RSV Vaccination to Reduce Recurrent AECOPD

NCT07508644 | Not Yet Recruiting Phase 4

• 1 other identifier: RSVVaccine_AECOPD
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; RSV

Keywords

AECOPD; RSV; Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of all-cause moderate-to-severe AECOPD

  Comparison of the number of all-cause moderate-to-severe AECOPD between the RSV and SOC groups over 1 year

  1 year

Secondary Outcomes (7)

• Number of all-cause severe AECOPD

  1 year

• Number of moderate-to-severe and severe AECOPD with RSV infection

  1 year

• Time to first all-cause moderate-to-severe and severe AECOPD

  1 year

• Time to first moderate-to-severe and severe AECOPD with RSV infection

  1 year

• Change in post-bronchodilator forced expiratory volume in 1 second (FEV1)

  1 year

Study Arms (2)

RSV group

ACTIVE COMPARATOR

Patients who will receive RSV vaccination and standard of care

Biological: RSV vaccination (Arexvy, GlaxoSmithKline)

Standard of care (SOC) group

NO INTERVENTION

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

Interventions

RSV vaccination (Arexvy, GlaxoSmithKline) BIOLOGICAL

A single dose of RSV vaccination (Arexvy, GlaxoSmithKline) at the start of study

RSV group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

arexvy; halofantrine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ka Pang Chan, MBChB

CONTACT

35052211; chankapang@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a multi-center, two-arm, open-label, prospective study including COPD frequent exacerbators despite dual long-acting bronchodilators (LABD). Eligible patients will be allocated in a 1:1 ratio to receive either RSV vaccination or no RSV vaccination, in addition to guideline-directed standard COPD care. The occurrence of AECOPD will be recorded according to predefined criteria. The incidence of RSV infection will be captured by objective virological testing. RSV-specific antibody in the plasma will be measured throughout the study period. This study will follow patients for 1 year after recruitment. Important endpoints include reductions in all-cause and RSV-specific moderate-to-severe AECOPD, and changes in plasma RSV-specific antibody over 1 year.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)