Immune Damage and Vaccination in COPD Patients

NCT ID: NCT03804138

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-09
• Study Completion Date: 2023-02-03

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient

patient with COPD

Anti-influenza and DTp pertussis vaccinations

Intervention Type: OTHER

Anti-influenza and DTp pertussis vaccinations will be performed during the visit by the clinical research nurse. The vaccine has been prescribed as part of the care either by the patient's physician (pulmonologist or general practitioner).

control group

patient without COPD

Anti-influenza and DTp pertussis vaccinations

Intervention Type: OTHER

Anti-influenza and DTp pertussis vaccinations will be performed during the visit by the clinical research nurse. The vaccine has been prescribed as part of the care either by the patient's physician (pulmonologist or general practitioner).

Interventions

Anti-influenza and DTp pertussis vaccinations

Anti-influenza and DTp pertussis vaccinations will be performed during the visit by the clinical research nurse. The vaccine has been prescribed as part of the care either by the patient's physician (pulmonologist or general practitioner).

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Boyer, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Henri-Mondor

Locations

CHI Créteil

Créteil, , France

CHU Henri-Mondor

Créteil, , France

Countries

France

Other Identifiers

2018-A01719-46

Identifier Type: OTHER

Identifier Source: secondary_id

ALTIBPCO

Identifier Type: -

Identifier Source: org_study_id