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

Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis

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

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis
• Intervention / Treatment: Biological: atherosclerosis vaccine; Biological: Placebo pills

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: aldar bourinbayar, PhD, MD/PhD; Phone Number: 3014760930; Email: IMMUNITOR@GMAIL.COM
• Study Contact Backup: Name: galyna kutsyna, MD, MD/PhD; Phone Number: 0380508923222; Email: kutsynagalyna@yahoo.com

Study Locations

• Mongolia
  • CA
    • Ulaanbaatar, CA, Mongolia, 13838
      • Recruiting
      • Immunitor LLC
      • Contact: aldar bourinbaiar; Phone Number: 3014760930; Email: aldar@immunitor.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V6 recipients; 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	Biological: atherosclerosis vaccine; Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
Placebo Comparator: Placebo recipients; 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	Biological: Placebo pills; Half of the patients will be randomly assigned to receive placebo pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunotherapy of atherosclerosis	Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on anthropomorphic indices of obesity	Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements	1 month
Effect on hypertension	The systolic and diastolic blood pressures measured one month apart	1 month
Effect on glucose levels	Changes in fasting glucose levels from baseline to post-treatment time-point	1 month

Collaborators and Investigators

• Sponsor: Immunitor LLC
• Collaborators: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
• Investigators: Study Chair: Allen Bain, PhD, Immunitor Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 18, 2019
• Study Completion (Anticipated): December 18, 2019

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 14, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: v6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared without identification of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No