<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/NCT03838497</url>
  </required_header>
  <id_info>
    <org_study_id>2014GR0014</org_study_id>
    <nct_id>NCT03838497</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults</brief_title>
  <official_title>Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults in the Era of Highly Active Antiretroviral Therapy: Analysis Stratified by CD4 T-cell Count</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Guro Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea University Guro Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases.&#xD;
      Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden,&#xD;
      but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years&#xD;
      were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell&#xD;
      counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts &lt;350 cells/µL). Multiplex&#xD;
      opsonophagocytic killing assay was used to compare immunogenicity after the immunization of&#xD;
      13-valent pneumococcal conjugate vaccine (PCV13).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-center, open-label non-randomized clinical trial was conducted at Korea&#xD;
      University Guro Hospital from April 2015 to January 2017. Based on the CD4 T-cell counts at&#xD;
      the time of study enrollment, HIV-infected subjects aged ≥ 18 years were divided into two&#xD;
      groups, group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with&#xD;
      CD4 T-cell counts &lt;350 cells/µL).&#xD;
&#xD;
      The primary objective of the study was to demonstrate that the immune responses to PCV13&#xD;
      serotypes in Group 2 (CD4 T-cell counts &lt;350 cells/µL) were not inferior to those in Group 1&#xD;
      (CD4 T-cell counts ≥350 cells/µL) at one month after vaccination. In addition, the safety&#xD;
      profiles of PCV13 were compared between two study groups.&#xD;
&#xD;
      HIV-infected subjects aged ≥ 18 years with stable underlying diseases (≥ 4 weeks on HAART)&#xD;
      were eligible for this study. All available subjects with low CD4 T-cell counts (&lt;350&#xD;
      cells/µL, group 2) were recruited, and age/visit day-matched controls with high CD4 T-cell&#xD;
      counts (≥350 cells/µL, group 1) were enrolled. The exclusion criteria were as follows: 1) a&#xD;
      history of pneumococcal infection within the recent five years, 2) previous pneumococcal&#xD;
      vaccination, 3) current opportunistic infections, 4) known immunodeficiency other than HIV&#xD;
      infection and 5) coagulation disorders.&#xD;
&#xD;
      The study was approved by the ethics committee of Korea University Guro Hospital (IRB No.&#xD;
      2014GR0014) and was conducted in accordance with the Declaration of Helsinki and Good&#xD;
      Clinical Practice. Informed consent was taken for all participants before enrollment. Venous&#xD;
      blood samples of 10 mL were collected on day 0 and post-vaccination day 28 ± 7.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2015</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opsonophagocytic assay (OPA) titers for PCV13</measure>
    <time_frame>Outcome measure will be assessed at two points (baseline and 28 ± 7 days after vaccination).</time_frame>
    <description>OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency and duration of local and systemic adverse events</measure>
    <time_frame>All participants will be followed until 4 weeks after vaccination</time_frame>
    <description>The safety profiles of co-administration of Fluad and PCV13 will be compared to those of single vaccination.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Streptococcal Pneumonia</condition>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>HIV-infected subjects with CD4 T-cell counts &lt;350 cells/µL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention to be administered: Prevenar13</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention to be administered: Prevenar13</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevenar13</intervention_name>
    <description>Prevenar13 for both arms</description>
    <arm_group_label>HIV-infected subjects with CD4 T-cell counts &lt;350 cells/µL</arm_group_label>
    <arm_group_label>HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infeted subjects who received antiretroviral therapy for ≥ 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of pneumococcal infection within the recent five years&#xD;
&#xD;
          -  previous pneumococcal vaccination&#xD;
&#xD;
          -  current opportunistic infections&#xD;
&#xD;
          -  known immunodeficiency other than HIV infection&#xD;
&#xD;
          -  coagulation disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Guro Hospital</investigator_affiliation>
    <investigator_full_name>Joon Young Song</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia, Pneumococcal</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>
  <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/NCT03838497
org study id: 2014GR0014
nct id: NCT03838497
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases.
      Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden,
      but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years
      were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell
      counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts <350 cells/µL). Multiplex
      opsonophagocytic killing assay was used to compare immunogenicity after the immunization of
      13-valent pneumococcal conjugate vaccine (PCV13).
This single-center, open-label non-randomized clinical trial was conducted at Korea
      University Guro Hospital from April 2015 to January 2017. Based on the CD4 T-cell counts at
      the time of study enrollment, HIV-infected subjects aged ≥ 18 years were divided into two
      groups, group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with
      CD4 T-cell counts <350 cells/µL).

      The primary objective of the study was to demonstrate that the immune responses to PCV13
      serotypes in Group 2 (CD4 T-cell counts <350 cells/µL) were not inferior to those in Group 1
      (CD4 T-cell counts ≥350 cells/µL) at one month after vaccination. In addition, the safety
      profiles of PCV13 were compared between two study groups.

      HIV-infected subjects aged ≥ 18 years with stable underlying diseases (≥ 4 weeks on HAART)
      were eligible for this study. All available subjects with low CD4 T-cell counts (<350
      cells/µL, group 2) were recruited, and age/visit day-matched controls with high CD4 T-cell
      counts (≥350 cells/µL, group 1) were enrolled. The exclusion criteria were as follows: 1) a
      history of pneumococcal infection within the recent five years, 2) previous pneumococcal
      vaccination, 3) current opportunistic infections, 4) known immunodeficiency other than HIV
      infection and 5) coagulation disorders.

      The study was approved by the ethics committee of Korea University Guro Hospital (IRB No.
      2014GR0014) and was conducted in accordance with the Declaration of Helsinki and Good
      Clinical Practice. Informed consent was taken for all participants before enrollment. Venous
      blood samples of 10 mL were collected on day 0 and post-vaccination day 28 ± 7.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Opsonophagocytic assay (OPA) titers for PCV13
time frame: Outcome measure will be assessed at two points (baseline and 28 ± 7 days after vaccination).
description: OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results
measure: Frequency and duration of local and systemic adverse events
time frame: All participants will be followed until 4 weeks after vaccination
description: The safety profiles of co-administration of Fluad and PCV13 will be compared to those of single vaccination.
arm group label: HIV-infected subjects with CD4 T-cell counts <350 cells/µL
arm group type: Active Comparator
description: Intervention to be administered: Prevenar13
arm group label: HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL
arm group type: Active Comparator
description: Intervention to be administered: Prevenar13
intervention type: Biological
intervention name: Prevenar13
description: Prevenar13 for both arms
arm group label: HIV-infected subjects with CD4 T-cell counts <350 cells/µL
arm group label: HIV-infected subjects with CD4 T-cell counts ≥350 cells/µL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Korea University Guro Hospital
investigator full name: Joon Young Song
investigator title: Professor
mesh term: Pneumonia, Pneumococcal
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: No