<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03804138</url>
  </required_header>
  <id_info>
    <org_study_id>ALTIBPCO</org_study_id>
    <secondary_id>2018-A01719-46</secondary_id>
    <nct_id>NCT03804138</nct_id>
  </id_info>
  <brief_title>Immune Damage and Vaccination in COPD Patients</brief_title>
  <acronym>ALTIBPCO</acronym>
  <official_title>Immune Damage and Vaccination in COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Better understanding of the specificities of the vaccine response in patients with COPD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death&#xD;
      worldwide in 2020 (3.5 million patients, 16500 deaths in France). Its socio-economic cost is&#xD;
      related to the handicap induced by the decline of the respiratory function, as well as to the&#xD;
      occurrence of exacerbations, main causes of hospitalization and mortality. Since&#xD;
      exacerbations are mostly infectious, a preventive strategy involves routine influenza&#xD;
      vaccination. Although it is highly recommended in this population, there is no formal&#xD;
      evidence of its effectiveness during COPD. While correlates of influenza vaccine efficacy&#xD;
      exist, cellular and humoral responses to this vaccine have been poorly evaluated in these&#xD;
      patients. This alteration of the vaccine response could also be integrated into an overall&#xD;
      deficit of the response to a vaccine in these patients.&#xD;
&#xD;
      As influenza virus infection is one of the most important causes of death in patients with&#xD;
      COPD, and vaccination is the best way to prevent it, it is essential to better understand the&#xD;
      immune response in the context of vaccination in this population. The investigator's&#xD;
      hypothesis is that there would be a global alteration of the immunological immune response in&#xD;
      the COPD patient involving abnormalities of lymphocyte B differentiation and the effector&#xD;
      capacity of T lymphocytes, notably through the activation of the PD1 / PDL1 axis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2018</start_date>
  <completion_date type="Actual">February 3, 2023</completion_date>
  <primary_completion_date type="Actual">February 3, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate and evolution of specific antibodies and Cellular B vaccine response</measure>
    <time_frame>30 days</time_frame>
    <description>Rate and evolution of J30-specific antibodies according to WHO criteria Tetanus: before vaccination a rate&gt; 0.1 IU / ml is considered protective, that is usually at a rate&gt; 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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of Cellular T cell response</measure>
    <time_frame>15 days</time_frame>
    <description>Cellular T cell response (Tfh, Treg, TCD4 / TCD8 specific)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcriptomic analysis</measure>
    <time_frame>30 days</time_frame>
    <description>Transcriptomic analysis in the pre- and post-vaccination period (vaccine signature) and comparison with matched subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Lymphocyte populations</measure>
    <time_frame>7 days</time_frame>
    <description>Analysis of lymphocyte populations B and T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of exacerbations</measure>
    <time_frame>6 months</time_frame>
    <description>Number of minimal, moderate and severe exacerbations within 6 months of vaccination</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <description>patient with COPD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>patient without COPD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anti-influenza and DTp pertussis vaccinations</intervention_name>
    <description>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).</description>
    <arm_group_label>Patient</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be offered to patients for whom there is a prescription for influenza&#xD;
        vaccination and DTp, COPD or non-COPD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acceptance to participate in the protocol&#xD;
&#xD;
          -  Affiliated to a social security scheme&#xD;
&#xD;
          -  Age between 40 and 65 years COPD patients&#xD;
&#xD;
          -  Diagnosis of moderate to very severe COPD with FEV1 / FVC &lt;0.7 and FEV1 &lt;80% of&#xD;
             predicted value, cumulative smoking greater than 10PA&#xD;
&#xD;
          -  Indication reminder dTP pertussis when the last booster &lt;5 years Patients without COPD&#xD;
&#xD;
          -  FEV / FVC&gt; 0.8&#xD;
&#xD;
          -  Indication reminder dTP pertussis when the last booster &lt;5 years&#xD;
&#xD;
          -  Indication and patient's wish for an influenza vaccination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Progressive cancer and / or treated in the last 5 years, uncontrolled heart failure,&#xD;
             connective tissue disease, inflammatory disease of the digestive tract during&#xD;
             treatment.&#xD;
&#xD;
          -  Exacerbation or any upper or lower respiratory infection in the previous month.&#xD;
&#xD;
          -  Any cause of immunodepression, including long-term oral corticosteroids.&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurent Boyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Henri-Mondor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHI Créteil</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri-Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804138
org study id: ALTIBPCO
secondary id: 2018-A01719-46
nct id: NCT03804138
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Better understanding of the specificities of the vaccine response in patients with COPD
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.
observational model: Case-Control
time perspective: Prospective
measure: Rate and evolution of specific antibodies and Cellular B vaccine response
time frame: 30 days
description: 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)
measure: Type of Cellular T cell response
time frame: 15 days
description: Cellular T cell response (Tfh, Treg, TCD4 / TCD8 specific)
measure: Transcriptomic analysis
time frame: 30 days
description: Transcriptomic analysis in the pre- and post-vaccination period (vaccine signature) and comparison with matched subjects
measure: Number of Lymphocyte populations
time frame: 7 days
description: Analysis of lymphocyte populations B and T
measure: Number of exacerbations
time frame: 6 months
description: Number of minimal, moderate and severe exacerbations within 6 months of vaccination
arm group label: Patient
description: patient with COPD
arm group label: control group
description: patient without COPD
intervention type: Other
intervention name: Anti-influenza and DTp pertussis vaccinations
description: 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).
arm group label: Patient
arm group label: control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: Laurent Boyer, MD
role: Principal Investigator
affiliation: CHU Henri-Mondor
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive