Trained Innate Immunity, COPD
Conditions
Brief summary
A randomized, single-blinded clinical pilot study to assess whether vaccination with live attenuated vaccines can induce trained immunity and cause beneficial changes in patients with COPD.
Detailed description
Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex. A total of 60 participants will be recruited and randomly assigned with 20 in each treatment arm. Separated by three months, the participants will receive two doses of one of the following three treatments: 1. MMR vaccine (M-M-R VaxPro) 2. BCG vaccine (Danish strain 1331) 3. Saline (placebo)
Interventions
DRUGBCG vaccine (Danish strain 1331)
Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.
DRUGMMR Vaccine
Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months.
DRUGPlacebo
Subcutaneous saline + intradermal saline at inclusion and after 3 months.
Sponsors
Josefin Eklöf
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Specialist verified and spirometry-confirmed COPD * Age \> 40 years. * Negative HIV-test. * Able to give informed consent.
Exclusion criteria
* Acute febrile illness. * Known allergy to BCG or MMR vaccines or serious adverse effects at previous vaccination. * Allergy to MMR vaccine components, neomycin, or egg proteins. * Known prior, active, or latent infection with mycobacterium tuberculosis. * Pregnancy or breastfeeding. * Vaccination with a live vaccine within the last 4 weeks. * Being severely immunocompromised (HIV-1 infection, organ- or bone marrow transplantation, chemotherapy, primary immune defect, anti-cytokine therapy, immunosuppressant treatment). * Oral or intravenous corticosteroid at dose of ≥10 mg/day with duration over 3 months. * Active solid or non-solid malignancy or lymphoma, excluding basal cell carcinoma within 2 years. * Treatment with immunoglobulins within the last 3 months or expected treatment with immunoglobulins for the duration of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Innate immune training. | From inclusion to 4 months post-inclusion. | Innate immune training, detected as fold-changes in cytokine production capacity of innate immune cells for cytokines such as IL-1β, IL-6, IL-10, TNF-α and IFN-γ, following pro-inflammatory stimulation from inclusion to 4 months post-inclusion. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORJens-Ulrik Stæhr S Jensen, MD,Phd
Herlev Gentofte Hospital
Outcome results
None listed