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

Immunogenicity of the influenza vaccination in patients with chronic obstructive pulmonary disease (COPD).

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000830998

Acronym

IVC

Enrollment

171

Registered

2020-08-21

Start date

2015-04-13

Completion date

2017-06-08

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Influenza infection is a frequent and important problem in chronic obstructive pulmonary disease (COPD). Influenza can have severe consequences in these patients, leading to acute exacerbations of COPD, pneumonia and respiratory failure. COPD patients are thus recognised as a group at particular risk of influenza, and current guidelines recommend yearly influenza vaccination. These recommendations are largely based on expert opinion and observational studies, with very few randomised controlled trials having been conducted in COPD. It has been suggested that people with COPD may have an aberrant immune response to influenza viruses, and as such, they may be less able to effectively mount an immune response to influenza vaccination. This study will examine influenza vaccination in people with COPD, and healthy age-matched controls, focussing on the factors that predict an effective antibody response to the vaccine (seroprotection), especially aspects of dendritic cell and T-cell function. We will conduct an open-label observational study of seasonal influenza vaccine in 108 COPD patients and 108 healthy, age-matched control subjects. Subjects will receive a single dose of inactivated and purified split influenza vaccine in the autumn of 2015, 2016 and 2017. Primary outcomes of this study will be the proportion of vaccine recipients who achieve seroprotection or seroconversion.

Interventions

Open label, observational study of seasonal influenza vaccination in COPD patients and healthy age-matched control subjects. COPD patients will be recruited over three (3) seasonal influenza vaccine years, with each year considered a separate cohort. Some patients will be repeat participants, however, they will be considered individual participants for separate years due to differences in age and physical parameters that occur in the course of one year. COPD patients will provide an initial single blood sample to be analysed of no more than 50ml, prior to receiving a single standard dose of inactivated and purified influenza vaccine in autumn of 2015, 2016, 2017. COPD patients will provide further single blood samples 24h post inoculation (p.i.) of no more 2.5ml, 7 and 28 days p.i. of no more than 40ml and 90 day p.i. of no more than 10ml. COPD patients will be asked to attend three (3) mandatory study clinic visits, including administration of seasonal vaccine, with a additional 2 study clinic visits (days 7 and 90 p.i) being optional.

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Yes

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.

Outcome results