NCT07508644Not yet recruitingPhase 4
RSV Vaccination to Reduce Recurrent AECOPD
Open-label, Multicenter Trial of RSV Vaccination to Reduce Moderate-to-severe Exacerbations in COPD Frequent Exacerbators: Clinical Effectiveness and RSV-specific Immune Responses
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
Objectives: To determine whether respiratory syncytial virus (RSV) vaccination reduces the rate of all-cause moderate-to-severe acute exacerbations of COPD (AECOPD) in high-risk patients, and to characterise RSV-specific infection and immune responses in this population. Hypothesis: RSV vaccination in COPD frequent exacerbators receiving dual long-acting bronchodilators will reduce all-cause moderate-to-severe AECOPD by at least 20-25% over 12 months. Design and subjects: This multicentre, two-arm, open-label, prospective study will recruit 320 COPD patients with 2 moderate or severe AECOPD in the prior year despite dual long-acting bronchodilator therapy. Eligible subjects will be allocated 1:1 to receive RSV vaccination plus standard care or standard care alone and followed for 12 months. Interventions: Participants in the vaccine arm will receive a single dose of a licensed RSV vaccine in addition to usual COPD management. Controls will receive usual care without RSV vaccination during the study period. Main outcome measures: The primary outcome is the rate of all-cause moderate-to-severe AECOPD per patient-year. Secondary outcomes include RSV-positive AECOPD, RSV infection incidence confirmed by virological testing, severe AECOPD requiring hospitalisation, time to first moderate-to-severe AECOPD, and changes in plasma RSV-specific antibody titres over 12 months. Data analysis and expected results: Exacerbation rates will be compared between groups using negative binomial regression with adjustment for key covariates on an intention-to-treat basis. The investigators expect RSV vaccination to achieve a clinically meaningful (20%) reduction in all-cause moderate-to-severe AECOPD and to provide mechanistic insights linking RSV immunity, RSV infection, and exacerbation risk in COPD frequent exacerbators.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 27 Mar 2026
- Start date
- 1 Jul 2027
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- COPD
- NCT number
- NCT07508644
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 320
- From 1 Jul 2027 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Refused to receive RSV vaccine (for the RSV group only)
- Received RSV vaccine of any brand before
- Immunocompromised or long-term steroid user (≥10mg/day prednisolone or equivalent for ≥2 weeks), which may affect the RSV vaccine efficacy
- Pregnant or lactating (females not yet menopausal must have a negative pregnancy test before receiving the RSV vaccination)
Other illness
- Coexisting significant pulmonary disease predominating the respiratory symptoms (e.g. asthma, bronchiectasis)
- Life expectancy shorter than 1 year due to serious or unstable chronic illness (e.g. advanced lung cancer)
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Other
- Unable to provide informed consent
Who the study is looking for
- Age 50 years or older
- Spirometry evidence of airflow obstruction (post-bronchodilator FEV1/FVC \<0.70)
- Current or former smoker who had accrued a ≥10 pack-year smoking history
- Frequent COPD exacerbator, as defined by at least ≥2 moderate or ≥1 severe AECOPD in the 12 months prior to screening \[31,32\]
- On dual LABD (LABA and LAMA) using the same inhaler/device for ≥8 weeks
- Up-to-date influenza and pneumococcal vaccination received at least 1 month prior to screening
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.