COPD-2VAX: Enhancing Protection Against Respiratory Infections Through AS01-Mediated Innate Immune Activation in High-Risk Patients
Key facts
- Where
- Hilleroed, DániaSee the site
- Phase
- 4. fázis
Where in Dánia
- Nordsjaellands HospitalHilleroed, DániaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nordsjaellands Hospital
- Trial code
- EU 2024-519163-18-00
- Record updated
- 2025. december 8.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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.