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Live Vaccines and Innate Immune Training in COPD. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Live Vaccines and Innate Immune Training in COPD.

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

NCT06257212•Josefin Eklöf

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)

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Department of Internal Medicine, Section of Respiratory Medicine

Hellerup, Copenhagen, Denmark

Key Dates

Start Date

February 28, 2024

Primary Completion Date

August 25, 2025

Completion Date

August 25, 2025

Last Updated

March 19, 2026

Enrollment

ACTUAL participants

Conditions

Trained Innate ImmunityCOPD

Interventions

BCG vaccine (Danish strain 1331)

DRUG

MMR Vaccine

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Live Vaccines and Innate Immune Training in COPD.

Inclusion Criteria

Exclusion Criteria

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