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COPD-2VAX: Enhancing Protection Against Respiratory Infections Through AS01-Mediated Innate Immune Activation in High-Risk Patients
EU CTIS ID: 2024-519163-18-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Immunocompromised status (primary, or secondary immunodeficiencies e.g., HIV, cancer therapy chemo, any medications that would suppress the immune system)
- 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.
- Previous illness with Gullain-Barré syndrome.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.