<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/NCT01687595</url>
  </required_header>
  <id_info>
    <org_study_id>C-400-02</org_study_id>
    <nct_id>NCT01687595</nct_id>
  </id_info>
  <brief_title>Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes</brief_title>
  <official_title>A Phase 2a, Multicenter, Double-blinded, Randomized, 2-Period Trial to Evaluate the Effect of HerpV Administered in Combination With the Stimulon® Adjuvant QS-21 on Viral Shedding in Adults With Recurrent Genital Herpes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Agenus Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Agenus Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of recombinant human heat shock protein&#xD;
      70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital&#xD;
      herpes by evaluating viral shedding before and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the biological effectiveness and safety of the HerpV vaccine in&#xD;
      combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be&#xD;
      evaluated by collecting number and severity of adverse events throughout the study.&#xD;
&#xD;
      Participants will undergo a baseline/ screening period. This is a 45 day period when the&#xD;
      participant collects a swab of the genital area each day. In case of a recurrence,&#xD;
      participant will be required to collect two swabs a day. If the participant collects at least&#xD;
      80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.&#xD;
&#xD;
      Study Period 1 consists of three treatments and a 45 day swabbing period after the last&#xD;
      treatment. The participant will collect swabs of the genital region each day for 45 days.&#xD;
&#xD;
      Participants who successfully complete Study Period 1 will proceed to Study Period 2. They&#xD;
      will receive a booster injection of study drug or placebo according to their original&#xD;
      randomization assignment. The participants will again enter a 45 day swabbing period,&#xD;
      collecting swabs of the genital area each day for 45 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)</measure>
    <time_frame>Baseline, Weeks 6-13</time_frame>
    <description>The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs.&#xD;
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.&#xD;
Percent change in viral shedding rate and 95% CI are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)</measure>
    <time_frame>Baseline, Weeks 26-33</time_frame>
    <description>The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs.&#xD;
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.&#xD;
Percent change in viral shedding rate and 95% CI are reported.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time</measure>
    <time_frame>Baseline through Week 26</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With CD8+ Immune Response at Any Time</measure>
    <time_frame>Baseline through Week 26</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Herpes Simplex Type 2</condition>
  <arm_group>
    <arm_group_label>HerpV 240 μg + QS-21 50 μg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a combination of HerpV 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 will receive a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period will be followed by a washout period of 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a placebo injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period will be followed by a washout period of 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HerpV and QS-21</intervention_name>
    <description>HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) in combination with adjuvant QS-21</description>
    <arm_group_label>HerpV 240 μg + QS-21 50 μg</arm_group_label>
    <other_name>AG-707</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>phosphate buffered saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Seropositive for herpes simplex virus type 2 (HSV-2)&#xD;
&#xD;
          -  Clinically active genital herpes defined as a history of 1-9 episodes per year for at&#xD;
             least 1 year prior to screening or 1 year prior to beginning suppressive therapy.&#xD;
&#xD;
          -  Willing to either use an effective method of contraception or abstain from sexual&#xD;
             intercourse throughout the 48-week study period.&#xD;
&#xD;
          -  If female of childbearing potential, have a negative serum pregnancy test.&#xD;
&#xD;
          -  Agree to not receive any other investigational drugs while enrolled in this study.&#xD;
&#xD;
          -  The above criteria must be met before participants are allowed to enter the 45-day&#xD;
             swabbing period to be screen for the study.&#xD;
&#xD;
          -  Completion and collection of greater than or equal to 80% (36 days) of the 45-day&#xD;
             consecutive daily genital swabs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe active infection, compromised cardiopulmonary function, or other serious&#xD;
             medical illness that, in the opinion of the principal investigator, would prevent&#xD;
             study completion.&#xD;
&#xD;
          -  A history of herpes simplex virus (HSV) infection of the eye (herpes simplex&#xD;
             interstitial keratitis or uveitis), or herpes-associated erythema multiforme.&#xD;
&#xD;
          -  A history of immune suppression or autoimmune disorder.&#xD;
&#xD;
          -  Continued use of suppressive anti-viral therapy for HSV-2; a 1 week washout of any&#xD;
             anti-viral therapy (suppressive and episodic) is required prior to initiating the&#xD;
             swabbing period.&#xD;
&#xD;
          -  Concomitant use of systemic corticosteroids or immune-suppressive medications. The use&#xD;
             of nasal steroids is acceptable.&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) positive.&#xD;
&#xD;
          -  Presence of active Hepatitis B or C infection.&#xD;
&#xD;
          -  Known hypersensitivity or allergies to acyclovir or valacyclovir.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Agenus Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Agenus Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westover Heights Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies - Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies - Cypress</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies- Webster</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Virology Research Clinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wald A, Koelle DM, Fife K, Warren T, Leclair K, Chicz RM, Monks S, Levey DL, Musselli C, Srivastava PK. Safety and immunogenicity of long HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons. Vaccine. 2011 Nov 3;29(47):8520-9. doi: 10.1016/j.vaccine.2011.09.046. Epub 2011 Sep 21.</citation>
    <PMID>21945262</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>May 26, 2021</results_first_submitted>
  <results_first_submitted_qc>June 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 13, 2021</results_first_posted>
  <disposition_first_submitted>January 12, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>January 12, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 26, 2015</disposition_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>herpes simplex virus type 2,</keyword>
  <keyword>genital herpes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Herpes Genitalis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HerpV + QS-21</title>
          <description>Participants received a combination of HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received placebo (phosphate buffered saline [PBS]) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor's decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.</population>
      <group_list>
        <group group_id="B1">
          <title>HerpV + QS-21</title>
          <description>Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.</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="70"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="80"/>
          </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="35.9" spread="8.00"/>
                    <measurement group_id="B2" value="33.7" spread="6.22"/>
                    <measurement group_id="B3" value="35.6" spread="7.80"/>
                  </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="42"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)</title>
        <description>The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs.&#xD;
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.&#xD;
Percent change in viral shedding rate and 95% CI are reported.</description>
        <time_frame>Baseline, Weeks 6-13</time_frame>
        <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for &quot;HerpV + QS-21&quot; arm only.</population>
        <group_list>
          <group group_id="O1">
            <title>HerpV + QS-21</title>
            <description>Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)</title>
          <description>The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs.&#xD;
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.&#xD;
Percent change in viral shedding rate and 95% CI are reported.</description>
          <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for &quot;HerpV + QS-21&quot; arm only.</population>
          <units>percentage change</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.53" lower_limit="2.38" upper_limit="23.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)</title>
        <description>The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs.&#xD;
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.&#xD;
Percent change in viral shedding rate and 95% CI are reported.</description>
        <time_frame>Baseline, Weeks 26-33</time_frame>
        <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for &quot;HerpV + QS-21&quot; arm only.</population>
        <group_list>
          <group group_id="O1">
            <title>HerpV + QS-21</title>
            <description>Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)</title>
          <description>The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs.&#xD;
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.&#xD;
Percent change in viral shedding rate and 95% CI are reported.</description>
          <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for &quot;HerpV + QS-21&quot; arm only.</population>
          <units>percentage change</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.78" lower_limit="0.83" upper_limit="23.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time</title>
        <time_frame>Baseline through Week 26</time_frame>
        <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>HerpV + QS-21</title>
            <description>Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time</title>
          <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With CD8+ Immune Response at Any Time</title>
        <time_frame>Baseline through Week 26</time_frame>
        <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>HerpV + QS-21</title>
            <description>Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With CD8+ Immune Response at Any Time</title>
          <population>Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 76</time_frame>
      <desc>Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.</desc>
      <group_list>
        <group group_id="E1">
          <title>HerpV + QS-21</title>
          <description>Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="67" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperacusis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Thyroid mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eyelid edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain, upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aphthous stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paresthesia, oral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tongue disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tooth impacted</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Induration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza-like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site erythema</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site hematoma</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site induration</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site pain</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site swelling</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site vesicles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection-site warmth</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vaccination-site warmth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertransaminasemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chlamydial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis, viral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pharyngitis, streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash, pustular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vaginal abscess</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood growth hormone decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Axillary mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer, in situ</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rectal cancer, stage II</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Mid-cycle spotting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cervical polyp</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Menstrual disorder</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Penile pain</sub_title>
                <description>This is a gender specific AE that affects only male participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Sexual dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vaginal laceration</sub_title>
                <description>This is a gender specific AE that affects only female participants.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cold sweat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis, contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema, multiforme</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pruritis, generalized</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash, pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS 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>Agenus, Inc. Clinical Trial Information</name_or_title>
      <organization>Agenus Inc.</organization>
      <phone>781-674-4265</phone>
      <email>clinicaltrialinfo@Agenusbio.com</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/NCT01687595
org study id: C-400-02
nct id: NCT01687595
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of recombinant human heat shock protein
      70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital
      herpes by evaluating viral shedding before and after treatment.
This study will evaluate the biological effectiveness and safety of the HerpV vaccine in
      combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be
      evaluated by collecting number and severity of adverse events throughout the study.

      Participants will undergo a baseline/ screening period. This is a 45 day period when the
      participant collects a swab of the genital area each day. In case of a recurrence,
      participant will be required to collect two swabs a day. If the participant collects at least
      80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.

      Study Period 1 consists of three treatments and a 45 day swabbing period after the last
      treatment. The participant will collect swabs of the genital region each day for 45 days.

      Participants who successfully complete Study Period 1 will proceed to Study Period 2. They
      will receive a booster injection of study drug or placebo according to their original
      randomization assignment. The participants will again enter a 45 day swabbing period,
      collecting swabs of the genital area each day for 45 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)
time frame: Baseline, Weeks 6-13
description: The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs.
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.
Percent change in viral shedding rate and 95% CI are reported.
measure: Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)
time frame: Baseline, Weeks 26-33
description: The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs.
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants.
Percent change in viral shedding rate and 95% CI are reported.
measure: Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time
time frame: Baseline through Week 26
measure: Number of Participants With CD8+ Immune Response at Any Time
time frame: Baseline through Week 26
arm group label: HerpV 240 μg + QS-21 50 μg
arm group type: Experimental
description: Participants will receive a combination of HerpV 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 will receive a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period will be followed by a washout period of 1 week.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive a placebo injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period will be followed by a washout period of 1 week.
intervention type: Drug
intervention name: HerpV and QS-21
description: HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) in combination with adjuvant QS-21
arm group label: HerpV 240 μg + QS-21 50 μg
other name: AG-707
intervention type: Drug
intervention name: Placebo
description: phosphate buffered saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Agenus Medical Monitor
role: Study Director
affiliation: Agenus Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Wald A, Koelle DM, Fife K, Warren T, Leclair K, Chicz RM, Monks S, Levey DL, Musselli C, Srivastava PK. Safety and immunogenicity of long HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons. Vaccine. 2011 Nov 3;29(47):8520-9. doi: 10.1016/j.vaccine.2011.09.046. Epub 2011 Sep 21.
PMID: 21945262
responsible party type: Sponsor
mesh term: Herpes Simplex
mesh term: Herpes Genitalis
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 