Live Vaccines and Innate Immune Training in COPD.

Josefin Eklöf60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Trained Innate Immunity COPD

Interventions

BCG vaccine (Danish strain 1331)DRUG

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

MMR VaccineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: From inclusion to 4 months post-inclusion.

Data from ClinicalTrials.gov

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