RSV Vaccination to Reduce Recurrent AECOPD

Conditions

• COPD
• RSV

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

First listed

Apr 2, 2026

Start date

Jul 1, 2027

Status verified

Apr 2026

Primary completion

Jun 30, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

320 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: RSV group
  Patients who will receive RSV vaccination and standard of care
• No Intervention: Standard of care (SOC) group
  Patients who will receive standard of care (no RSV vaccination)

Primary Outcome Measure

Number of all-cause moderate-to-severe AECOPD [ Time Frame: 1 year ]

Central Contacts

• Ka Pang Chan, MBChB
  35052211
  [email protected]

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