Trained Innate ImmunityPhase 4COPD-LIVENCT06257212
Live Vaccines and Innate Immune Training in COPD.
A Phase 4 study testing BCG vaccine (Danish strain 1331) and MMR Vaccine in people with Trained Innate Immunity and COPD, run by Josefin Eklöf at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Trained Innate Immunity, COPD
- What is being tested?
- BCG vaccine (Danish strain 1331) and MMR Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2024to 25 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Specialist verified and spirometry-confirmed COPD
- Age > 40 years.
- Negative HIV-test.
- Able to give informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine, Section of Respiratory Medicine
Hellerup, Copenhagen, 2900
About this study
Official title: Using Live Vaccines to Induce Beneficial Innate Immune Training and Reduce Systemic Inflammation in COPD Patients.
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.
Read the 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:
- MMR vaccine (M-M-R VaxPro)
- BCG vaccine (Danish strain 1331)
- Saline (placebo)
- Conditions
- Trained Innate Immunity, COPD
- Being tested
- BCG vaccine (Danish strain 1331), MMR Vaccine, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| BCG vaccine | Active comparator | Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months. Receives: Drug: BCG vaccine (Danish strain 1331) |
| MMR vaccine | Active comparator | Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months. Receives: Drug: MMR Vaccine |
| Placebo | Placebo comparator | Subcutaneous saline + intradermal saline at inclusion and after 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From inclusion to 4 months post-inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start28 Feb 2024
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trained Innate ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josefin Eklöf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josefin Eklöf, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Investigators
- Jens-Ulrik Stæhr S Jensen, MD,Phd, Principal investigator, Herlev Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257212
- Sponsor's protocol ID
- COPD-LIVE
- Acronym
- COPD-LIVE
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Live Vaccines to Induce Beneficial Innate Immune Training and Reduce Systemic Inflammation in COPD Patients.
- ClinicalTrials.gov ID
- NCT06257212
- Acronym / sponsor ID
- COPD-LIVE / COPD-LIVE
- Conditions
- Trained Innate Immunity, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Josefin EklöfUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- MMR vaccine (M-M-R VaxPro)
- BCG vaccine (Danish strain 1331)
- Saline (placebo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex.
| Arm | Type | Receives |
|---|---|---|
| BCG vaccine | Active comparator | Drug: BCG vaccine (Danish strain 1331)Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months. |
| MMR vaccine | Active comparator | Drug: MMR VaccineSubcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months. |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous saline + intradermal saline at inclusion and after 3 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Specialist verified and spirometry-confirmed COPD
- Age > 40 years.
- Negative HIV-test.
- Able to give informed consent.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG vaccine (Danish strain 1331)Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months. | Drug | BCG vaccine |
| MMR VaccineSubcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months. | Drug | MMR vaccine |
| PlaceboSubcutaneous saline + intradermal saline at inclusion and after 3 months. | Drug | Placebo |
Primary outcome
Innate immune training.
Time frame: From inclusion to 4 months post-inclusion.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens-Ulrik Stæhr S Jensen, MD,Phd principal investigator
Herlev Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BCG vaccine (Danish strain 1331) and MMR Vaccine in people with Trained Innate Immunity and COPD, run by Josefin Eklöf at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Innate immune training. (time frame: From inclusion to 4 months post-inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.