<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/NCT01697007</url>
  </required_header>
  <id_info>
    <org_study_id>TaMoVac II</org_study_id>
    <nct_id>NCT01697007</nct_id>
  </id_info>
  <brief_title>A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique</brief_title>
  <acronym>TaMoVac II</acronym>
  <official_title>A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muhimbili University of Health and Allied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swedish Institute for Infectious Disease Control</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Military HIV Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Medical Research, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mbeya medical research program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Nacional de Saúde, Mozambique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Muhimbili University of Health and Allied Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electroporation will increase the efficiency of DNA priming in terms of immune responses and&#xD;
      will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine&#xD;
      concentration will reduce the number of shots necessary to deliver the full dose and induce&#xD;
      comparable immune responses as with lower DNA vaccine concentrations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The presence of an interferon gamma ELISpot responses to a pool of HIV peptides encoded by the vaccine to which there was no response at baseline</measure>
    <time_frame>2 weeks after the last vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Grade 3 or above local and systemic solicited adverse events</measure>
    <time_frame>Within 2 weeks post each immunization up to week 64 from enrollment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining</measure>
    <time_frame>2 weeks post last vaccination</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Any grade of adverse event that results in a clinical decision to discontinue further immunizations.</measure>
    <time_frame>After receiving the first immunization until 64 weeks from enrollment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The presence of HIV-specific binding antibodies and the titer when these are present</measure>
    <time_frame>Up to week 64 from enrollment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The presence of neutralizing antibodies and the titer when these are present</measure>
    <time_frame>Approximately between week 64-68 after enrollment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The magnitude of interferon gamma ELISpot responses measured by the number of spot forming cells per million PBMCs in response to pools of HIV-peptides in the assay</measure>
    <time_frame>2 weeks post the last vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Any grade of adverse event that occurs in a participant that has received at lease one immunization</measure>
    <time_frame>After the first immunization up to 64 weeks</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Vaccines</condition>
  <condition>HIV</condition>
  <condition>Safety</condition>
  <condition>Immunogenicity</condition>
  <arm_group>
    <arm_group_label>2 injections of DNA administered by Zetajet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 injections DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml followed by electroporation using the Derma Vax device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 injection DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive 600 micrograms of HIVIS DNA given in 1 injection using the Zetajet device the injection will comprise of 0.1 ml at a concentration of 6mg/ml followed by electroporation using the Derma Vax device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HIVIS DNA vaccine</intervention_name>
    <arm_group_label>1 injection DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_label>2 injections DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_label>2 injections of DNA administered by Zetajet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zetajet</intervention_name>
    <arm_group_label>1 injection DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_label>2 injections DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_label>2 injections of DNA administered by Zetajet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Derma Vax Electroporation</intervention_name>
    <arm_group_label>1 injection DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_label>2 injections DNA by Zetajet and electroporation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Modified Vaccinia Ankara (MVA-CDMR)</intervention_name>
    <arm_group_label>1 injection DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_label>2 injections DNA by Zetajet and electroporation</arm_group_label>
    <arm_group_label>2 injections of DNA administered by Zetajet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to undergo counselling and HIV testing.&#xD;
&#xD;
          -  Have a negative antigen/antibody ELISA for HIV infection.&#xD;
&#xD;
          -  Able to give informed consent.&#xD;
&#xD;
          -  Basic abilities to read and write.&#xD;
&#xD;
          -  Satisfactory completion of an assessment of understanding prior to enrolment defined&#xD;
             as 90% correct answers after three opportunities to take test.&#xD;
&#xD;
          -  Resident of the region where the study is taking place.&#xD;
&#xD;
          -  At low risk of HIV infection.&#xD;
&#xD;
          -  Verbal assurances for adequate birth control measures.&#xD;
&#xD;
          -  Healthy as evidenced by clinical and laboratory measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  At risk of HIV infection.&#xD;
&#xD;
          -  Active tuberculosis.&#xD;
&#xD;
          -  A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or&#xD;
             chronic illness requiring continuous or frequent medical intervention.&#xD;
&#xD;
          -  Autoimmune disease.&#xD;
&#xD;
          -  Hives and severe eczema.&#xD;
&#xD;
          -  Substance abuse problems.&#xD;
&#xD;
          -  History of grand-mal epilepsy.&#xD;
&#xD;
          -  Received blood or blood products or immunoglobulins in the past 3 months.&#xD;
&#xD;
          -  Receiving immunosuppressive therapy such as systemic corticosteroids or cancer&#xD;
             chemotherapy.&#xD;
&#xD;
          -  Use of experimental therapeutic agents within 30 days of study entry.&#xD;
&#xD;
          -  History of cardiac disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto Nacional de Saude</name>
      <address>
        <city>Maputo</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Muhimbili University of Health and Allied Sciences</name>
      <address>
        <city>Dar es Salaam</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mbeya Medical Research Programme</name>
      <address>
        <city>Mbeya</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mozambique</country>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>June 26, 2015</last_update_submitted>
  <last_update_submitted_qc>June 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Muhimbili University of Health and Allied Sciences</investigator_affiliation>
    <investigator_full_name>Patricia Jane Munseri</investigator_full_name>
    <investigator_title>Prof Eligius Lyamuya</investigator_title>
  </responsible_party>
  <!-- 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/NCT01697007
org study id: TaMoVac II
nct id: NCT01697007
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Electroporation will increase the efficiency of DNA priming in terms of immune responses and
      will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine
      concentration will reduce the number of shots necessary to deliver the full dose and induce
      comparable immune responses as with lower DNA vaccine concentrations.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The presence of an interferon gamma ELISpot responses to a pool of HIV peptides encoded by the vaccine to which there was no response at baseline
time frame: 2 weeks after the last vaccination
measure: Grade 3 or above local and systemic solicited adverse events
time frame: Within 2 weeks post each immunization up to week 64 from enrollment
measure: The presence of CD4+ and CD8+ T-cell cytokine responses to pools of HIV peptides assessed by Intracellular cytokine staining
time frame: 2 weeks post last vaccination
measure: Any grade of adverse event that results in a clinical decision to discontinue further immunizations.
time frame: After receiving the first immunization until 64 weeks from enrollment
measure: The presence of HIV-specific binding antibodies and the titer when these are present
time frame: Up to week 64 from enrollment
measure: The presence of neutralizing antibodies and the titer when these are present
time frame: Approximately between week 64-68 after enrollment
measure: The magnitude of interferon gamma ELISpot responses measured by the number of spot forming cells per million PBMCs in response to pools of HIV-peptides in the assay
time frame: 2 weeks post the last vaccination
measure: Any grade of adverse event that occurs in a participant that has received at lease one immunization
time frame: After the first immunization up to 64 weeks
arm group label: 2 injections of DNA administered by Zetajet
arm group type: Experimental
description: This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml
arm group label: 2 injections DNA by Zetajet and electroporation
arm group type: Experimental
description: This arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml followed by electroporation using the Derma Vax device.
arm group label: 1 injection DNA by Zetajet and electroporation
arm group type: Experimental
description: This arm will receive 600 micrograms of HIVIS DNA given in 1 injection using the Zetajet device the injection will comprise of 0.1 ml at a concentration of 6mg/ml followed by electroporation using the Derma Vax device.
intervention type: Biological
intervention name: HIVIS DNA vaccine
arm group label: 1 injection DNA by Zetajet and electroporation
arm group label: 2 injections DNA by Zetajet and electroporation
arm group label: 2 injections of DNA administered by Zetajet
intervention type: Device
intervention name: Zetajet
arm group label: 1 injection DNA by Zetajet and electroporation
arm group label: 2 injections DNA by Zetajet and electroporation
arm group label: 2 injections of DNA administered by Zetajet
intervention type: Device
intervention name: Derma Vax Electroporation
arm group label: 1 injection DNA by Zetajet and electroporation
arm group label: 2 injections DNA by Zetajet and electroporation
intervention type: Biological
intervention name: Modified Vaccinia Ankara (MVA-CDMR)
arm group label: 1 injection DNA by Zetajet and electroporation
arm group label: 2 injections DNA by Zetajet and electroporation
arm group label: 2 injections of DNA administered by Zetajet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Mozambique
country: Tanzania
responsible party type: Principal Investigator
investigator affiliation: Muhimbili University of Health and Allied Sciences
investigator full name: Patricia Jane Munseri
investigator title: Prof Eligius Lyamuya