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OpenTrials
Completed

NCT Number: NCT03804138

Immune Damage and Vaccination in COPD Patients

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Créteil, Créteil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Rate and evolution of specific antibodies and Cellular B vaccine response

    Time frame: 30 days

    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)

Secondary outcomes

  1. Type of Cellular T cell response

    Time frame: 15 days

    Cellular T cell response (Tfh, Treg, TCD4 / TCD8 specific)

  2. Transcriptomic analysis

    Time frame: 30 days

    Transcriptomic analysis in the pre- and post-vaccination period (vaccine signature) and comparison with matched subjects

  3. Number of Lymphocyte populations

    Time frame: 7 days

    Analysis of lymphocyte populations B and T

  4. Number of exacerbations

    Time frame: 6 months

    Number of minimal, moderate and severe exacerbations within 6 months of vaccination

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: ALTIBPCO

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Jan 15, 2019
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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