RSV Vaccination to Reduce Recurrent AECOPD

Starting soon · Phase 4

Conditions studied: COPD, RSV

In brief

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.

Key facts

Study ID: NCT07508644
Run by: Chinese University of Hong Kong
People needed: 320
Starts: 2027-07-01
Expected to finish: 2030-12-31
Last updated by the study team: 2026-04-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)
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
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Pregnant or lactating (females not yet menopausal must have a negative pregnancy test before receiving the RSV vaccination)
Unable to provide informed consent

Where it is running

Prince of Wales Hospital — Shatin, Hong Kong

Full record on ClinicalTrials.gov

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