NCT06257212

Live Vaccines and Innate Immune Training in COPD.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Josefin Eklöf · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Trained Innate Immunity
• COPD

Interventions

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

Timeline

• Start date: 2024-02-28
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2024-02-13
• Last updated: 2026-03-19

Locations

1 site across 1 country: Denmark