Live Vaccines and Innate Immune Training in COPD.

Phase 4

Recruiting

• Conditions: COPD; Trained Innate Immunity
• Interventions: Drug: BCG vaccine (Danish strain 1331); Drug: MMR Vaccine; Drug: Placebo

• Registration Number: NCT06257212
• Lead Sponsor: Josefin Eklöf

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.

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 Timeline

• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-13
• Study Start: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCG vaccine	BCG vaccine (Danish strain 1331)	Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.
MMR vaccine	MMR Vaccine	Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months.
Placebo	Placebo	Subcutaneous saline + intradermal saline at inclusion and after 3 months.

Primary Outcome Measures

Name	Time	Method
Innate immune training.	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.

Trial Locations

Locations (1)

Department of Internal Medicine, Section of Respiratory Medicine; 🇩🇰 Hellerup, Copenhagen, Denmark