STABILISE
Research type
Research Study
Full title
STABILISE: a multicentre, randomised, parallel group, superiority trial to investigate the use of BCG vaccine in altering immune response and exacerbation in chronic obstructive pulmonary disease (COPD)
IRAS ID
1007306
Contact name
Alice Turner
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN62785249
Research summary
The vaccine for tuberculosis (BCG) has been in use to prevent this disease for over 100 years. More recently studies have shown that in both adults and children, giving this vaccine can result in other benefits, including helpful changes within the immune system that can protect against many other infections, and may prevent hospital admissions in older people as a result. Studies on these effects, sometimes referred to as “trained immunity” have been small, and we do not know if the effect is true until properly designed studies have been done. The main benefit of BCG seems to be on rates of chest infections, which are more common in people who have a lung disease already, such as chronic obstructive pulmonary disease (COPD). Flare ups of lung disease are usually called exacerbations, and are mainly (but not always) due to infection. Preventing exacerbations in people with lung disease is particularly important because frequent infections can cause lung disease to progress, and every time an infection happens quality of life may get worse. Using the BCG vaccine as a means of prevention in such people could therefore be helpful for long term health by breaking the vicious cycle of recurrent exacerbations and progressive lung pathology .The STABILISE trial will enrol 804 patients who have COPD, and who have had at least two exacerbations in the last 12 months. We will recruit in hospitals and GP practices. Half of the patients will receive the vaccine, and half will not. Patients will then be followed up for a year and their rate of exacerbations compared. We will also study symptoms, quality of life and hospital admissions in the two groups. To understand how the vaccine works, we will send tests at enrolment, and at 1 year to look at the function of the immune system. Patients will also send tests at the time of exacerbation from their own home - these will look for the presence of viruses and bacteria.
REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0027
Date of REC Opinion
18 Feb 2025
REC opinion
Further Information Favourable Opinion