Live Vaccines and Innate Immune Training in COPD. (COPD-LIVE)

Using Live Vaccines to Induce Beneficial Innate Immune Training and Reduce Systemic Inflammation in COPD Patients.

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.

Study Overview

• Status: Completed
• Conditions: COPD; Trained Innate Immunity
• Intervention / Treatment: Drug: BCG vaccine (Danish strain 1331); Drug: MMR Vaccine; Drug: Placebo

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)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hellerup, Copenhagen, Denmark, 2900
      • Department of Internal Medicine, Section of Respiratory Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BCG vaccine; Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.	Drug: BCG vaccine (Danish strain 1331); Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.
Active Comparator: MMR vaccine; Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months.	Drug: MMR Vaccine; Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months.
Placebo Comparator: Placebo; Subcutaneous saline + intradermal saline at inclusion and after 3 months.	Drug: Placebo; Subcutaneous saline + intradermal saline at inclusion and after 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Innate immune training.	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.	From inclusion to 4 months post-inclusion.

Collaborators and Investigators

• Sponsor: Josefin Eklöf
• Investigators: Principal Investigator: Jens-Ulrik Stæhr S Jensen, MD,Phd, Herlev Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): August 25, 2025
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Biological Products; Complex Mixtures; Bacterial Vaccines; Vaccines; Vaccines, Combined; Tuberculosis Vaccines; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; BCG Vaccine; Measles-Mumps-Rubella Vaccine
• Other Study ID Numbers: COPD-LIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No