Study to evaluate the efficacy of Ad26.RSV.preF vaccine against RSV
Research type
Research Study
Full title
An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults
IRAS ID
234391
Contact name
Bryan J Murray
Contact email
Sponsor organisation
Janssen
Eudract number
2017-003194-33
Duration of Study in the UK
0 years, 10 months, 14 days
Research summary
This is a study in which healthy adults will be given an experimental vaccine (study drug) called Ad26.RSV.preF and later infected with a virus called the Respiratory Syncytial Virus (RSV); one of the viruses that cause common cold. The study drug will be given as an injection in the arm.
The purpose of the study is to see if the study drug will be an effective treatment for RSV infection and to evaluate its safety.
Up to 44 male and female healthy participants aged 18-50 years old will receive the study virus and the study dug or placebo (a dummy drug) in this study.
The study consists of 4 parts:- Screening Phase: this will take place between 8 weeks to 3 days before vaccination. The volunteers will be asked to complete an informed consent and undergo various assessments to determine their suitability for the study.
- Vaccination Phase: Volunteers will receive the study drug (vaccine) or placebo. They will be closely monitored before they are discharged and they will be given a symptom diary card to take home and fill for the next 7 days.
- The Quarantine (Challenge) Phase is where volunteers who are suitable will be admitted to the purpose-built quarantine facility in London. Further assessments will be undertaken to ensure their suitability. They will be given the study virus via the nostrils on study Day 0 and will remain in Quarantine for approximately 12 days after they have received the virus.
- Outpatient Phase: The participants will attend a follow-up on day 28 (±4) following discharge from quarantine. Their symptoms will be reassessed by a physician and a safety examination will be performed. Their final scheduled follow-up will be a telephone call 6 months post viral challenge.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0303
Date of REC Opinion
3 Oct 2017
REC opinion
Favourable Opinion