RSV vaccine tested in people with COPD who have frequent flare-ups
Tests an RSV vaccine in adults with COPD and repeated flare-ups.
Plain-language title generated from the registry record
Registry title: RSV Vaccination to Reduce Recurrent AECOPD
Key facts
- Where
- Shatin, Hong KongSee the site
- Phase
- Phase 4
Where in Hong Kong
- Prince of Wales HospitalShatin, Hong KongNo longer taking part
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
- Chinese University of Hong Kong
- Trial code
- NCT07508644
- Record updated
- 13 April 2026
- Original description
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.Read full original descriptionShow less
Open-label, Multicenter Trial of RSV Vaccination to Reduce Moderate-to-severe Exacerbations in COPD Frequent Exacerbators: Clinical Effectiveness and RSV-specific Immune Responses
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.
Inclusion: 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.
Exclusion: 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); 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; Unable to provide informed consent.