Immune Damage and Vaccination in COPD Patients (ALTIBPCO)

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Anti-influenza and DTp pertussis vaccinations

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • CHI Créteil
  • Créteil, France, 94000
    • CHU Henri-Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; patient with COPD	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).
control group; patient without COPD	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): February 3, 2021
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ALTIBPCO; 2018-A01719-46 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No