Clinical trial NCT02900209: Influenza Vaccination and COPD Phenotypes
Official title: Responses of the Immune System to Influenza Vaccination in Phenotypes of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Influenza
Exacerbations
Lead sponsor: University of Lincoln
Sponsor class: OTHER
Collaborators: name: University of Kent
name: NHS Lincolnshire West Clinical Commissioning Group
name: NHS South Lincolnshire Clinical Commissioning Group
First posted: 2016-09-14
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 65-85 years with a diagnosis of COPD (according to Global Initiative for Chronic Obstructive Lung Disease criteria: post bronchodilator FEV1/FVC ratio \<0.70) and moderate to severe airflow limitation (FEV1 30-80% predicted) will be approached.

We will also include healthy participants as a control reference group who are aged 65-85 years without symptoms of lung disease and have normal spirometry.

Brief summary: The aim of this study is to determine responses of the immune system to the annual flu vaccination in people with COPD who experience frequent or infrequent exacerbations and healthy participants. We will collect blood and saliva immediately before and one month after flu vaccination at GP surgeries in the Autumn/Winter period. By measuring how quickly antibodies (that provide protection against infection) develop in the blood after vaccination we can provide important new information to help confirm whether those prone to COPD flare ups have weaker immune systems.


Eligibility criteria: Inclusion Criteria:

Patients aged 65-85 years with a diagnosis of COPD (according to Global Initiative for Chronic Obstructive Lung Disease criteria: post bronchodilator FEV1/FVC ratio \<0.70) and moderate to severe airflow limitation (FEV1 30-80% predicted) who opt to receive the annual influenza vaccine.

We will also include healthy participants aged 65-85 years without symptoms of lung disease who opt to receive the annual influenza vaccine.

Exclusion Criteria:

* Unable/unwilling to provide informed consent
* Any history of allergies, suspected hypersensitivity and/or contraindication to vaccines (e.g egg protein allergy)
* Participation in another clinical trial (use of investigational product or device)
* Not on optimal treatment (COPD patients only)
* Current smokers, exhaled CO \>10 parts per million
* Clinical instability, defined as experiencing a COPD exacerbation less than 4 weeks prior to baseline visit, as indicated by treatment with systemic glucocorticosteroids and/or antibiotics and/or hospitalization (COPD only)
* An upper/lower respiratory tract infection e.g. common cold, sinus symptoms, pneumonia, which has not resolved four weeks prior to baseline visit
* Diagnosis of asthma and/or other relevant lung disease (e.g. history of primary or clinically significant bronchiectases, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease \[e.g. fibrosis, silicosis, sarcoidosis\], active tuberculosis)
* Known alpha-1-antitrypsin deficiency
* Immunological diseases or known infection with Human Immunodeficiency Virus (HIV)
* Any diagnosis of a malignant disease (other than basal or squamous cell carcinoma) in the last 5 years
* Currently taking immunosuppressive medications
* Diagnosis of diabetes mellitus
* Severe renal failure (calculated eGFR less than 60 ml/min)
* Liver impairment Child-Pugh B/C and/or active viral hepatitis
* Severe psychiatric or neurological disorders (Parkinson's disease or motor neurone disease)
* Planned donation of human tissue (blood, organs or bone marrow) during the course of the trial

Primary outcomes:
measure: Haemagglutination inhibition (HI) antibody titres
timeFrame: October 2016 - August 2017
Secondary outcomes:
measure: Pseudotype-based neutralization antibody titres
timeFrame: October 2016 - August 2017
measure: Serum and saliva concentrations of total (and sub-classes of) IgA, IgG and IgM
timeFrame: October 2016 - August 2017
measure: Concentrations of inflammatory mediators in RNA extracted from unstimulated and in vitro stimulated peripheral blood mononuclear cells.
timeFrame: October 2016 - August 2017
measure: Plasma concentrations of markers of B and T cell activation
timeFrame: October 2016 - August 2017
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: Lincolnshire West CCG
city: Lincoln
country: United Kingdom
facility: South Lincolnshire CCG
Study officials:
affiliation: University of Kent
name: Glen Davison, PhD
role: PRINCIPAL_INVESTIGATOR
References: