Preventing severe respiratory illness in infants caused by winter RSV
Research type
Research Study
Full title
A Phase 1/2, randomized, observer-blind, controlled,multi-center study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV)(GSK3389245A), when administered intramuscularly as a single dose or as two doses according to a 0, 1-month schedule, to infants aged 6 and 7 months.
IRAS ID
256597
Contact name
Prof. Saul Faust
Contact email
Sponsor organisation
GSK
Eudract number
2018-000431-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Investigational New Drug number, 16999; CHIL , 35559
Duration of Study in the UK
2 years, 5 months, 18 days
Research summary
Respiratory Syncytial Virus (RSV) is a leading cause of lower airway infections in babies and a common cause of hospital admissions (approximately 31/1000 babies under 6 months) in children under 5 years of age. Babies below 6 months of age are at highest risk. There is no effective treatment for RSV infection and no vaccine to prevent it.
A new RSV vaccine is being developed. This GlaxoSmithKline funded study aims to find out if the new RSV vaccine is safe, well tolerated and protects against RSV infection.
This study will be conducted in hospitals around the world including UK. Approximately 150 healthy babies aged 6 and 7 months of age will take part in this study, attending 8 or 9 study visits and followed by researchers for about 2 years.
Eligible participants will be randomly assigned to one of three groups:
• A group that will receive 1 dose of RSV vaccine,
• A group that will receive 2 doses of RSV vaccine
• A control group that will receive either a placebo (a dummy vaccine) or another, commonly used and licensed vaccine if available in participating country.In UK the control group will receive placebo.
All participants will receive 2, 4 or 5 injections (2 in UK) in total depending on the control group vaccine. The study is blinded so parents don’t know which injection is placebo.
Participants will undergo a range of clinical assessments and safety monitoring. Blood and nasal samples will be taken at specific visits during the study to check the health of baby, whether baby had RSV before joining the study, to measure the immune response to the RSV vaccine, and to check whether baby respiratory illness is due to RSV. Parents will be asked to report any reactions experienced so that we can get an understanding of the vaccine safety.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0157
Date of REC Opinion
17 May 2019
REC opinion
Further Information Favourable Opinion