Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity

Atherosclerosis Clinical Trial

— V6  

Official title:

Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03042741
• Other study ID #: V6
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2017
• Est. completion date: December 18, 2019

Study information

• Verified date: August 2018
• Source: Immunitor LLC
• Contact: aldar bourinbayar, PhD, MD/PhD
• Phone: 3014760930
• Email: IMMUNITOR[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Biological:
• atherosclerosis vaccine
Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
• Placebo pills
Half of the patients will be randomly assigned to receive placebo pill

Locations

Country	Name	City	State
Mongolia	Immunitor LLC	Ulaanbaatar	CA

Sponsors (2)

Lead Sponsor	Collaborator
Immunitor LLC	Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Country where clinical trial is conducted

Mongolia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunotherapy of atherosclerosis	Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol	1 month
Secondary	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
Secondary	Effect on hypertension	The systolic and diastolic blood pressures measured one month apart	1 month
Secondary	Effect on glucose levels	Changes in fasting glucose levels from baseline to post-treatment time-point	1 month