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Immune Damage and Vaccination in COPD Patients

Immune Damage and Vaccination in COPD Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03804138
Acronym
ALTIBPCO
Enrollment
37
Registered
2019-01-15
Start date
2018-10-09
Completion date
2023-02-03
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

OTHERAnti-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).

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate and evolution of specific antibodies and Cellular B vaccine response30 daysRate 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

MeasureTime frameDescription
Type of Cellular T cell response15 daysCellular T cell response (Tfh, Treg, TCD4 / TCD8 specific)
Transcriptomic analysis30 daysTranscriptomic analysis in the pre- and post-vaccination period (vaccine signature) and comparison with matched subjects
Number of Lymphocyte populations7 daysAnalysis of lymphocyte populations B and T
Number of exacerbations6 monthsNumber of minimal, moderate and severe exacerbations within 6 months of vaccination

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026