Immune Damage and Vaccination in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— ALTIBPCO  

Official title:

Immune Damage and Vaccination in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804138
• Other study ID #: ALTIBPCO
• Secondary ID: 2018-A01719-46
• Status: Completed
• Start date: October 9, 2018
• Est. completion date: February 3, 2023

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Better understanding of the specificities of the vaccine response in patients with COPD

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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).

Locations

Country	Name	City	State
France	CHI Créteil	Créteil
France	CHU Henri-Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

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