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Not yet taking people in Hong KongPhase 4

RSV vaccine tested in people with COPD who have frequent flare-ups

Tests an RSV vaccine in adults with COPD and repeated flare-ups.

Key facts

Who runs it
Chinese University of Hong Kong
Where
Shatin, Hong KongSee the site
Trial code
Registry title
RSV Vaccination to Reduce Recurrent AECOPD
Status
Not yet recruiting
Phase
Phase 4
People taking part
320 people, planned
Starts
1 Jul 2027
Expected to end
31 Dec 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • RSV vaccination (Arexvy, GlaxoSmithKline)
Record updated
13 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 or older with COPD who have had repeated flare-ups despite taking two long-acting inhalers. It tests whether an RSV vaccine reduces flare-ups.

Age
50 years or older
Sex
All sexes can join.
Disease stage
COPD with airflow blockage on a breathing test (post-bronchodilator FEV1/FVC <0.70). At least 2 moderate or 1 severe flare-up in the 12 months before screening.
Earlier treatment
Must be on two long-acting inhalers (LABA and LAMA) in the same device for 8 weeks or more. Flu and pneumococcal vaccines must be up to date, given at least 1 month before screening. Must not have had any RSV vaccine before.
Biomarker or test result
Current or former smoker with at least 10 pack-years of smoking.

Main reasons for not taking part

  • Another lung disease that mainly causes the symptoms, such as asthma or bronchiectasis
  • Life expectancy under 1 year because of a serious or unstable illness
  • Weak immune system, or long-term steroid use (10mg/day prednisolone or equivalent for 2 weeks or more)
  • Allergy or reaction to any part of the vaccine
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Hong Kong

  • Prince of Wales HospitalShatin, Hong KongContact: Ka Pang Chan, MBChBNo longer taking part

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • RSV groupExisting treatment, for comparison

    Patients who will receive RSV vaccination and standard of care

    Treatment: RSV vaccination (Arexvy, GlaxoSmithKline)

  • Standard of care (SOC) groupNo study treatment, for comparison

    Patients who will receive standard of care (no RSV vaccination)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Open-label, Multicenter Trial of RSV Vaccination to Reduce Moderate-to-severe Exacerbations in COPD Frequent Exacerbators: Clinical Effectiveness and RSV-specific Immune Responses
Plain-language title
RSV vaccine tested in people with COPD who have frequent flare-upsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
13 April 2026