<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/NCT03260790</url>
  </required_header>
  <id_info>
    <org_study_id>16-007731</org_study_id>
    <nct_id>NCT03260790</nct_id>
  </id_info>
  <brief_title>Pneumococcal Vaccines in Patients With Asthma</brief_title>
  <official_title>Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine&#xD;
      if they are given Prevnar initially.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone&#xD;
      (Active comparator). At the Week 0 time point, the patients will receive either PCV13&#xD;
      (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment&#xD;
      of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood&#xD;
      for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group&#xD;
      will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype&#xD;
      titers as well as a blood draw at week 16 and week 24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</primary_completion_date>
  <phase>Phase 4</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>Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16</measure>
    <time_frame>Baseline, week 0, week 8, week 16</time_frame>
    <description>5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16</measure>
    <time_frame>Baseline, week 0, week 8, week 16</time_frame>
    <description>5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16</measure>
    <time_frame>Baseline, week 0, week 8, week 16</time_frame>
    <description>5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 &amp; PPSV23. Measured as mcg/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.</measure>
    <time_frame>Baseline, week 0, week 8, week 16</time_frame>
    <description>5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>PCV13 and PPSV23</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPSV23</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to receive PPSV23 alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PCV13</intervention_name>
    <description>Single 0.5 ml dose of PCV13 administered via intramuscular injection</description>
    <arm_group_label>PCV13 and PPSV23</arm_group_label>
    <other_name>Prevnar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PPSV23</intervention_name>
    <description>Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
    <arm_group_label>PCV13 and PPSV23</arm_group_label>
    <arm_group_label>PPSV23</arm_group_label>
    <other_name>Pneumovax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Diagnosis of asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Research exemption requested&#xD;
&#xD;
          -  History of PCV-13 vaccination&#xD;
&#xD;
          -  History of cochlear implant&#xD;
&#xD;
          -  Cerebrospinal Fluid (CSF) leak&#xD;
&#xD;
          -  Congestive Heart Failure (CHF)&#xD;
&#xD;
          -  Diabetes Mellitus (DM)&#xD;
&#xD;
          -  Chronic Kidney Disease (CKD)&#xD;
&#xD;
          -  Human Immunodeficiency Virus (HIV)&#xD;
&#xD;
          -  Common Variable Immune Deficiency (CVID)&#xD;
&#xD;
          -  Patients who have received the PPSV23 vaccine in the last 5 years&#xD;
&#xD;
          -  Women who are pregnant will also be excluded from the study by performing 2 point of&#xD;
             care urine pregnancy tests ( prior to vaccinations)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avni Y Joshi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <results_first_submitted>October 7, 2021</results_first_submitted>
  <results_first_submitted_qc>October 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 5, 2021</results_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Avni Joshi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vaccine</keyword>
  <keyword>Pneumococcal</keyword>
  <keyword>Pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03260790/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PCV13 and PPSV23</title>
          <description>Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23&#xD;
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously</description>
        </group>
        <group group_id="P2">
          <title>PPSV23</title>
          <description>Participants received PPSV23 alone&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PCV13 and PPSV23</title>
          <description>Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23&#xD;
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously</description>
        </group>
        <group group_id="B2">
          <title>PPSV23</title>
          <description>Participants received PPSV23 alone&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16</title>
        <description>5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.</description>
        <time_frame>Baseline, week 0, week 8, week 16</time_frame>
        <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
        <group_list>
          <group group_id="O1">
            <title>PCV13 and PPSV23</title>
            <description>Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23&#xD;
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>PPSV23</title>
            <description>Participants received PPSV23 alone&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16</title>
          <description>5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.</description>
          <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
          <units>mcg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.8" lower_limit="74.3" upper_limit="141.8"/>
                    <measurement group_id="O2" value="53.9" lower_limit="34.8" upper_limit="185.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.3" lower_limit="111.7" upper_limit="194.6"/>
                    <measurement group_id="O2" value="53.9" lower_limit="34.8" upper_limit="185.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211.7" lower_limit="184.6" upper_limit="271.0"/>
                    <measurement group_id="O2" value="243.3" lower_limit="173.4" upper_limit="271.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212.0" lower_limit="171.1" upper_limit="257.7"/>
                    <measurement group_id="O2" value="224.8" lower_limit="196.6" upper_limit="271.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16</title>
        <description>5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.</description>
        <time_frame>Baseline, week 0, week 8, week 16</time_frame>
        <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
        <group_list>
          <group group_id="O1">
            <title>PCV13 and PPSV23</title>
            <description>Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23&#xD;
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>PPSV23</title>
            <description>Participants received PPSV23 alone&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16</title>
          <description>5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.</description>
          <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
          <units>mcg/mL.</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228.0" lower_limit="174.2" upper_limit="362.3"/>
                    <measurement group_id="O2" value="206.8" lower_limit="130.1" upper_limit="323.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.3" lower_limit="349.6" upper_limit="670.9"/>
                    <measurement group_id="O2" value="206.8" lower_limit="130.1" upper_limit="323.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="502.9" lower_limit="369.9" upper_limit="790.5"/>
                    <measurement group_id="O2" value="449.4" lower_limit="338.7" upper_limit="583.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="534.8" lower_limit="325.4" upper_limit="688.4"/>
                    <measurement group_id="O2" value="485.7" lower_limit="321.2" upper_limit="588.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16</title>
        <description>5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 &amp; PPSV23. Measured as mcg/mL.</description>
        <time_frame>Baseline, week 0, week 8, week 16</time_frame>
        <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
        <group_list>
          <group group_id="O1">
            <title>PCV13 and PPSV23</title>
            <description>Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23&#xD;
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>PPSV23</title>
            <description>Participants received PPSV23 alone&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16</title>
          <description>5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 &amp; PPSV23. Measured as mcg/mL.</description>
          <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
          <units>mcg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.4" lower_limit="110.7" upper_limit="246.8"/>
                    <measurement group_id="O2" value="107.4" lower_limit="92.9" upper_limit="161.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="418.9" lower_limit="303.2" upper_limit="525.1"/>
                    <measurement group_id="O2" value="107.4" lower_limit="92.9" upper_limit="161.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="362.8" lower_limit="258.9" upper_limit="498.6"/>
                    <measurement group_id="O2" value="229.4" lower_limit="162.6" upper_limit="302.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343.7" lower_limit="221.5" upper_limit="447.1"/>
                    <measurement group_id="O2" value="230.5" lower_limit="149.5" upper_limit="302.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.</title>
        <description>5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.</description>
        <time_frame>Baseline, week 0, week 8, week 16</time_frame>
        <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
        <group_list>
          <group group_id="O1">
            <title>PCV13 and PPSV23</title>
            <description>Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23&#xD;
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously</description>
          </group>
          <group group_id="O2">
            <title>PPSV23</title>
            <description>Participants received PPSV23 alone&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
          </group>
        </group_list>
        <measure>
          <title>Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.</title>
          <description>5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.</description>
          <population>Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.</population>
          <units>mcg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2" lower_limit="64.1" upper_limit="120.9"/>
                    <measurement group_id="O2" value="74.7" lower_limit="41.0" upper_limit="160.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4" lower_limit="56.2" upper_limit="152.4"/>
                    <measurement group_id="O2" value="74.7" lower_limit="41.0" upper_limit="160.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174.2" lower_limit="92.3" upper_limit="283.4"/>
                    <measurement group_id="O2" value="220.0" lower_limit="164.7" upper_limit="246.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.1" lower_limit="96.9" upper_limit="277.0"/>
                    <measurement group_id="O2" value="184.1" lower_limit="171.0" upper_limit="255.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from baseline to end of study, approximately 16 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PCV13 and PPSV23</title>
          <description>Participants received PPSV23 primed with PCV13&#xD;
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously</description>
        </group>
        <group group_id="E2">
          <title>PPSV23</title>
          <description>Participants received PPSV23 alone&#xD;
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Avni Y. Joshi, M.D., M.S.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-3165</phone>
      <email>Joshi.Avni@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03260790
org study id: 16-007731
nct id: NCT03260790
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine
      if they are given Prevnar initially.
Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone
      (Active comparator). At the Week 0 time point, the patients will receive either PCV13
      (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment
      of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood
      for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group
      will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype
      titers as well as a blood draw at week 16 and week 24.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
time frame: Baseline, week 0, week 8, week 16
description: 5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
measure: Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
time frame: Baseline, week 0, week 8, week 16
description: 5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
measure: Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
time frame: Baseline, week 0, week 8, week 16
description: 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 & PPSV23. Measured as mcg/mL.
measure: Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
time frame: Baseline, week 0, week 8, week 16
description: 5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.
arm group label: PCV13 and PPSV23
arm group type: Experimental
description: Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
arm group label: PPSV23
arm group type: Active Comparator
description: Participants randomized to receive PPSV23 alone
intervention type: Biological
intervention name: PCV13
description: Single 0.5 ml dose of PCV13 administered via intramuscular injection
arm group label: PCV13 and PPSV23
other name: Prevnar
intervention type: Biological
intervention name: PPSV23
description: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
arm group label: PCV13 and PPSV23
arm group label: PPSV23
other name: Pneumovax
criteria: 
gender: All
minimum age: 19 Years
maximum age: 64 Years
healthy volunteers: No
last name: Avni Y Joshi
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Avni Joshi
investigator title: Principal Investigator
mesh term: Asthma
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 