Developing a vaccine to prevent RSV, a common cause of bronchiolitis
Research type
Research Study
Full title
A Randomized, controlled, observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
IRAS ID
257722
Contact name
Saul Faust
Contact email
Sponsor organisation
Janssen Vaccines and Prevention B.V.
Eudract number
2017-003859-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 3 days
Research summary
Respiratory syncytial virus (RSV) is considered to be the most important cause of serious acute respiratory illness in infants and children l 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 an intramuscular regimen of three doses of Ad26.RSV.preF in toddlers without previous exposure to RSV aged 12 to 24 months.Participants will be randomised to receive either study vaccine or a sterile water injection (placebo). Three injections of study vaccine will be given one month apart, the control group will receive placebo for their first two visits & a vaccination of Nimenrix at the third. Participants will be observed for at least 30 min after each injection and parents/guardians will be asked to complete a diary detailing any signs or symptoms for at least 1 week after injection. At 2 days after each injection they will receive a phone call and will attend an appointment at 7 days, vital signs will be checked. There are 4-5 blood tests taken during the study. The first is at screening with blood taken to check the participant's RSV status (ie if they are RSV seropositive or seronegative). Other blood tests will assess antibody levels & immune cell response before the injection, 7 days after the first injection, 1 month after the last dose & at the end of the first RSV season after injection. A nose swab will be taken prior to the first vaccination & 1 month after the last. Participants will be monitored for signs of respiratory infection during RSV season & a nose swab will be taken if present.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0031
Date of REC Opinion
20 Feb 2019
REC opinion
Favourable Opinion