<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/NCT01686503</url>
  </required_header>
  <id_info>
    <org_study_id>Doris Duke CF-2012061</org_study_id>
    <nct_id>NCT01686503</nct_id>
  </id_info>
  <brief_title>Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects</brief_title>
  <acronym>IDIPV</acronym>
  <official_title>Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Virginia Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NanoPass Technologies Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Virginia Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a lower dose of inactivated polio vaccine&#xD;
      (IPV) injected into the skin (intradermal administration) can work equally well or better&#xD;
      than the standard dose injected into the muscle (intramuscular administration). There are&#xD;
      more immune cells in the skin than in the muscle, and other vaccines have been shown to&#xD;
      require a lower dose when administered intradermally. The study is being done in participants&#xD;
      infected with HIV because HIV-infected people are known to respond less well to vaccines than&#xD;
      other groups, so it is particularly important to know if IPV might work better in&#xD;
      HIV-infected people if administered intradermally.&#xD;
&#xD;
      If it is possible to lower the dose of IPV by intradermal administration, this would make&#xD;
      inactivated polio vaccine more affordable in the developing countries where it is most needed&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral polio vaccine (OPV) will not be sufficient to eradicate polio. OPV has failed to provide&#xD;
      adequate polio immunity in certain immunocompromised populations, such as people with AIDS.&#xD;
      Also, OPV can mutate and form neurovirulent strains capable of causing polio outbreaks.&#xD;
      Inactivated polio vaccine (IPV), which cannot mutate into neurovirulent strains and which is&#xD;
      more effective in populations that have failed to respond to OPV, will be needed globally to&#xD;
      eradicate polio, but it is unaffordable for many developing countries. Because there are more&#xD;
      immune cells in the skin than in the muscle, intradermal administration of IPV may be a way&#xD;
      to increase the efficacy and reduce the dose (and thus the cost) of IPV. We plan to conduct a&#xD;
      clinical trial randomizing 231 HIV-infected adults to receive a booster of two-fifths dose&#xD;
      intradermal IPV, one-fifth dose intradermal IPV, full dose intramuscular IPV, or two-fifths&#xD;
      dose intramuscular IPV. We will measure polio immunity before and after vaccine&#xD;
      administration. Through this study, we will determine the optimal booster dose of intradermal&#xD;
      IPV, whether intradermal works better than intramuscular IPV administration, and whether&#xD;
      intradermal IPV is effective in an immunocompromised population. The data from this trial&#xD;
      could contribute to global polio eradication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post Booster Polio Neutralizing Antibody Titers</measure>
    <time_frame>4-6 weeks after receiving the vaccine</time_frame>
    <description>Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline Polio Neutralizing Antibody Titers</measure>
    <time_frame>first visit</time_frame>
    <description>serum polio neutralizing antibody titers prior to the vaccine booster</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">231</enrollment>
  <condition>Polio Immunity</condition>
  <arm_group>
    <arm_group_label>2/5 dose intradermal IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1/5 dose intradermal IPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>full dose intramuscular IPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2/5 dose intramuscular IPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose</intervention_name>
    <description>Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
    <arm_group_label>1/5 dose intradermal IPV</arm_group_label>
    <arm_group_label>2/5 dose intradermal IPV</arm_group_label>
    <arm_group_label>2/5 dose intramuscular IPV</arm_group_label>
    <arm_group_label>full dose intramuscular IPV</arm_group_label>
    <other_name>IPOL (Sanofi Pasteur)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  documented HIV infection&#xD;
&#xD;
          -  age of at least 18 years old&#xD;
&#xD;
          -  HIV viral load &lt;400 on the most recent test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current acute moderate to severe illness (demonstrated by fever over 100.4 Fahrenheit,&#xD;
             shortness of breath, altered mental status, or by judgment of the primary clinician)&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  history of allergic reaction to a polio shot,&#xD;
&#xD;
          -  history of a life-threatening allergic reaction to neomycin, streptomycin, or&#xD;
             polymyxin B&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie B Troy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Virginia Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>C3ID Clinic, Eastern Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Troy SB, Kouiavskaia D, Siik J, Kochba E, Beydoun H, Mirochnitchenko O, Levin Y, Khardori N, Chumakov K, Maldonado Y. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. 2015 Jun 15;211(12):1969-76. doi: 10.1093/infdis/jiu841. Epub 2015 Jan 7.</citation>
    <PMID>25567841</PMID>
  </results_reference>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>January 13, 2015</results_first_submitted>
  <results_first_submitted_qc>January 22, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 5, 2015</results_first_posted>
  <last_update_submitted>January 22, 2015</last_update_submitted>
  <last_update_submitted_qc>January 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eastern Virginia Medical School</investigator_affiliation>
    <investigator_full_name>Stephanie Troy</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>2/5 Dose Intradermal IPV</title>
          <description>Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="P2">
          <title>1/5 Dose Intadermal IPV</title>
          <description>Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="P3">
          <title>Full Dose Intramuscular IPV</title>
          <description>Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="P4">
          <title>2/5 Dose Intramuscular IPV</title>
          <description>Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="63"/>
                <participants group_id="P3" count="64"/>
                <participants group_id="P4" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>2/5 Dose Intradermal IPV</title>
          <description>Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="B2">
          <title>1/5 Dose Intadermal IPV</title>
          <description>Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="B3">
          <title>Full Dose Intramuscular IPV</title>
          <description>Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="B4">
          <title>2/5 Dose Intramuscular IPV</title>
          <description>Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="B5">
          <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="66"/>
            <count group_id="B2" value="66"/>
            <count group_id="B3" value="66"/>
            <count group_id="B4" value="33"/>
            <count group_id="B5" value="231"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45" spread="10"/>
                    <measurement group_id="B2" value="45" spread="11"/>
                    <measurement group_id="B3" value="46" spread="11"/>
                    <measurement group_id="B4" value="46" spread="11"/>
                    <measurement group_id="B5" value="46" spread="11"/>
                  </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="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="66"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Most recent CD4 count</title>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="669" spread="361"/>
                    <measurement group_id="B2" value="630" spread="331"/>
                    <measurement group_id="B3" value="676" spread="354"/>
                    <measurement group_id="B4" value="569" spread="260"/>
                    <measurement group_id="B5" value="645" spread="338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Currently on antiretroviral therapy</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis of AIDS in the record</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Year diagnosed with HIV</title>
          <units>calendar year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2001" spread="8"/>
                    <measurement group_id="B2" value="2002" spread="8"/>
                    <measurement group_id="B3" value="2001" spread="8"/>
                    <measurement group_id="B4" value="2001" spread="9"/>
                    <measurement group_id="B5" value="2002" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Born in the United States</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lived or traveled internationally</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reported receiving all childhood vaccines</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current smoker</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coinfected with hepatitis C</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coinfected with hepatitis B</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post Booster Polio Neutralizing Antibody Titers</title>
        <description>Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.</description>
        <time_frame>4-6 weeks after receiving the vaccine</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2/5 Dose Intradermal IPV</title>
            <description>Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
          <group group_id="O2">
            <title>1/5 Dose Intadermal IPV</title>
            <description>Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose Intramuscular IPV</title>
            <description>Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
          <group group_id="O4">
            <title>2/5 Dose Intramuscular IPV</title>
            <description>Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
        </group_list>
        <measure>
          <title>Post Booster Polio Neutralizing Antibody Titers</title>
          <description>Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.</description>
          <units>antibody titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1715" lower_limit="1174" upper_limit="2504"/>
                    <measurement group_id="O2" value="976" lower_limit="730" upper_limit="1304"/>
                    <measurement group_id="O3" value="1249" lower_limit="916" upper_limit="1705"/>
                    <measurement group_id="O4" value="1328" lower_limit="795" upper_limit="2219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2188" lower_limit="1507" upper_limit="3178"/>
                    <measurement group_id="O2" value="1438" lower_limit="984" upper_limit="2101"/>
                    <measurement group_id="O3" value="1489" lower_limit="1041" upper_limit="2128"/>
                    <measurement group_id="O4" value="1938" lower_limit="1232" upper_limit="3047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2375" lower_limit="1423" upper_limit="3963"/>
                    <measurement group_id="O2" value="1698" lower_limit="1114" upper_limit="2588"/>
                    <measurement group_id="O3" value="1792" lower_limit="1133" upper_limit="2835"/>
                    <measurement group_id="O4" value="2075" lower_limit="1225" upper_limit="3514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Polio Neutralizing Antibody Titers</title>
        <description>serum polio neutralizing antibody titers prior to the vaccine booster</description>
        <time_frame>first visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2/5 Dose Intradermal IPV</title>
            <description>Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
          <group group_id="O2">
            <title>1/5 Dose Intadermal IPV</title>
            <description>Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
          <group group_id="O3">
            <title>Full Dose Intramuscular IPV</title>
            <description>Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
          <group group_id="O4">
            <title>2/5 Dose Intramuscular IPV</title>
            <description>Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Polio Neutralizing Antibody Titers</title>
          <description>serum polio neutralizing antibody titers prior to the vaccine booster</description>
          <units>antibody titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" lower_limit="31" upper_limit="64"/>
                    <measurement group_id="O2" value="42" lower_limit="29" upper_limit="59"/>
                    <measurement group_id="O3" value="42" lower_limit="30" upper_limit="58"/>
                    <measurement group_id="O4" value="34" lower_limit="20" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" lower_limit="24" upper_limit="44"/>
                    <measurement group_id="O2" value="53" lower_limit="37" upper_limit="76"/>
                    <measurement group_id="O3" value="36" lower_limit="26" upper_limit="51"/>
                    <measurement group_id="O4" value="44" lower_limit="29" upper_limit="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="10" upper_limit="20"/>
                    <measurement group_id="O2" value="20" lower_limit="14" upper_limit="28"/>
                    <measurement group_id="O3" value="16" lower_limit="11" upper_limit="21"/>
                    <measurement group_id="O4" value="11" lower_limit="7" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>2/5 Dose Intradermal IPV</title>
          <description>Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="E2">
          <title>1/5 Dose Intadermal IPV</title>
          <description>Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="E3">
          <title>Full Dose Intramuscular IPV</title>
          <description>Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
        <group group_id="E4">
          <title>2/5 Dose Intramuscular IPV</title>
          <description>Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.&#xD;
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for electrolyte imbalances secondary to alcohol withdrawal</sub_title>
                <description>Occured one month after receiving the vaccine</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</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="33" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Tenderness at Injection Site</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="66"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="66"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="66"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Redness at Injection Site</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="66"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="66"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Swelling at Injection Site</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="66"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Itching at injection site</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="66"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </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>
    <limitations_and_caveats>Higher baseline antibody titers than expected making it more difficult to detect differences between the study groups.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Stephanie Troy</name_or_title>
      <organization>Eastern Virginia Medical School</organization>
      <phone>757-446-8999</phone>
      <email>troysb@evms.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/NCT01686503
org study id: Doris Duke CF-2012061
nct id: NCT01686503
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether a lower dose of inactivated polio vaccine
      (IPV) injected into the skin (intradermal administration) can work equally well or better
      than the standard dose injected into the muscle (intramuscular administration). There are
      more immune cells in the skin than in the muscle, and other vaccines have been shown to
      require a lower dose when administered intradermally. The study is being done in participants
      infected with HIV because HIV-infected people are known to respond less well to vaccines than
      other groups, so it is particularly important to know if IPV might work better in
      HIV-infected people if administered intradermally.

      If it is possible to lower the dose of IPV by intradermal administration, this would make
      inactivated polio vaccine more affordable in the developing countries where it is most needed
Oral polio vaccine (OPV) will not be sufficient to eradicate polio. OPV has failed to provide
      adequate polio immunity in certain immunocompromised populations, such as people with AIDS.
      Also, OPV can mutate and form neurovirulent strains capable of causing polio outbreaks.
      Inactivated polio vaccine (IPV), which cannot mutate into neurovirulent strains and which is
      more effective in populations that have failed to respond to OPV, will be needed globally to
      eradicate polio, but it is unaffordable for many developing countries. Because there are more
      immune cells in the skin than in the muscle, intradermal administration of IPV may be a way
      to increase the efficacy and reduce the dose (and thus the cost) of IPV. We plan to conduct a
      clinical trial randomizing 231 HIV-infected adults to receive a booster of two-fifths dose
      intradermal IPV, one-fifth dose intradermal IPV, full dose intramuscular IPV, or two-fifths
      dose intramuscular IPV. We will measure polio immunity before and after vaccine
      administration. Through this study, we will determine the optimal booster dose of intradermal
      IPV, whether intradermal works better than intramuscular IPV administration, and whether
      intradermal IPV is effective in an immunocompromised population. The data from this trial
      could contribute to global polio eradication.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Post Booster Polio Neutralizing Antibody Titers
time frame: 4-6 weeks after receiving the vaccine
description: Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.
measure: Baseline Polio Neutralizing Antibody Titers
time frame: first visit
description: serum polio neutralizing antibody titers prior to the vaccine booster
arm group label: 2/5 dose intradermal IPV
arm group type: Experimental
description: Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device
arm group label: 1/5 dose intradermal IPV
arm group type: Experimental
description: Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.
arm group label: full dose intramuscular IPV
arm group type: Active Comparator
description: Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
arm group label: 2/5 dose intramuscular IPV
arm group type: Active Comparator
description: Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.
intervention type: Drug
intervention name: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
description: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.
arm group label: 1/5 dose intradermal IPV
arm group label: 2/5 dose intradermal IPV
arm group label: 2/5 dose intramuscular IPV
arm group label: full dose intramuscular IPV
other name: IPOL (Sanofi Pasteur)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Stephanie B Troy, MD
role: Principal Investigator
affiliation: Eastern Virginia Medical School
facility: 
country: United States
citation: Troy SB, Kouiavskaia D, Siik J, Kochba E, Beydoun H, Mirochnitchenko O, Levin Y, Khardori N, Chumakov K, Maldonado Y. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. 2015 Jun 15;211(12):1969-76. doi: 10.1093/infdis/jiu841. Epub 2015 Jan 7.
PMID: 25567841
responsible party type: Principal Investigator
investigator affiliation: Eastern Virginia Medical School
investigator full name: Stephanie Troy
investigator title: Assistant Professor
mesh term: Poliomyelitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Higher baseline antibody titers than expected making it more difficult to detect differences between the study groups.
point of contact: 