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| Name | Class |
|---|---|
| University of Kent | OTHER |
| NHS Lincolnshire West Clinical Commissioning Group | OTHER |
| NHS South Lincolnshire Clinical Commissioning Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Healthy controls | Aged 65-85 years and do not have any symptoms of lung disease and have normal spirometry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccination | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemagglutination inhibition (HI) antibody titres | October 2016 - August 2017 |
| Measure | Description | 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 | |
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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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Glen Davison, PhD | University of Kent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincolnshire West CCG | Lincoln | United Kingdom | ||||
| South Lincolnshire CCG |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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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.
| 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 |
| Lincoln |
| United Kingdom |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |