Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis

Conditions
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Atherosclerosis

Intervention / Treatment
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* Biological: atherosclerosis vaccine
* Biological: Placebo pills


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V6 recipients<br>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<br>* Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue<br>|
| Placebo Comparator: Placebo recipients<br>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<br>* Half of the patients will be randomly assigned to receive placebo pill<br>|

What is the study measuring?
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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 |