<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/NCT02240888</url>
  </required_header>
  <id_info>
    <org_study_id>2011/341</org_study_id>
    <secondary_id>Vaccimil</secondary_id>
    <nct_id>NCT02240888</nct_id>
  </id_info>
  <brief_title>Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response</brief_title>
  <acronym>Vaccimil</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this project is to study the influence of modern anti-inflammatory&#xD;
      treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited&#xD;
      by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In&#xD;
      addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in&#xD;
      immunosuppressed patients with IRD, impact on existing rheumatic disease, possible&#xD;
      association with onset of new autoimmune diseases, long-term immunity following pneumococcal&#xD;
      vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related&#xD;
      serious infections. Results from this study are expected to bridge the existing knowledge gap&#xD;
      and contribute to body of evidence needed for recommendations and implementation of&#xD;
      vaccination program in IRD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>antibody response following vaccination</measure>
    <time_frame>4-6 weeks after pneumococcal and influenza vaccination</time_frame>
    <description>measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>long-term immunity following pneumococcal vaccination</measure>
    <time_frame>3 years after pneumococcal vaccination</time_frame>
    <description>measurement of antibody levels against different pneumococcal capsular serotypes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>long-term immunity after vaccination with pneumococcal conjugate vaccine</measure>
    <time_frame>5 years after vaccination</time_frame>
    <description>measurement of antibody levels against different pneumococcal polysaccharide serotypes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The occurence of severe pneumococcal infections in immunized patients</measure>
    <time_frame>within 5 years after pneumococcal vaccination</time_frame>
    <description>Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>RA</condition>
  <condition>SLE</condition>
  <condition>Vasculitis</condition>
  <condition>Scleroderma</condition>
  <condition>Sjögrens</condition>
  <condition>Syndrome</condition>
  <arm_group>
    <arm_group_label>vaccinated patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vaccinated controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>seasonal influenza vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-vaccinated controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>0,5 mg Prevenar i.m.</intervention_name>
    <arm_group_label>non-vaccinated controls</arm_group_label>
    <arm_group_label>seasonal influenza vaccine</arm_group_label>
    <arm_group_label>vaccinated controls</arm_group_label>
    <arm_group_label>vaccinated patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>0,5 mg seasonal influenza vaccine i.m.</intervention_name>
    <arm_group_label>non-vaccinated controls</arm_group_label>
    <arm_group_label>seasonal influenza vaccine</arm_group_label>
    <arm_group_label>vaccinated controls</arm_group_label>
    <arm_group_label>vaccinated patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or&#xD;
             biological remedies are offered to participate in the study. The protocol permits&#xD;
             stratification for prednisolone usage, smoking habits and alcohol consumption.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years;&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  known intolerance of vaccine,&#xD;
&#xD;
          -  ongoing infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meliha C Kapetanovic, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Skåne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jehns Martineus, MD</last_name>
    <role>Study Director</role>
    <affiliation>Skåne Universitets sjukhus, dept of rheumatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skåne University hospital, Dept of rheumatology</name>
      <address>
        <city>Lund</city>
        <zip>SE-22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>meliha crnkic kapetanovic</investigator_full_name>
    <investigator_title>MD, PhD, associate professor</investigator_title>
  </responsible_party>
  <keyword>pneumococcal</keyword>
  <keyword>vaccination</keyword>
  <keyword>antibody</keyword>
  <keyword>response</keyword>
  <keyword>immunosuppressive</keyword>
  <keyword>treatment</keyword>
  <keyword>inflammatory</keyword>
  <keyword>rheumatic</keyword>
  <keyword>disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasculitis</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>
  <pending_results>
    <submitted>December 11, 2018</submitted>
    <returned>March 21, 2019</returned>
  </pending_results>
  <!-- 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/NCT02240888
org study id: 2011/341
secondary id: Vaccimil
nct id: NCT02240888
lead sponsor: 
has dmc: No
The overall objective of this project is to study the influence of modern anti-inflammatory
      treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited
      by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In
      addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in
      immunosuppressed patients with IRD, impact on existing rheumatic disease, possible
      association with onset of new autoimmune diseases, long-term immunity following pneumococcal
      vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related
      serious infections. Results from this study are expected to bridge the existing knowledge gap
      and contribute to body of evidence needed for recommendations and implementation of
      vaccination program in IRD patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: antibody response following vaccination
time frame: 4-6 weeks after pneumococcal and influenza vaccination
description: measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains
measure: long-term immunity following pneumococcal vaccination
time frame: 3 years after pneumococcal vaccination
description: measurement of antibody levels against different pneumococcal capsular serotypes
measure: long-term immunity after vaccination with pneumococcal conjugate vaccine
time frame: 5 years after vaccination
description: measurement of antibody levels against different pneumococcal polysaccharide serotypes
measure: The occurence of severe pneumococcal infections in immunized patients
time frame: within 5 years after pneumococcal vaccination
description: Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls
arm group label: vaccinated patients
arm group type: Active Comparator
description: patients with different inflammatory rheumatic disease immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
arm group label: vaccinated controls
arm group type: Active Comparator
description: healthy controls immunized with 0,5 mg pneumococcal conjugate vaccine i.m.
arm group label: seasonal influenza vaccine
arm group type: Active Comparator
description: patients with different inflammatory rheumatic diseases immunized with 0,5 mg seasonal influenza vaccine i.m.
arm group label: non-vaccinated controls
arm group type: Active Comparator
description: healthy controls immunized with 0,5 mg seasonal influenza vaccine i.m.
intervention type: Biological
intervention name: 0,5 mg Prevenar i.m.
arm group label: non-vaccinated controls
arm group label: seasonal influenza vaccine
arm group label: vaccinated controls
arm group label: vaccinated patients
intervention type: Biological
intervention name: 0,5 mg seasonal influenza vaccine i.m.
arm group label: non-vaccinated controls
arm group label: seasonal influenza vaccine
arm group label: vaccinated controls
arm group label: vaccinated patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Meliha C Kapetanovic, MD, PhD
role: Principal Investigator
affiliation: Region Skåne
last name: Jehns Martineus, MD
role: Study Director
affiliation: Skåne Universitets sjukhus, dept of rheumatology
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: meliha crnkic kapetanovic
investigator title: MD, PhD, associate professor
mesh term: Vasculitis
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
submitted: December 11, 2018
returned: March 21, 2019