Clinical trial NCT03804138: Immune Damage and Vaccination in COPD Patients
Official title: Immune Damage and Vaccination in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be offered to patients for whom there is a prescription for influenza vaccination and DTp, COPD or non-COPD

Brief summary: Better understanding of the specificities of the vaccine response in patients with COPD

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate and evolution of specific antibodies and Cellular B vaccine response
timeFrame: 30 days
Secondary outcomes:
measure: Type of Cellular T cell response
timeFrame: 15 days
measure: Transcriptomic analysis
timeFrame: 30 days
measure: Number of Lymphocyte populations
timeFrame: 7 days
measure: Number of exacerbations
timeFrame: 6 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Créteil
city: Créteil
country: France
facility: CHU Henri-Mondor
Study officials:
affiliation: CHU Henri-Mondor
name: Laurent Boyer, MD
role: PRINCIPAL_INVESTIGATOR
References: