<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/NCT03041051</url>
  </required_header>
  <id_info>
    <org_study_id>51198eAS</org_study_id>
    <nct_id>NCT03041051</nct_id>
  </id_info>
  <brief_title>Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients</brief_title>
  <official_title>Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aghia Sophia Children's Hospital of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aghia Sophia Children's Hospital of Athens</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of a combined vaccination schedule of&#xD;
      the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine&#xD;
      (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)</measure>
    <time_frame>One month post-PCV13, PPV23</time_frame>
    <description>immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)</measure>
    <time_frame>One month post-PCV13, PPV23</time_frame>
    <description>immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>PCV13</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PPV23</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PCV13</intervention_name>
    <arm_group_label>PCV13</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PPV23</intervention_name>
    <arm_group_label>PPV23</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CD4 T cell count &gt;200cells/μl&#xD;
&#xD;
          -  on ART&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no previously recorded allergy to PCV, PPV23&#xD;
&#xD;
          -  no intravenous immunoglobulin (IVIG) given within the previous 6 months&#xD;
&#xD;
          -  no other vaccine given within the previous 6 months&#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>Vana Spoulou</last_name>
    <role>Principal Investigator</role>
    <affiliation>Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527</affiliation>
  </overall_official>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aghia Sophia Children's Hospital of Athens</investigator_affiliation>
    <investigator_full_name>Vana Spoulou</investigator_full_name>
    <investigator_title>Associate Professor of Pediatric Infectious Diseases</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03041051
org study id: 51198eAS
nct id: NCT03041051
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the effect of a combined vaccination schedule of
      the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine
      (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
time frame: One month post-PCV13, PPV23
description: immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
measure: immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
time frame: One month post-PCV13, PPV23
description: immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
arm group label: PCV13
arm group type: Experimental
arm group label: PPV23
arm group type: Experimental
intervention type: Biological
intervention name: PCV13
arm group label: PCV13
intervention type: Biological
intervention name: PPV23
arm group label: PPV23
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vana Spoulou
role: Principal Investigator
affiliation: Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527
responsible party type: Principal Investigator
investigator affiliation: Aghia Sophia Children's Hospital of Athens
investigator full name: Vana Spoulou
investigator title: Associate Professor of Pediatric Infectious Diseases
mesh term: HIV Infections
sharing ipd: No