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

University of Lincoln2 sites in 1 country54 target enrollmentOctober 2016

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: University of Lincoln
Enrollment: 54
Locations: 2
Primary Endpoint: Haemagglutination inhibition (HI) antibody titres
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

September 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Lincoln

Responsible Party

Principal Investigator

Arwel Jones

Research Fellow

University of Lincoln

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)

Outcomes

Primary Outcomes

Haemagglutination inhibition (HI) antibody titres

Time Frame: October 2016 - August 2017

Secondary Outcomes

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)