Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity
V6
Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis
1 other identifier
interventional
300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2017
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2019
CompletedApril 16, 2019
August 1, 2018
2.9 years
February 1, 2017
April 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Immunotherapy of atherosclerosis
Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol
1 month
Secondary Outcomes (3)
Effect on anthropomorphic indices of obesity
1 month
Effect on hypertension
1 month
Effect on glucose levels
1 month
Study Arms (2)
V6 recipients
EXPERIMENTALArm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive V6 - oral atherosclerosis vaccine administered once per day for one month
Placebo recipients
PLACEBO COMPARATORArm 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
Interventions
Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
Half of the patients will be randomly assigned to receive placebo pill
Eligibility Criteria
You may qualify if:
- Baseline waist diameter over 90 and 80 cm for men and women, respectively
You may not qualify if:
- Pregnant and lactating women
- Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Immunitor LLC
Ulaanbaatar, CA, 13838, Mongolia
Related 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.
PMID: 20117273BACKGROUNDBourinbaiar 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: 20122177BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Allen Bain, PhD
Immunitor Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind study in two groups of patients assigned randomly into experimental and placebo arms
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2017
First Posted
February 3, 2017
Study Start
February 1, 2017
Primary Completion
December 18, 2019
Study Completion
December 18, 2019
Last Updated
April 16, 2019
Record last verified: 2018-08