RSV PED-001
Research type
Research Study
Full title
A Phase I, randomised, observer-blind, controlled study to evaluate the 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 according to a 0, 1 month schedule to healthy adults aged 18 to 45 years.
IRAS ID
174150
Contact name
Matthew Snape
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals
Eudract number
2014-005333-31
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This is a phase 1, first in human study to investigate the safety of the RSV vaccine and understand how well the vaccine is tolerated. The study will also look at how well the vaccine triggers the body to produce antibodies and immune cells that are capable of killing RSV and it will give some indication of how likely the vaccine is to offer protection against RSV.
Since this is the first time the RSV vaccine is being given to people, the study will be conducted in 3 steps to make sure participants are safe when taking part. In this study, 2 different doses (low and high) of the ChAd155-RSV vaccine will be tested against 2 controls, a MenB vaccine and placebo. Out of the 72 people who take part in this study, 16 will go in the first step. The low dose of the RSV vaccine will be tested in this step. Another 16 will go in the second step and 40 other people will go in the third step. The high dose of the RSV vaccine will be tested in the second and third steps. In total, about 40 people will receive the RSV vaccine (8 people will receive the low dose and about 32 people will received the high dose), about 16 will receive the MenB vaccine and about 16 will receive placebo.
This study will last about 12 months and participants would need to visit the clinic at least 12 times. Two vaccinations will be given by injection around 4 weeks apart in the study at Visits 1 and 5. Other study procedures performed during the study visits will include blood sampling, physical examination, urine tests, nasal swab (if deemed necessary), and pregnancy testing (if applicable). The participants will also need to complete patient diaries on how they are feeling and any medications they are taking.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0133
Date of REC Opinion
6 May 2015
REC opinion
Further Information Favourable Opinion