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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCG vaccine | Active Comparator | Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months. |
|
| MMR vaccine | Active Comparator | Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months. |
|
| Placebo | Placebo Comparator | Subcutaneous saline + intradermal saline at inclusion and after 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG vaccine (Danish strain 1331) | Drug | Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From inclusion to 4 months post-inclusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens-Ulrik Stæhr S Jensen, MD,Phd | Herlev Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Section of Respiratory Medicine | Hellerup | Copenhagen | 2900 | Denmark |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex.
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| MMR Vaccine | Drug | Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months. |
|
| Placebo | Drug | Subcutaneous saline + intradermal saline at inclusion and after 3 months. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045424 |
| Complex Mixtures |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |