<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/NCT02255227</url>
  </required_header>
  <id_info>
    <org_study_id>1308162</org_study_id>
    <secondary_id>2013-004609-19</secondary_id>
    <nct_id>NCT02255227</nct_id>
  </id_info>
  <brief_title>Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD</brief_title>
  <acronym>PneumoMICI</acronym>
  <official_title>Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal&#xD;
      vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by&#xD;
      immunosuppressants and/or biotherapies. At present such patients are poorly protected by&#xD;
      anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is&#xD;
      much weaker than in the general population. There are two types of anti-pneumococcal&#xD;
      vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate,&#xD;
      Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising&#xD;
      immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13®&#xD;
      followed by one dose of PSV-23® after an interval of two months. In the case of young&#xD;
      children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the&#xD;
      PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.&#xD;
&#xD;
      Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD&#xD;
      patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine,&#xD;
      PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with&#xD;
      a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer&#xD;
      against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We&#xD;
      also want to evaluate the immunological impact of these different strategies in their&#xD;
      capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim,&#xD;
      we are studying all immunological functional aspects of the antibodies and B lymphocytes&#xD;
      induced by the two vaccine strategies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    low inclusion rates&#xD;
  </why_stopped>
  <start_date type="Actual">April 13, 2015</start_date>
  <completion_date type="Actual">July 6, 2022</completion_date>
  <primary_completion_date type="Actual">August 6, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of patients with anti-pneumococcal immunogenicity</measure>
    <time_frame>month 5</time_frame>
    <description>Measured the serologies against serotypes to Prevenar 13. Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the ELISA method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with local and/or general reaction</measure>
    <time_frame>Months 1, 3 and 5</time_frame>
    <description>self monitoring diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with inflammatory disease activity</measure>
    <time_frame>Months 1, 3, 4, 5, 12, 18, 36</time_frame>
    <description>by clinic score HBI or CDAI or Mayo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors implicated in anti-pneumococcal vaccination efficacy</measure>
    <time_frame>Month 0</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with serotype coverage of PSV-23</measure>
    <time_frame>Months 5, 12, 18 and 36</time_frame>
    <description>Measured the serologies against serotypes to Pneumo 23. Serotype to be measured are serotypes 10 and 15 using the ELISA method</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Infections, Pneumococcal</condition>
  <condition>Bowel Diseases, Inflammatory</condition>
  <arm_group>
    <arm_group_label>1 dose Prevenar13 and 1 dose PSV23</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one dose of the polysaccharide vaccine, Prevenar 13 at M0 and one dose of polysaccharide vaccine, Pneumo 23 at M4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 doses Prevenar13 and 1 dose PSV23</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one dose of the polysaccharide vaccine, Prevenar 13 at M0, one dose of the polysaccharide vaccine, Prevenar 13, at M2 and one dose of polysaccharide vaccine, Pneumo 23 at M4</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevenar 13</intervention_name>
    <description>one dose for arm 1 and 2 doses for arm 2</description>
    <arm_group_label>1 dose Prevenar13 and 1 dose PSV23</arm_group_label>
    <arm_group_label>2 doses Prevenar13 and 1 dose PSV23</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pneumo 23</intervention_name>
    <description>one dose</description>
    <arm_group_label>1 dose Prevenar13 and 1 dose PSV23</arm_group_label>
    <arm_group_label>2 doses Prevenar13 and 1 dose PSV23</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who have given their written consent in a free and informed consent&#xD;
&#xD;
          -  Patient followed for inflammatory bowel disease (Crohn's disease, ulcerative colitis&#xD;
             or indeterminate colitis), and treated for at least 3 months by immunosuppressive&#xD;
             therapy and /or biotherapies and in clinical remission for at least 3 months&#xD;
&#xD;
          -  Patient agreeing to participate in the study throughout its duration and accepting the&#xD;
             procedures related to the study&#xD;
&#xD;
          -  Contraception that the investigator judges effective for the first 12 months of the&#xD;
             trial, with a negative pregnancy test&#xD;
&#xD;
          -  Women not planning to become pregnant in the 12 months following inclusion (M0)&#xD;
&#xD;
          -  Patient with social coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients vaccinated against pneumo23 for less than 5 years&#xD;
&#xD;
          -  Other vaccination during the month before inclusion&#xD;
&#xD;
          -  Patient develops a febrile illness (at least 37 ° C 5 measured orally) or acute&#xD;
             infection in the week before vaccination&#xD;
&#xD;
          -  The patient has a flare up of IBD the day of vaccination (Harvey-Brasdshaw score of at&#xD;
             least 6 or CDAI &gt; 220 for Crohn's disease or Mayo Clinic score of at least 4 for UC&#xD;
             and indeterminate colitis)&#xD;
&#xD;
          -  Patients with an ongoing pregnancy the day of vaccination&#xD;
&#xD;
          -  Patient with a known history of neuropathy as Guillain-Barré syndrome.&#xD;
&#xD;
          -  Patients with known infection with HIV and / or HBV (HBsAg positive) and / or HCV&#xD;
&#xD;
          -  Patient with other severe immune deficiency&#xD;
&#xD;
          -  Patients who received immunoglobulin infusions of blood products, or of monoclonal&#xD;
             antibodies (except anti-TNF) in the 3 months prior to vaccination&#xD;
&#xD;
          -  Patient institutionalized, or deprived of liberty administrative or judicial&#xD;
&#xD;
          -  Patients treated without immunosuppressive therapy or biotherapies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Roblin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Amiens-Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de l'Archet II</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaccination</keyword>
  <keyword>randomized</keyword>
  <keyword>anti-pneumococcal</keyword>
  <keyword>Pneumo 23</keyword>
  <keyword>Prevenar 13</keyword>
  <keyword>Chronic Inflammatory Bowel Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumococcal Infections</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_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/NCT02255227
org study id: 1308162
secondary id: 2013-004609-19
nct id: NCT02255227
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal
      vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by
      immunosuppressants and/or biotherapies. At present such patients are poorly protected by
      anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is
      much weaker than in the general population. There are two types of anti-pneumococcal
      vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate,
      Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising
      immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13®
      followed by one dose of PSV-23® after an interval of two months. In the case of young
      children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the
      PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.

      Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD
      patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine,
      PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with
      a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer
      against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We
      also want to evaluate the immunological impact of these different strategies in their
      capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim,
      we are studying all immunological functional aspects of the antibodies and B lymphocytes
      induced by the two vaccine strategies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: number of patients with anti-pneumococcal immunogenicity
time frame: month 5
description: Measured the serologies against serotypes to Prevenar 13. Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the ELISA method
measure: Number of patients with local and/or general reaction
time frame: Months 1, 3 and 5
description: self monitoring diary
measure: Number of patients with inflammatory disease activity
time frame: Months 1, 3, 4, 5, 12, 18, 36
description: by clinic score HBI or CDAI or Mayo
measure: Factors implicated in anti-pneumococcal vaccination efficacy
time frame: Month 0
description: questionnaire
measure: number of patients with serotype coverage of PSV-23
time frame: Months 5, 12, 18 and 36
description: Measured the serologies against serotypes to Pneumo 23. Serotype to be measured are serotypes 10 and 15 using the ELISA method
arm group label: 1 dose Prevenar13 and 1 dose PSV23
arm group type: Active Comparator
description: one dose of the polysaccharide vaccine, Prevenar 13 at M0 and one dose of polysaccharide vaccine, Pneumo 23 at M4
arm group label: 2 doses Prevenar13 and 1 dose PSV23
arm group type: Experimental
description: one dose of the polysaccharide vaccine, Prevenar 13 at M0, one dose of the polysaccharide vaccine, Prevenar 13, at M2 and one dose of polysaccharide vaccine, Pneumo 23 at M4
intervention type: Biological
intervention name: Prevenar 13
description: one dose for arm 1 and 2 doses for arm 2
arm group label: 1 dose Prevenar13 and 1 dose PSV23
arm group label: 2 doses Prevenar13 and 1 dose PSV23
intervention type: Biological
intervention name: Pneumo 23
description: one dose
arm group label: 1 dose Prevenar13 and 1 dose PSV23
arm group label: 2 doses Prevenar13 and 1 dose PSV23
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier Roblin, MD
role: Principal Investigator
affiliation: CHU Saint-Etienne
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Heptavalent Pneumococcal Conjugate Vaccine