<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/NCT01705990</url>
  </required_header>
  <id_info>
    <org_study_id>IAVI S001</org_study_id>
    <nct_id>NCT01705990</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers</brief_title>
  <official_title>A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International AIDS Vaccine Initiative</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International AIDS Vaccine Initiative</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, tolerability and immunogenicity of&#xD;
      Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in&#xD;
      prime-boost regimens in HIV-uninfected, healthy adult volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing&#xD;
      the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and&#xD;
      Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.&#xD;
&#xD;
      Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for&#xD;
      12 months after the last vaccine administration (16 months after the first vaccination). It&#xD;
      is anticipated that it will take approximately 6 months to enroll the study. Approximately 64&#xD;
      volunteers (48 vaccine and 16 placebo recipients) will be included in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability</measure>
    <time_frame>16 months approximately</time_frame>
    <description>To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shedding</measure>
    <time_frame>16 months</time_frame>
    <description>To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>16 months</time_frame>
    <description>To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Group A: SeV-G(NP) followed by Ad35-GRIN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SeV-G(NP) (IN) at 2x10^7 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: SeV-G(NP) followed by Ad35-GRIN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C: Ad35-GRIN followed by SeV-G(NP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ad35-GRIN (IM) at 1x10^10 vp at Month 0 followed by SeV-G(NP) (IN) at 2x10^8 CIU at Month 4. (Vaccine/Placebo = 12/4)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D: SeV-G(NP) only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SeV-G(NP) (0.2mL, 2x10^7 CIU)</intervention_name>
    <description>Delivered intranasally by drops</description>
    <arm_group_label>Group A: SeV-G(NP) followed by Ad35-GRIN</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SeV-G(NP) (0.2mL, 2x10^8 CIU)</intervention_name>
    <description>Delivered intranasally by drops</description>
    <arm_group_label>Group B: SeV-G(NP) followed by Ad35-GRIN</arm_group_label>
    <arm_group_label>Group C: Ad35-GRIN followed by SeV-G(NP)</arm_group_label>
    <arm_group_label>Group D: SeV-G(NP) only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ad35-GRIN (0.5mL)</intervention_name>
    <description>(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection</description>
    <arm_group_label>Group A: SeV-G(NP) followed by Ad35-GRIN</arm_group_label>
    <arm_group_label>Group B: SeV-G(NP) followed by Ad35-GRIN</arm_group_label>
    <arm_group_label>Group C: Ad35-GRIN followed by SeV-G(NP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy male or female adults,&#xD;
&#xD;
          -  18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda),&#xD;
&#xD;
          -  who do not report high-risk behaviour for HIV infection,&#xD;
&#xD;
          -  who are available for the duration of the trial,&#xD;
&#xD;
          -  who are willing to undergo HIV testing,&#xD;
&#xD;
          -  use an effective method of contraception, and&#xD;
&#xD;
          -  who, in the opinion of the principal investigator or designee, understand the study&#xD;
             and who provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  confirmed HIV infection,&#xD;
&#xD;
          -  pregnancy and lactation,&#xD;
&#xD;
          -  significant acute or chronic disease,&#xD;
&#xD;
          -  clinically significant laboratory abnormalities,&#xD;
&#xD;
          -  recent vaccination or receipt of a blood product,&#xD;
&#xD;
          -  previous receipt of an HIV vaccine, and&#xD;
&#xD;
          -  previous severe local or systemic reactions to vaccination or history of severe&#xD;
             allergic reactions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kenya AIDS Vaccine Initiative</name>
      <address>
        <city>Nairobi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Project San Francisco</name>
      <address>
        <city>Kigali</city>
        <country>Rwanda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Stephen's Centre</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
    <country>Rwanda</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.iavi.org</url>
    <description>International AIDS Vaccine Initiative</description>
  </link>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>August 25, 2015</last_update_submitted>
  <last_update_submitted_qc>August 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>AIDS</keyword>
  <keyword>HIV vaccine</keyword>
  <keyword>HIV prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01705990
org study id: IAVI S001
nct id: NCT01705990
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of
      Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in
      prime-boost regimens in HIV-uninfected, healthy adult volunteers.
The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing
      the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and
      Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.

      Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for
      12 months after the last vaccine administration (16 months after the first vaccination). It
      is anticipated that it will take approximately 6 months to enroll the study. Approximately 64
      volunteers (48 vaccine and 16 placebo recipients) will be included in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with adverse events as a measure of safety and tolerability
time frame: 16 months approximately
description: To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens.
measure: Shedding
time frame: 16 months
description: To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert
measure: Immunogenicity
time frame: 16 months
description: To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.
arm group label: Group A: SeV-G(NP) followed by Ad35-GRIN
arm group type: Experimental
description: SeV-G(NP) (IN) at 2x10^7 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
arm group label: Group B: SeV-G(NP) followed by Ad35-GRIN
arm group type: Experimental
description: SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4)
arm group label: Group C: Ad35-GRIN followed by SeV-G(NP)
arm group type: Experimental
description: Ad35-GRIN (IM) at 1x10^10 vp at Month 0 followed by SeV-G(NP) (IN) at 2x10^8 CIU at Month 4. (Vaccine/Placebo = 12/4)
arm group label: Group D: SeV-G(NP) only
arm group type: Experimental
description: SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)
intervention type: Biological
intervention name: SeV-G(NP) (0.2mL, 2x10^7 CIU)
description: Delivered intranasally by drops
arm group label: Group A: SeV-G(NP) followed by Ad35-GRIN
intervention type: Biological
intervention name: SeV-G(NP) (0.2mL, 2x10^8 CIU)
description: Delivered intranasally by drops
arm group label: Group B: SeV-G(NP) followed by Ad35-GRIN
arm group label: Group C: Ad35-GRIN followed by SeV-G(NP)
arm group label: Group D: SeV-G(NP) only
intervention type: Biological
intervention name: Ad35-GRIN (0.5mL)
description: (1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
arm group label: Group A: SeV-G(NP) followed by Ad35-GRIN
arm group label: Group B: SeV-G(NP) followed by Ad35-GRIN
arm group label: Group C: Ad35-GRIN followed by SeV-G(NP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Kenya
country: Rwanda
country: United Kingdom
url: http://www.iavi.org
description: International AIDS Vaccine Initiative
responsible party type: Sponsor
mesh term: HIV Infections