Developing a vaccine to prevent RSV
Research type
Research Study
Full title
A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age and RSV-seropositive Toddlers 12 to 24 Months of Age
IRAS ID
228889
Contact name
Matthew Snape
Contact email
Sponsor organisation
Janssen Vaccines and Prevention B.V.
Eudract number
2017-001345-27
Duration of Study in the UK
2 years, 6 months, days
Research summary
Respiratory syncytial virus (RSV) is considered to be the most important cause of serious acute respiratory illness in infants and children less than 5 years of age. Globally, RSV is responsible for an estimated 3.4 million hospitalizations annually. Despite the high disease burden, no licensed vaccine is available for RSV. The overall aim of this study is to develop a new vaccine, Ad26.RSV.preF for use in both infants and the elderly. This study aims to assess safety and tolerability of: i) Intramuscular regimen of two doses Ad26.RSV.preF in adults aged 18 to 50 years; ii) Intramuscular regimen of two doses of Ad26.RSV.preF in toddlers with previous exposure to RSV (seropositive) aged 12 to 24 months. Enrollment will be staggered to allow safety assessments to be made 7 days after the first dose in adult cohort before enrolling and dosing toddlers.
Participants will be randomised to receive an injection of vaccination or placebo. Participants will be observed for 30 minutes after the injection,and all participants or their parents will be asked to complete a diary for one week to assess for any symptoms or adverse events from having the injection. Participants will have blood samples for assessment of antibody levels and immune cell response before the injection, and 28 days and 6 months after the final dose. Toddler participants will also be monitored for signs of an RSV infection in the month following vaccination and through out the RSV season and, if present, will receive a nose swab to test for the infection.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0462
Date of REC Opinion
28 Sep 2017
REC opinion
Favourable Opinion