
Sponsor organisation
Janssen Vaccines & Prevention B.V.
Eudract number
2022-001015-14
Clinicaltrials.gov Identifier
Research summary
RSV stands for respiratory syncytial virus and is responsible of infecting the respiratory tracts. This virus can make sick subjects of all ages and is particularly virulent for babies, patients with compromised immune system and elderly subjects. RSV infection gives mild, cold like symptoms of the upper respiratory tracts for most people. People vulnerable can experience worsening of symptoms affecting also the lower respiratory tract that can result in severe infections and in some cases RSV can be a life threating condition . Despite this virus is very diffused and it has been staying with humans for more than 350 years there is no vaccine treatment to prevent infections. Janssen is testing a vaccine for RSV and in this study is proposing to administer the vaccine to people over 60 years old and will monitor how this vaccine will stimulate the immune response, if it is safe and how long will last the vaccine protection (if any). The vaccine will be tested as different formulations and some investigations will be conducted to identify the efficacy of a revaccination.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0199
Date of REC Opinion
28 Jul 2022
REC opinion
Further Information Favourable Opinion