2024-519163-18-00Not yet recruitingPhase 4
COPD-2VAX: Enhancing Protection Against Respiratory Infections Through AS01-Mediated Innate Immune Activation in High-Risk Patients
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Dec 2025
Brief summary (registry, in English)
This study aims to evaluate the specific and non-specific effects of innate immune activation induced by the AS01-adjuvanted RSV vaccine in individuals at high risk for severe respiratory disease and insufficient vaccine response. Our specific objectives are: 1. To investigate whether the AS01-adjuvanted RSV vaccine induces potent mucosal and systemic innate responses in COPD patients aged ≥ 60 years. 2. To evaluate whether ipsi- and/or contralateral co-administration with PCV20 enhances the vaccine-specific adaptive immune response to pneumococcal antigens. 3. To assess non-specific effects of the AS01-adjuvanted RSV vaccine regarding a) the duration of innate enhancement that affects adaptive responses using a controlled delayed vaccine-coadministration model, b) mucosal protection against viral and bacterial respiratory pathogens, and c) sustained systemic control of viral replication in chronic or latent infections.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Sept 2025
- Start date
- 1 Sept 2025
- Lead sponsor
- Nordsjaellands Hospital
- Diseases
- COPD
- EU CT number
- 2024-519163-18-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 60 or older with COPD who need hospital outpatient care and had a PPV23 vaccine more than one year ago.
- Age
- 60 years or older
- Sex
- Women and men can both join.
- Disease stage
- A COPD diagnosis confirmed by a lung specialist, needing care at the hospital outpatient clinic.
- Earlier treatment
- Must have had the PPV23 vaccine more than one year before joining. Must never have had any PCV or RSV vaccine.
Main reasons for not taking part
- Weakened immune system, for example HIV, cancer chemotherapy or medicines that suppress the immune system
- Any earlier PCV or RSV vaccine
- Acute illness in the past 14 days, including COPD flare-ups and fever
- Any other vaccine in the past four weeks
- Allergy to an ingredient of the trial medicine
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of any PCV or RSV vaccine at any time
- Acute illness within the previous 14 days (including COPD exacerbations and fever)
- Receipt of any other vaccine within the last four weeks
- Allergens towards one of the ingredients in the trial medication.
Other illness
- Immunocompromised status (primary, or secondary immunodeficiencies e.g., HIV, cancer therapy chemo, any medications that would suppress the immune system)
- Previous illness with Gullain-Barré syndrome.
Who the study is looking for
- A confirmed COPD diagnosis by a respiratory medicine specialist requiring attention at the hospital's outpatient clinic
- Age≥60 years
- Previous PPV23 vaccination more than one year before inclusion
- Volunteer agrees to participate in all aspects of the trial and has signed the informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nordsjaellands Hospital | Hilleroed | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.