NCT Number: NCT02900209
Influenza Vaccination and COPD Phenotypes
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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Notify MeKey information
Conditions
Age range
65 year–85 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Lincolnshire West CCG, Lincoln, United Kingdom
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Haemagglutination inhibition (HI) antibody titres
Time frame: October 2016 - August 2017
Secondary outcomes
-
Pseudotype-based neutralization antibody titres
Time frame: October 2016 - August 2017
-
Serum and saliva concentrations of total (and sub-classes of) IgA, IgG and IgM
Time frame: October 2016 - August 2017
-
Concentrations of inflammatory mediators in RNA extracted from unstimulated and in vitro stimulated peripheral blood mononuclear cells.
Time frame: October 2016 - August 2017
-
Plasma concentrations of markers of B and T cell activation
Time frame: October 2016 - August 2017
Sponsors and collaborators
Lead sponsor
University of Lincoln
Other
Collaborators
- NHS Lincolnshire West Clinical Commissioning Group
- NHS South Lincolnshire Clinical Commissioning Group
- University of Kent
Registry information
Official study title
Responses of the Immune System to Influenza Vaccination in Phenotypes of Chronic Obstructive Pulmonary Disease
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 14, 2016
- Registry last updated
- Oct 26, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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