Immune Damage and Vaccination in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Rate and evolution of specific antibodies and Cellular B vaccine response
研究概览
简要总结
Better understanding of the specificities of the vaccine response in patients with COPD
详细描述
Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death worldwide in 2020 (3.5 million patients, 16500 deaths in France). Its socio-economic cost is related to the handicap induced by the decline of the respiratory function, as well as to the occurrence of exacerbations, main causes of hospitalization and mortality. Since exacerbations are mostly infectious, a preventive strategy involves routine influenza vaccination. Although it is highly recommended in this population, there is no formal evidence of its effectiveness during COPD. While correlates of influenza vaccine efficacy exist, cellular and humoral responses to this vaccine have been poorly evaluated in these patients. This alteration of the vaccine response could also be integrated into an overall deficit of the response to a vaccine in these patients.
As influenza virus infection is one of the most important causes of death in patients with COPD, and vaccination is the best way to prevent it, it is essential to better understand the immune response in the context of vaccination in this population. The investigator's hypothesis is that there would be a global alteration of the immunological immune response in the COPD patient involving abnormalities of lymphocyte B differentiation and the effector capacity of T lymphocytes, notably through the activation of the PD1 / PDL1 axis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acceptance to participate in the protocol
- •Affiliated to a social security scheme
- •Age between 40 and 65 years COPD patients
- •Diagnosis of moderate to very severe COPD with FEV1 / FVC <0.7 and FEV1 <80% of predicted value, cumulative smoking greater than 10PA
- •Indication reminder dTP pertussis when the last booster <5 years Patients without COPD
- •FEV / FVC> 0.8
- •Indication reminder dTP pertussis when the last booster <5 years
- •Indication and patient's wish for an influenza vaccination
排除标准
- •Refusal to participate in the study
- •Progressive cancer and / or treated in the last 5 years, uncontrolled heart failure, connective tissue disease, inflammatory disease of the digestive tract during treatment.
- •Exacerbation or any upper or lower respiratory infection in the previous month.
- •Any cause of immunodepression, including long-term oral corticosteroids.
- •Pregnant or lactating woman
结局指标
主要结局
Rate and evolution of specific antibodies and Cellular B vaccine response
时间窗: 30 days
Rate and evolution of J30-specific antibodies according to WHO criteria Tetanus: before vaccination a rate\> 0.1 IU / ml is considered protective, that is usually at a rate\> 1 IU / ml after booster vaccination Influenza: antibody concentrations exceeding 0.15 μg / ml are considered protective Pertussis: anti-pertussis toxin IgG (PT) Cellular B vaccine response (plasmablast on D7)
次要结局
- Number of exacerbations(6 months)
- Transcriptomic analysis(30 days)
- Type of Cellular T cell response(15 days)
- Number of Lymphocyte populations(7 days)