Live Vaccines and Innate Immune Training in COPD.

NCT06257212 | Completed Phase 4

• 1 other identifier: COPD-LIVE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Trained Innate Immunity

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

BCG vaccine

ACTIVE COMPARATOR

Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.

Drug: BCG vaccine (Danish strain 1331)

MMR vaccine

ACTIVE COMPARATOR

Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months.

Drug: MMR Vaccine

Placebo

PLACEBO COMPARATOR

Subcutaneous saline + intradermal saline at inclusion and after 3 months.

Drug: Placebo

Interventions

MMR Vaccine DRUG

Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months.

MMR vaccine

BCG vaccine (Danish strain 1331) DRUG

Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.

BCG vaccine

Placebo DRUG

Subcutaneous saline + intradermal saline at inclusion and after 3 months.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Specialist verified and spirometry-confirmed COPD
• Age \> 40 years.
• Negative HIV-test.
• Able to give informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Josefin Eklöf: lead

Study Sites (1)

Department of Internal Medicine, Section of Respiratory Medicine

Hellerup, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BCG Vaccine; Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• Jens-Ulrik Stæhr S Jensen, MD,Phd

  Herlev Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 13, 2024
• Study Start: February 28, 2024
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

DK (1)