Immune Damage and Vaccination in COPD Patients

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Anti-influenza and DTp pertussis vaccinations

• Registration Number: NCT03804138
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study Start: 2018-10-09
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Primary Completion: 2021-02-03
• Study Completion: 2023-02-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Anti-influenza and DTp pertussis vaccinations	patient without COPD
Patient	Anti-influenza and DTp pertussis vaccinations	patient with COPD

Primary Outcome Measures

Name	Time	Method
Rate and evolution of specific antibodies and Cellular B vaccine response	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)

Secondary Outcome Measures

Name	Time	Method
Number of exacerbations	6 months	Number of minimal, moderate and severe exacerbations within 6 months of vaccination
Transcriptomic analysis	30 days	Transcriptomic analysis in the pre- and post-vaccination period (vaccine signature) and comparison with matched subjects
Type of Cellular T cell response	15 days	Cellular T cell response (Tfh, Treg, TCD4 / TCD8 specific)
Number of Lymphocyte populations	7 days	Analysis of lymphocyte populations B and T

Trial Locations

Locations (2)

CHI Créteil; 🇫🇷 Créteil, France

CHU Henri-Mondor; 🇫🇷 Créteil, France