Immune Damage and Vaccination in COPD Patients

NCT03804138 | Completed

• 2 other identifiers: ALTIBPCO2018-A01719-46
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Type of Cellular T cell response

  15 days

• Transcriptomic analysis

  30 days

• Number of Lymphocyte populations

  7 days

• Number of exacerbations

  6 months

Study Arms (2)

Patient

patient with COPD

Other: Anti-influenza and DTp pertussis vaccinations

control group

patient without COPD

Other: Anti-influenza and DTp pertussis vaccinations

Interventions

Anti-influenza and DTp pertussis vaccinations 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).

Patient; control group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (2)

CHI Créteil

Créteil, 94000, France

Location

CHU Henri-Mondor

Créteil, 94000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Boyer, MD

  CHU Henri-Mondor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: October 9, 2018
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

FR (2)