Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-02-28
2025-09-30
Brief Summary
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Detailed Description
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1. MMR vaccine (M-M-R VaxPro)
2. BCG vaccine (Danish strain 1331)
3. Saline (placebo)
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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BCG vaccine
Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.
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.
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.
Placebo
Subcutaneous saline + intradermal saline at inclusion and after 3 months.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age \> 40 years.
* Negative HIV-test.
* Able to give informed consent.
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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Josefin Eklöf
OTHER
Responsible Party
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Josefin Eklöf
MD, PhD
Principal Investigators
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Jens-Ulrik Stæhr S Jensen, MD,Phd
Role: PRINCIPAL_INVESTIGATOR
Herlev Gentofte Hospital
Locations
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Department of Internal Medicine, Section of Respiratory Medicine
Hellerup, Copenhagen, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COPD-LIVE
Identifier Type: -
Identifier Source: org_study_id
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