Live Vaccines and Innate Immune Training in COPD.

COPD Clinical Trial

— COPD-LIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257212
• Other study ID #: COPD-LIVE
• Status: Recruiting
• Phase: Phase 4
• Start date: February 28, 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Contact: Josefin Eklöf, MD,Phd
• Phone: +4538673555
• Email: josefin.viktoria.ekloef[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Internal Medicine, Section of Respiratory Medicine	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Josefin Eklöf

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Innate immune training.	Innate immune training, detected as fold-changes in cytokine production capacity of innate immune cells for cytokines such as IL-1ß, IL-6, IL-10, TNF-a and IFN-?, following pro-inflammatory stimulation from inclusion to 4 months post-inclusion.	From inclusion to 4 months post-inclusion.