search
Back to results

Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity (V6)

Primary Purpose

Atherosclerosis

Status
Unknown status
Phase
Phase 3
Locations
Mongolia
Study Type
Interventional
Intervention
atherosclerosis vaccine
Placebo pills
Sponsored by
Immunitor LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Baseline waist diameter over 90 and 80 cm for men and women, respectively

Exclusion Criteria:

  • Pregnant and lactating women
  • Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate

Sites / Locations

  • Immunitor LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V6 recipients

Placebo recipients

Arm 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 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

Outcomes

Primary Outcome Measures

Immunotherapy of atherosclerosis
Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol

Secondary Outcome Measures

Effect on anthropomorphic indices of obesity
Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements
Effect on hypertension
The systolic and diastolic blood pressures measured one month apart
Effect on glucose levels
Changes in fasting glucose levels from baseline to post-treatment time-point

Full Information

First Posted
February 1, 2017
Last Updated
April 14, 2019
Sponsor
Immunitor LLC
Collaborators
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
search

1. Study Identification

Unique Protocol Identification Number
NCT03042741
Brief Title
Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity
Acronym
V6
Official Title
Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 18, 2019 (Anticipated)
Study Completion Date
December 18, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunitor LLC
Collaborators
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind study in two groups of patients assigned randomly into experimental and placebo arms
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V6 recipients
Arm Type
Experimental
Arm 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 Title
Placebo recipients
Arm Type
Placebo Comparator
Arm 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(s)
atherosclerosis vaccine
Intervention Description
Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
Intervention Type
Biological
Intervention Name(s)
Placebo pills
Intervention Description
Half of the patients will be randomly assigned to receive placebo pill
Primary Outcome Measure Information:
Title
Immunotherapy of atherosclerosis
Description
Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Effect on anthropomorphic indices of obesity
Description
Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements
Time Frame
1 month
Title
Effect on hypertension
Description
The systolic and diastolic blood pressures measured one month apart
Time Frame
1 month
Title
Effect on glucose levels
Description
Changes in fasting glucose levels from baseline to post-treatment time-point
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Baseline waist diameter over 90 and 80 cm for men and women, respectively Exclusion Criteria: Pregnant and lactating women Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
aldar bourinbayar, PhD, MD/PhD
Phone
3014760930
Email
IMMUNITOR@GMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
galyna kutsyna, MD, MD/PhD
Phone
0380508923222
Email
kutsynagalyna@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Bain, PhD
Organizational Affiliation
Immunitor Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Immunitor LLC
City
Ulaanbaatar
State/Province
CA
ZIP/Postal Code
13838
Country
Mongolia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aldar bourinbaiar
Phone
3014760930
Email
aldar@immunitor.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared without identification of participants
Citations:
PubMed Identifier
20117273
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.
Results Reference
background
PubMed Identifier
20122177
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.
Results Reference
background

Learn more about this trial

Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity

We'll reach out to this number within 24 hrs