Study to understand if a vaccine can prevent flare ups of your COPD
Research type
Research Study
Full title
A Phase IIB, randomised, observer-blind, placebo-controlled, multi-centre study to evaluate the efficacy, safety, reactogenicity and immunogenicity of the GSK Biologicals’ investigational vaccine GSK3277511A when administered intramuscularly according to a 0, 2 months schedule in COPD patients aged 40 to 80 years with a previous history of acute exacerbation (AECOPD).
IRAS ID
230430
Contact name
Tom Wilkinson
Contact email
Sponsor organisation
GSK Vaccines
Eudract number
2017-000880-34
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
Study to understand if a vaccine can prevent flare ups of your COPD\n\nChronic Obstructive Pulmonary Disease (COPD) describes a collection of diseases which make breathing gradually more difficult. At the beginning of the disease, the difficulty in breathing is only noticeable when exercising, but over the years it gradually becomes worse. Patient’s condition can also rapidly worsen (this is called a COPD exacerbation). The exacerbations can be very serious. Patients may require medical treatment and could be admitted to hospital.\n\nCOPD exacerbations are often caused by infection of the lungs. This study, funded by GlaxoSmithKline, is investigating a vaccine which could protect from two of the most common species of bacteria responsible for lung infections in COPD; nontypeable Haemophilius influenzae (NTHI) and Moraxella catarrhalis (Mcat). The aim of the study is to reduce the number of exacerbations in COPD patients. \n\nThere is currently no vaccine available for prevention of COPD exacerbations.\n\n600 COPD patients(around 60 recruited from 6 UK centres) with a past history of exacerbation (s) will be asked to participate in the study. Patients will be given two doses of either vaccine or placebo (dummy vaccine). Patients will be asked to attend regular visits at their hospital to check their health (~9 visits over 15 months), which include lung function testing and blood sampling. In addition patients will record their daily health in an electronic diary (similar to an iPad). The electronic diaries will be reviewed by a doctor. If doctors will believe that the patients’ condition is worsening, the patients will be asked to come into the hospital and see the doctor.\nPatients will be asked to provide samples of their phlegm (if they can) so so we can analyze the effect of the vaccine.\n
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1461
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion