Influenza Vaccination and COPD Phenotypes

NCT02900209 | Completed

• 1 other identifier: CoSREC192
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Influenza; Exacerbations

Outcome Measures

Primary Outcomes (1)

• Haemagglutination inhibition (HI) antibody titres

  October 2016 - August 2017

Secondary Outcomes (4)

• 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

Study Arms (3)

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

Interventions

Influenza Vaccination OTHER

COPD frequent exacerbators; COPD infrequent exacerbators; Healthy controls

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lincoln: lead
• University of Kent: collaborator
• NHS Lincolnshire West Clinical Commissioning Group: collaborator
• NHS South Lincolnshire Clinical Commissioning Group: collaborator

Study Sites (2)

Lincolnshire West CCG

Lincoln, United Kingdom

Location

South Lincolnshire CCG

Lincoln, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected in K3EDTA and serum vacutainer tubes. Saliva samples will be obtained while participant is seated with the head tilted slightly forward and passively dribbling into a pre-weighed sterile tube (keeping orofacial movement to a minimum). Whole blood samples will be used on the day of collection and analysed before being appropriately disposed of on the same day. Blood samples will be centrifuged with plasma and serum frozen at -80c for later analysis. Saliva samples will also be centrifuged with supernatant frozen at -80c for later analysis.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Glen Davison, PhD

  University of Kent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)