Vaccination with live vaccines to improve immune response in COPD patients
Using Live Vaccines to Induce Beneficial Innate Immune Training and Reduce Systemic Inflammation in COPD Patients.
This study is testing if live vaccines can boost the immune system and improve health in people with COPD.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Chronic Obstructive Pulmonary Disease Trial Network, Denmark Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hellerup, Copenhagen) |
| Trial ID | NCT06257212 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates whether live attenuated vaccines can enhance innate immunity in patients with chronic obstructive pulmonary disease (COPD). It is a randomized, single-blinded trial involving 60 participants who will receive either the MMR vaccine, the BCG vaccine, or a saline placebo in a controlled setting. Participants will be stratified by sex and receive two doses of their assigned treatment three months apart. The goal is to assess the potential benefits of vaccination on immune response and overall health in COPD patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 40 years old with specialist-verified and spirometry-confirmed COPD.
Not a fit: Patients with acute febrile illness, severe immunocompromised conditions, or known allergies to the vaccines will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved immune function and health outcomes for patients with COPD.
How similar studies have performed: While the concept of trained immunity is gaining interest, this specific approach using live vaccines in COPD patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hellerup, Copenhagen
- Department of Internal Medicine, Section of Respiratory Medicine — Hellerup, Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens-Ulrik Stæhr S Jensen, MD,Phd — Herlev Gentofte Hospital
- Study coordinator: Josefin Eklöf, MD,Phd
- Email: josefin.viktoria.ekloef@regionh.dk
- Phone: +4538673555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.