<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/NCT03042741</url>
  </required_header>
  <id_info>
    <org_study_id>V6</org_study_id>
    <nct_id>NCT03042741</nct_id>
  </id_info>
  <brief_title>Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity</brief_title>
  <acronym>V6</acronym>
  <official_title>Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immunitor LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Immunitor LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical&#xD;
      trials. It has shown significant improvement in lipid profile in patients with overweight or&#xD;
      obesity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will evaluate daily dose of one V6 pill administered for one month in&#xD;
      placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline&#xD;
      waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes&#xD;
      in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of&#xD;
      waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline&#xD;
      versus post-treatment timepoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 18, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 18, 2019</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Group on experimental drug compared against group receiving placebo in randomized, blinded phase III study to evaluate effect on lipid profile, i.e., LDL, HDL, triglycerides and total cholesterol</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double-blind study in two groups of patients assigned randomly into experimental and placebo arms</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Immunotherapy of atherosclerosis</measure>
    <time_frame>1 month</time_frame>
    <description>Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on anthropomorphic indices of obesity</measure>
    <time_frame>1 month</time_frame>
    <description>Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on hypertension</measure>
    <time_frame>1 month</time_frame>
    <description>The systolic and diastolic blood pressures measured one month apart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on glucose levels</measure>
    <time_frame>1 month</time_frame>
    <description>Changes in fasting glucose levels from baseline to post-treatment time-point</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>V6 recipients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive V6 - oral atherosclerosis vaccine administered once per day for one month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo recipients</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive placebo pills given once per day as a single pill for one month</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>atherosclerosis vaccine</intervention_name>
    <description>Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue</description>
    <arm_group_label>V6 recipients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo pills</intervention_name>
    <description>Half of the patients will be randomly assigned to receive placebo pill</description>
    <arm_group_label>Placebo recipients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Baseline waist diameter over 90 and 80 cm for men and women, respectively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Individuals with clinical symptoms or diseases who in opinion of study investigators&#xD;
             are not eligible to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allen Bain, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Immunitor Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>aldar bourinbayar, PhD, MD/PhD</last_name>
    <phone>3014760930</phone>
    <email>IMMUNITOR@GMAIL.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>galyna kutsyna, MD, MD/PhD</last_name>
    <phone>0380508923222</phone>
    <email>kutsynagalyna@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Immunitor LLC</name>
      <address>
        <city>Ulaanbaatar</city>
        <state>CA</state>
        <zip>13838</zip>
        <country>Mongolia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>aldar bourinbaiar</last_name>
      <phone>3014760930</phone>
      <email>aldar@immunitor.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Mongolia</country>
  </location_countries>
  <reference>
    <citation>Bourinbaiar AS, Jirathitikal V. Effect of oral immunization with pooled antigens derived from adipose tissue on atherosclerosis and obesity indices. Vaccine. 2010 Mar 24;28(15):2763-8. doi: 10.1016/j.vaccine.2010.01.032. Epub 2010 Jan 29.</citation>
    <PMID>20117273</PMID>
  </reference>
  <reference>
    <citation>Bourinbaiar AS, Jirathitikal V. Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study. Lipids Health Dis. 2010 Feb 2;9:14. doi: 10.1186/1476-511X-9-14.</citation>
    <PMID>20122177</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>April 14, 2019</last_update_submitted>
  <last_update_submitted_qc>April 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be shared without identification of participants</ipd_description>
  </patient_data>
  <!-- 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/NCT03042741
org study id: V6
nct id: NCT03042741
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical
      trials. It has shown significant improvement in lipid profile in patients with overweight or
      obesity
The proposed study will evaluate daily dose of one V6 pill administered for one month in
      placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline
      waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes
      in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of
      waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline
      versus post-treatment timepoint.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group on experimental drug compared against group receiving placebo in randomized, blinded phase III study to evaluate effect on lipid profile, i.e., LDL, HDL, triglycerides and total cholesterol
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double-blind study in two groups of patients assigned randomly into experimental and placebo arms
measure: Immunotherapy of atherosclerosis
time frame: 1 month
description: Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol
measure: Effect on anthropomorphic indices of obesity
time frame: 1 month
description: Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements
measure: Effect on hypertension
time frame: 1 month
description: The systolic and diastolic blood pressures measured one month apart
measure: Effect on glucose levels
time frame: 1 month
description: Changes in fasting glucose levels from baseline to post-treatment time-point
arm group label: V6 recipients
arm group type: Experimental
description: Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive V6 - oral atherosclerosis vaccine administered once per day for one month
arm group label: Placebo recipients
arm group type: Placebo Comparator
description: Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive placebo pills given once per day as a single pill for one month
intervention type: Biological
intervention name: atherosclerosis vaccine
description: Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
arm group label: V6 recipients
intervention type: Biological
intervention name: Placebo pills
description: Half of the patients will be randomly assigned to receive placebo pill
arm group label: Placebo recipients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Allen Bain, PhD
role: Study Chair
affiliation: Immunitor Inc.
last name: aldar bourinbayar, PhD, MD/PhD
phone: 3014760930
email: IMMUNITOR@GMAIL.COM
last name: galyna kutsyna, MD, MD/PhD
phone: 0380508923222
email: kutsynagalyna@yahoo.com
facility: 
status: Recruiting
contact: 
country: Mongolia
citation: Bourinbaiar AS, Jirathitikal V. Effect of oral immunization with pooled antigens derived from adipose tissue on atherosclerosis and obesity indices. Vaccine. 2010 Mar 24;28(15):2763-8. doi: 10.1016/j.vaccine.2010.01.032. Epub 2010 Jan 29.
PMID: 20117273
citation: Bourinbaiar AS, Jirathitikal V. Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study. Lipids Health Dis. 2010 Feb 2;9:14. doi: 10.1186/1476-511X-9-14.
PMID: 20122177
responsible party type: Sponsor
mesh term: Atherosclerosis
sharing ipd: Undecided
ipd description: Data will be shared without identification of participants