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OpenTrials
Completed

NCT Number: NCT06257212

Live Vaccines and Innate Immune Training in COPD.

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.

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Key information

Conditions

Trained Innate Immunity COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Internal Medicine, Section of Respiratory Medicine

Hellerup, Copenhagen, 2900, Denmark

About this study

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:

  • MMR vaccine (M-M-R VaxPro)
  • BCG vaccine (Danish strain 1331)
  • Saline (placebo)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCG vaccine (Danish strain 1331)

Drug

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

MMR Vaccine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Innate immune training.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Josefin Eklöf

Other

Registry information

Official study title

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

Acronym: COPD-LIVE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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