<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/NCT01705223</url>
  </required_header>
  <id_info>
    <org_study_id>X111012202</org_study_id>
    <nct_id>NCT01705223</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)</brief_title>
  <official_title>Phase IIa Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Center for AIDS/STD Control and Prevention, China CDC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Center for AIDS/STD Control and Prevention, China CDC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by&#xD;
      recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk&#xD;
      of HIV infection. In addition, the effect of different intervals of the prime-boost will be&#xD;
      studied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">October 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence, intensity and relationship to vaccination of local and general adverse events</measure>
    <time_frame>14-day follow-up after DNA vaccine vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence and relationship to vaccination of any serious AEs (SAEs)</measure>
    <time_frame>During the study period (Month 0-20)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)</measure>
    <time_frame>During the study period (Month 0-20)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>test HIV specific T cell response by ELISPOT</measure>
    <time_frame>2wk, 4wk, 14wk, 24wk after rTV vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>test HIV specific antibody by ELISA</measure>
    <time_frame>2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence, intensity and relationship to vaccination of local and general adverse events</measure>
    <time_frame>28-day follow-up after rTV vaccination</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>test HIV specific T cell response by ICS</measure>
    <time_frame>4wk, 8wk, 14wk, 48wk after rTV vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV neutralizing antibody test</measure>
    <time_frame>4wk, 14wk, 48wk after rTV vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vaccinia virus antibody test</measure>
    <time_frame>2wk, 4wk, 24wk after rTV vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>AIDS</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DNA vaccine prime at week 0,4,8 and rTV boost at week 16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DNA vaccine prime at week 0,4,8 and rTV boost at week 24</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DNA vaccine prime at week 0,4,8 and rTV boost at week 32</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DNA vaccine</intervention_name>
    <description>4mg/dose, three doses at week 0,4,8</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DNA vaccine prime with the addition of electroporation</intervention_name>
    <description>4mg/dose, three doses at week 0,4,8</description>
    <arm_group_label>group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>rTV boost</intervention_name>
    <description>at week 16</description>
    <arm_group_label>group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>rTV boost</intervention_name>
    <description>at week 24</description>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>rTV boost</intervention_name>
    <description>at week 32</description>
    <arm_group_label>group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to be followed for the planned duration of the study, and receive intravenous&#xD;
             blood collection and sample storage in the 16~20 months after first vaccination;&#xD;
&#xD;
          -  Understand and agree with the content of informed consent;&#xD;
&#xD;
          -  Volunteers at low risk of HIV infection, or high-risk men who have sex with men (MSM）,&#xD;
             who had have oral sex or anal sex with another man in the past 6 months ;&#xD;
&#xD;
          -  Willing to be tested for HIV and syphilis;&#xD;
&#xD;
          -  Before 2 weeks of the first vaccination and after 12 months of the last vaccination,&#xD;
             willing to use an effective method of contraception with sexual partner. Female&#xD;
             subjects are willing to undergo urine pregnancy test before each vaccination and at&#xD;
             the follow-up visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have close contact with people who are pregnant or lactating in the one month after&#xD;
             vaccination of rTV vaccine;&#xD;
&#xD;
          -  Have listed diseases or medical history:&#xD;
&#xD;
               -  Have innate or acquired immune deficiency disease or have close contact with&#xD;
                  patients suffering from the above-mentioned diseases within 1 month of rTV&#xD;
                  vaccination;&#xD;
&#xD;
               -  Need treatment affecting immunization, e.g. use corticosteroids for more than 2&#xD;
                  weeks or use immunosuppressives, e.g. alkylating, anti-metabolite or&#xD;
                  radiotherapy, etc.; or have close contact with patients suffering from the&#xD;
                  above-mentioned diseases within 1 month of rTV vaccination;&#xD;
&#xD;
               -  Suffering from immunosuppressive diseases such as cancer, organ or stem cell&#xD;
                  transplants, non-agammaglobulinemia, etc.; or have close contact with patients&#xD;
                  suffering from the above-mentioned diseases within 1 month of rTV vaccination;&#xD;
&#xD;
               -  Past or current suffering from eczema or atopic dermatitis; currently suffering&#xD;
                  from diseases that cause skin damage such as: burns, scald, chicken pox,&#xD;
                  impetigo, shingles, psoriasis, etc.; or have close contact with patients&#xD;
                  suffering from the above-mentioned diseases within 1 month of rTV vaccination;&#xD;
&#xD;
               -  Past or current high blood pressure, heart disease, diabetes, thyroid disease,&#xD;
                  asthma, angioedema, asplenia syndrome, mental illness, epilepsy, severe anemia,&#xD;
                  leukopenia and thrombocytopenia, etc.;&#xD;
&#xD;
               -  History of syncope after vaccination or allergies;&#xD;
&#xD;
               -  Currently suffering from acute infectious diseases and febrile diseases；&#xD;
&#xD;
          -  The following circumstances are:&#xD;
&#xD;
               -  Live attenuated vaccine received within 2 months or other vaccine within 2 weeks&#xD;
                  prior to enrollment;&#xD;
&#xD;
               -  Immunoglobin or blood products received within 4 months prior to enrollment;&#xD;
&#xD;
               -  Participation in another trial of a medicinal product, completed less than 30&#xD;
                  days prior to enrollment;&#xD;
&#xD;
               -  Drug abuse, alcoholism, heavy smokers；&#xD;
&#xD;
          -  The following laboratory test abnormalities, except for the results that are assessed&#xD;
             by researchers as being no clinical significance：&#xD;
&#xD;
               -  HIV diagnostic assay positive or suspicious, HIV RNA diagnostic assay positive;&#xD;
&#xD;
               -  Anti-DNA antibody or anti-nuclear antibody positive;&#xD;
&#xD;
               -  Other laboratory test abnormalities;&#xD;
&#xD;
          -  Not complying with study protocol or not obtaining informed consent because of&#xD;
             medical, spiritual, social, occupational, and/or other reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hao Wu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing YouAn Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tong Zhang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing YouAn Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yiming Shao, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NCAIDS, China CDC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Youan Hospital,Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>May 5, 2015</last_update_submitted>
  <last_update_submitted_qc>May 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prophylactic</keyword>
  <keyword>vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccinia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_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/NCT01705223
org study id: X111012202
nct id: NCT01705223
lead sponsor: 
has dmc: Yes
This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by
      recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk
      of HIV infection. In addition, the effect of different intervals of the prime-boost will be
      studied.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence, intensity and relationship to vaccination of local and general adverse events
time frame: 14-day follow-up after DNA vaccine vaccination
measure: Occurrence and relationship to vaccination of any serious AEs (SAEs)
time frame: During the study period (Month 0-20)
measure: Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)
time frame: During the study period (Month 0-20)
measure: test HIV specific T cell response by ELISPOT
time frame: 2wk, 4wk, 14wk, 24wk after rTV vaccination
measure: test HIV specific antibody by ELISA
time frame: 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination
measure: Occurrence, intensity and relationship to vaccination of local and general adverse events
time frame: 28-day follow-up after rTV vaccination
measure: test HIV specific T cell response by ICS
time frame: 4wk, 8wk, 14wk, 48wk after rTV vaccination
measure: HIV neutralizing antibody test
time frame: 4wk, 14wk, 48wk after rTV vaccination
measure: vaccinia virus antibody test
time frame: 2wk, 4wk, 24wk after rTV vaccination
arm group label: group A
arm group type: Experimental
description: DNA vaccine prime at week 0,4,8 and rTV boost at week 16
arm group label: group B
arm group type: Experimental
description: DNA vaccine prime at week 0,4,8 and rTV boost at week 24
arm group label: group C
arm group type: Experimental
description: DNA vaccine prime at week 0,4,8 and rTV boost at week 32
arm group label: group D
arm group type: Experimental
description: DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24
intervention type: Biological
intervention name: DNA vaccine
description: 4mg/dose, three doses at week 0,4,8
arm group label: group A
arm group label: group B
arm group label: group C
intervention type: Biological
intervention name: DNA vaccine prime with the addition of electroporation
description: 4mg/dose, three doses at week 0,4,8
arm group label: group D
intervention type: Biological
intervention name: rTV boost
description: at week 16
arm group label: group A
intervention type: Biological
intervention name: rTV boost
description: at week 24
arm group label: group B
arm group label: group D
intervention type: Biological
intervention name: rTV boost
description: at week 32
arm group label: group C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hao Wu, M.D.
role: Principal Investigator
affiliation: Beijing YouAn Hospital
last name: Tong Zhang, M.D.
role: Principal Investigator
affiliation: Beijing YouAn Hospital
last name: Yiming Shao, Ph.D.
role: Principal Investigator
affiliation: NCAIDS, China CDC
facility: 
country: China
responsible party type: Sponsor
mesh term: Vaccinia
mesh term: Vaccines