sing live vaccines to induce beneficial innate immune training and reduce systemic inflammation in COPD patients

Phase 1

Recruiting

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Chronic obstructive pulmonary disease; MedDRA version: 21.1Level: LLTClassification code: 10010952Term: COPD Class: 10038738; Therapeutic area: Phenomena and Processes [G] - Cell Physiological Phenomena [G04]; Therapeutic area: Phenomena and Processes [G] - Immune System Phenomena [G13]

• Registration Number: CTIS2023-504519-34-01
• Lead Sponsor: Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

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

Inclusion Criteria

Must have specialist verified, spirometry-confirmed, COPD., Age > 40 years, Able to give informed consent

Exclusion Criteria

Acute febrile ilness, Oral or intravenous corticosteroid at a dose =10 mg/day over 3 months, Cardiac arythmia, Blood dyscrasia, Known allergy to either the BCG or MMR vaccines or severe adverse effects during prior 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 4 weeks, Severe immunocompromisation (HIV-1 infection, organ- or bone marrow transplantation, chemotherapy, primary immune defect, anti-cytokine therapy, immunosuppressant treatment)., Active solid or non-solid malignancy or lymphona within 2 years, excluding basal cell carcinoma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the changes in the innate immune system of COPD patients upon vaccination with live vaccines and determine if vaccination induces trained immunity as reported previously in other populations.;Secondary Objective: To examine if vaccination with live vaccines causes changes in systemic inflammation, including eosinophilic inflammation., To compare the effects of the BCG vaccine with the MMR vaccine with regard to their effects on the innate immune system.;Primary end point(s): 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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):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 3 to 4 months post- inclusion.;Secondary end point(s):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 1 to 3 months post- inclusion.;Secondary end point(s):Changes in blood levels of pro-inflammatory cytokines from inclusion to 3- and 4-months post- inclusion;Secondary end point(s):Changes in epigenetic markers of innate immune cells.;Secondary end point(s):Number of hospital admissions, number of COPD exacerbations, and mortality 12 months after inclusion;Secondary end point(s):Change in MRC, CAT and self-reported health from baseline to 12 months post-enrolment.