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| Name | Class |
|---|---|
| Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V6 recipients | Experimental | 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 |
|
| Placebo recipients | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atherosclerosis vaccine | Biological | Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunotherapy of atherosclerosis | Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol | 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| aldar bourinbayar, PhD, MD/PhD | Contact | 3014760930 | IMMUNITOR@GMAIL.COM | |
| galyna kutsyna, MD, MD/PhD | Contact | 0380508923222 | kutsynagalyna@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Allen Bain, PhD | Immunitor Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Immunitor LLC | Recruiting | Ulaanbaatar | CA | 13838 | Mongolia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20117273 | Background | 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. | |
| 20122177 | Background | 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. |
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Data will be shared without identification of participants
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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
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Double-blind study in two groups of patients assigned randomly into experimental and placebo arms
| Placebo pills | Biological | Half of the patients will be randomly assigned to receive placebo pill |
|
| 1 month |
| Effect on glucose levels | Changes in fasting glucose levels from baseline to post-treatment time-point | 1 month |