Influenza Vaccination and COPD Phenotypes

Responses of the Immune System to Influenza Vaccination in Phenotypes of Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Influenza Vaccination

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United Kingdom
  • Lincoln, United Kingdom
    • Lincolnshire West CCG
  • Lincoln, United Kingdom
    • South Lincolnshire CCG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD frequent exacerbators; 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). Moderate to severe airflow limitation (FEV1 30-80% predicted). Patients have experienced 2 or more exacerbations requiring oral steroids/antibiotics treatment and/or hospitalisation in the previous 12 months.	Other: Influenza Vaccination
COPD infrequent exacerbators; 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). Moderate to severe airflow limitation (FEV1 30-80% predicted). Patients have experienced no more than 1 course of oral steroids/antibiotics and none exacerbations requiring hospital admission in the previous 12 months.	Other: Influenza Vaccination
Healthy controls; Aged 65-85 years and do not have any symptoms of lung disease and have normal spirometry.	Other: Influenza Vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Haemagglutination inhibition (HI) antibody titres	October 2016 - August 2017

Secondary Outcome Measures

Outcome Measure	Time Frame
Pseudotype-based neutralization antibody titres	October 2016 - August 2017
Serum and saliva concentrations of total (and sub-classes of) IgA, IgG and IgM	October 2016 - August 2017
Concentrations of inflammatory mediators in RNA extracted from unstimulated and in vitro stimulated peripheral blood mononuclear cells.	October 2016 - August 2017
Plasma concentrations of markers of B and T cell activation	October 2016 - August 2017

Collaborators and Investigators

• Sponsor: University of Lincoln
• Collaborators: University of Kent; NHS Lincolnshire West Clinical Commissioning Group; NHS South Lincolnshire Clinical Commissioning Group
• Investigators: Principal Investigator: Glen Davison, PhD, University of Kent

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Influenza; Exacerbations
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases, Obstructive; Orthomyxoviridae Infections; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Influenza, Human
• Other Study ID Numbers: CoSREC192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No