NCT02900209已完成不适用
Responses of the Immune System to Influenza Vaccination in Phenotypes of Chronic Obstructive Pulmonary Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Haemagglutination inhibition (HI) antibody titres
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Haemagglutination inhibition (HI) antibody titres
时间窗: October 2016 - August 2017
次要结局
- 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)
研究者
Arwel Jones
Research Fellow
University of Lincoln
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Immune Response to Influenza VaccinationSolid Organ TransplantationChronic Kidney DiseaseNCT00551837The Cleveland Clinic82
已完成
4 期
Immunologic Response to FluMist vs. FlucelvaxInfluenza, HumanImmune ResponseNCT03982069Richard Zimmerman MD465
终止
不适用
Immune Response to Influenza Vaccine in Adults With B-cell Malignancies Treated With IdelalisibB-cell MalignanciesNCT03701438Gilead Sciences2
已完成
4 期
Immunologic Response to Influenza Vaccination in Children and AdolescentsInfluenza, HumanImmune ResponseNCT03614975Richard Zimmerman MD166
已完成
4 期
Study of Immune Responses to Influenza VaccinationInfluenza VaccinationNCT03346772University of Pennsylvania150