Preventing NTHi-MCat Infection, a major cause of AECOPD
Research type
Research Study
Full title
A Phase 2, randomised, observer-blind, multi-centre study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' GSK3277511A investigational vaccine when administered intramuscularly according to different vaccine schedules in adults aged 40 to 80 years old.
IRAS ID
235743
Contact name
Mark Blagden
Contact email
Sponsor organisation
GSK
Eudract number
2017-002941-31
Clinicaltrials.gov Identifier
16531, Investigational New Drug (IND) number; PUBL 34908, NIHR CRN Reference
Duration of Study in the UK
2 years, 2 months, 28 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a disease that limits airflow to the lungs. COPD patients have daily breathing difficulties and are dependent on medication. Smoking is a common cause of COPD. During a flare up, or “exacerbation” breathing difficulties worsen to the point where it can feel like you’re suffocating. Frequent exacerbations can lead to higher hospitalisations, morbidity and mortality.
Non-typeable Haemophilius influenzae (NTHi) and Moraxella catarrhalis (Mcat) are two of the most common bacteria identified to cause exacerbations. The availability of a vaccine for the prevention of NTHi and Mcat infection could protect COPD patients from developing exacerbations.A new vaccine to prevent bacterial infections caused by NTHi and Mcat is being developed by GlaxoSmithKline (GSK). This GSK funded multi-centre study evaluates safety of a 3rd dose of the vaccine either given at 6 months or at 12 months after the first dose. Approximately 200 healthy adult smokers (former and current) in total (~50 recruited from GP’ sites in UK) aged 40 to 80 years old will be recruited into this study.
During this 10 visit study (participation lasts about 2 years in total), participants will be randomly allocated to one of two groups. All participants will receive four injections at different timepoints: three doses of the NTHi-Mcat study vaccine and one dose of placebo. Study is blinded so participants don’t know which injection is a placebo. 8 blood samples will be drawn from all participants for measuring the immune response.
Baseline assessments will include: demographic data, medical history, smoking status, smoking history, height, weight, physical exam, urine pregnancy test (if applicable), pre-vaccination body temperatures.
Participants will be observed for 60 minutes after each vaccination and phone calls made 7 days after each vaccination visit. Participants will report any reactions experienced so that we can get an understanding of the vaccine safety.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0450
Date of REC Opinion
16 Jan 2018
REC opinion
Further Information Favourable Opinion