STABILISE

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).

Participants will be randomised in a 1:1 ratio between the two arms of the study and will be followed up for 12 months. 

The overall aim of this research is to determine whether the Bacillus Calmette–Guérin (BCG) vaccination reduces rates of moderate-severe acute exacerbations of chronic obstructive pulmonary disease AECOPD at 12 months in patients who have a clinical diagnosis of COPD, and a history of exacerbation in the preceding year.

50 Primary and Secondary care sites across the United Kingdom. 

INCLUSION CRITERIA:

1. Adults age ≥ 18 years

2. a primary clinical diagnosis of COPD

3. ≥2 acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in the last 12 months prior to screening

EXCLUSION CRITERIA:

1. Positive or indeterminate Interferon-Gamma Release Assay (IGRA)

2. Immunosuppression

3. Received >20mg prednisolone per day for >14 days in the last 3 months

4. Known pregnancy

5. Allergic reaction to BCG

6. Unable to give informed consent

 Participants will be randomly allocated to go into one of two groups: 

Group 1: Participants will receive the BCG vaccine.

Group 2: Participants will not receive the vaccine.

There are a large number of objectives:

PRIMARY OUTCOMES:

1. Rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) (number per person per year) over 12 months follow up from IMP administration date (or from the date of randomisation if no treatment was administered)

 SECONDARY OUTCOMES:

1. Hospitalisation rate for AECOP
2. Quality of life (QOL), as defined by the CAT score
3. Number of days antibiotic therapy, whether for respiratory or other causes
4. Number of days oral steroid therapy for AECOPD

EXPLORATORY/ MECHANISTIC:

1. BCG vaccine-specific responses comprised of trained immunity, gene expression analyses, cell phenotyping and functional screening.

QUALITATIVE ACCEPTABILITY STUDY

1. To explore the understanding and acceptance of vaccines in general, and of this specific vaccine, exploring and comparing uptake/acceptability to other exacerbation prevention strategies, for both patients and healthcare professionals. 

If you are interested in taking part in the STABILISE trial and require more information, contact the trials team

Email: STABILISE@trials.bham.ac.uk

Telephone: 0121 415 9123