sing influenza vaccination to understand and improve immune responses to vaccination in patients with chronic obstructive pulmonary disease (COPD) and healthy older people.

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; Influenza viral disease; Respiratory - Chronic obstructive pulmonary disease; Infection - Other infectious diseases

• Registration Number: ACTRN12620000830998
• Lead Sponsor: Princess Alexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-30
• Study Start: 2020-08-21
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Mild to very Severe COPD with a post bronchiodilater FEV1 less than 80% predicted FEV1 /FVC ratio less than 0.7. COPD patients will be stable with no COPD exacerbations or respiratory infections within the last 4 weeks.
Healthy controls no prior or current symptoms of lung disease, MRC dyspnoea scale less than 2 and normal spirometry. And normal spirometry with an FEV1 and FVC within normal range.

Exclusion Criteria

Invasive malignancy within the last 2 years.
Renal impairment (eGFR less than 40ml/min).
Acute febrile illness with fever greater than 38.5 dC.
Hypersensitivity to egg protein.
Use of oral Prednisolone (or equivalent) greater than or equal to 10mg per day.
Use of other systemic immunosuppressive therapy.
Anaphylaxis following a previous dose of influenza vaccine.
Anaphylaxis following a vaccine component (including eggs).
History of Guilliane Barre within 6 weeks of a previous influenza vaccination

Cardiac disease, diabetes mellitus and superficial non- melanoma skin cancers WILL NOT be exclusion criteria provided these are stable and well controlled in the opinion of the investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of influenza vaccine recipients achieving antibody levels that connote protection against specific influenza vaccine antibody strains. Individual study participant serum antibody levels will be assessed via haemaglutination inhibition assay for specific influenza strains. [Baseline, 24hrs, 7 days, 28 days and 90 days post initial influenza vaccine.]

Secondary Outcome Measures

Name	Time	Method
Measure cellular phenotype, in particular dendritic, B-cell and T-cell populations, to identify differences between COPD and healthy participants in response to influenza vaccine.<br>Changes in immune cell numbers will be assessed by flow cytometry. To determine the quantity and isotype of B cells elicited, influenza-specific B cells were identified using recombinant HA (rHA) probes and assessed by flow cytometry [Baseline, 24hrs, 7 days, 28 days and 90 days post initial Influenza Vaccine.];Identification of deferentially expressed genes that differ between COPD and healthy participants in response to the influenza vaccine, via RNASeq. [Baseline, and 24hrs post initial influenza vaccine.]