Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
60
Countries
1
Sites
1
Chronic obstructive pulmonary disease
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.
Key facts
- Sponsor
- Gentofte Hospital, Gentofte Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Phenomena and Processes [G] - Cell Physiological Phenomena [G04], Phenomena and Processes [G] - Immune System Phenomena [G13]
- Trial duration
- 22 Feb 2024 → 25 Aug 2025
- Decision date (initial)
- 2023-12-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Karen Elise Jensen Foundation · Denmark's independent research council
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Prophylaxis, Pharmacodynamic
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 objectives 2
- 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.
Conditions and MedDRA coding
Chronic obstructive pulmonary disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10010952 | COPD | 10038738 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Main period The trial period
|
Randomised Controlled | Single | [{"id":56120,"code":1,"name":"Subject"}] | MMR: Will receive subcutaneous injections of MMR Vaccine (M-M-RVaxPro) and intradermal saline. BCG: Will receive subcutaneous injections of saline and intradermal BCG vaccine (Danish strain 1331). Placebo: Will receive subcutaneous injections of saline and intradermal saline. |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504519-34-00 | Using live vaccines to induce beneficial innate immune training and reduce systemic inflammation in COPD patients (COPD-LIVE) | Gentofte Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Must have specialist verified, spirometry-confirmed, COPD.
- Age > 40 years
- Able to give informed consent
Exclusion criteria 11
- Acute febrile ilness
- 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
- Oral or intravenous corticosteroid at a dose ≥10 mg/day over 3 months
- Cardiac arythmia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 6
- 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 3 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 1 to 3 months post- inclusion.
- Changes in blood levels of pro-inflammatory cytokines from inclusion to 3- and 4-months post- inclusion
- Changes in epigenetic markers of innate immune cells.
- Number of hospital admissions, number of COPD exacerbations, and mortality 12 months after inclusion
- Change in MRC, CAT and self-reported health from baseline to 12 months post-enrolment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD8028508 · Product
- Active substance
- Rubella Virus Wistar Ra 27/3 Strain (Live, Attenuated) Produced in WI-38 Human Diploid Lung Fibroblasts
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1.0 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BD52 — MORBILLI, COMBINATIONS WITH PAROTITIS AND RUBELLA, LIVE ATTENUATED
- Marketing authorisation
- EU/1/06/337/014
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BCG Vaccine "AJ Vaccines", pulver og solvens til injektionsvæske, suspension
PRD5459500 · Product
- Active substance
- Mycobacterium Bovis, Danish Strain 1331
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRADERMAL
- Max daily dose
- 0.1 ml millilitre(s)
- Max total dose
- 0.2 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AN01 — TUBERCULOSIS, LIVE ATTENUATED
- Marketing authorisation
- 14762
- MA holder
- AJ VACCINES A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1.5 ml millilitre(s)
- Max total dose
- 3.0 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Kildegaardsvej 28
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Jens Ulrik Stæhr Jensen
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Jens Ulrik Stæhr Jensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000002325
|
Frederiksberg, Denmark | On site monitoring |
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Gentofte Hospitalsvej 1
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-02-22 | 2025-08-25 | 2024-02-22 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-18 | Denmark | Acceptable 2023-12-11
|
2023-12-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-04 | Denmark | Acceptable 2024-04-03
|
2024-04-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-22 | Denmark | Acceptable 2024-04-23
|
2024-04-23 |