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Trial record 21 of 1709 for:    influenza vaccination

Influenza Vaccination and COPD Phenotypes

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ClinicalTrials.gov Identifier: NCT02900209
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
University of Kent
NHS Lincolnshire West Clinical Commissioning Group
NHS South Lincolnshire Clinical Commissioning Group
Information provided by (Responsible Party):
Arwel Jones, University of Lincoln

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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: Influenza Vaccination

Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Responses of the Immune System to Influenza Vaccination in Phenotypes of Chronic Obstructive Pulmonary Disease
Study Start Date : October 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Haemagglutination inhibition (HI) antibody titres [ Time Frame: October 2016 - August 2017 ]

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

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.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900209


Locations
United Kingdom
Lincolnshire West CCG
Lincoln, United Kingdom
South Lincolnshire CCG
Lincoln, United Kingdom
Sponsors and Collaborators
University of Lincoln
University of Kent
NHS Lincolnshire West Clinical Commissioning Group
NHS South Lincolnshire Clinical Commissioning Group
Investigators
Principal Investigator: Glen Davison, PhD University of Kent

Responsible Party: Arwel Jones, Research Fellow, University of Lincoln
ClinicalTrials.gov Identifier: NCT02900209     History of Changes
Other Study ID Numbers: CoSREC192
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arwel Jones, University of Lincoln:
Influenza
Exacerbations

Additional relevant MeSH terms:
Influenza, Human
Vaccines
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Immunologic Factors
Physiological Effects of Drugs