Modulation of the inflammatory response through vaccination has shown promise in animal models of atherogenesis and obesity-main risk factors for cardiovascular diseases. Tableted preparation, V-6, containing pooled antigens derived from pig adipose tissue was administered per os daily to 13 volunteers for 3 months. Total cholesterol and LDL levels have not changed from the baseline value; 193.4 vs 191.8 (p=0.75) and 113.8 vs 117.2 (p=0.18), respectively. Triglyceride levels declined by 26.1% from 163 to 120.5mg/dL (p=0.29). HDL increased by 25.9% from 38.6 to 48.5mg/dL (p=0.000002) in 12 out 13 patients. Despite negligible effect of V6 on weight and body mass index, i.e., 67.87 vs 66.58 kg (-1.9%; p=0.46) and 26.25 vs 25.75 kg/m(2) (-1.9%; p=0.35), statistically significant reduction in waist (-7.6%; p=0.002), mid-arm (-3.3%; p=0.049), and thigh (-7.6%; p=0.0003) circumferences were observed. Blood pressure systolic and diastolic values were not affected, i.e., 115.6 vs 121 (p=0.2) and 77.1 vs 83 (p=0.55). No changes were observed in liver ALT and AST enzymes. Creatinine decreased; 0.877 vs 0.842 mg/dL (p=0.02), while BUN has shown slight increase; 14.8 vs 16.1mg/dL (p=0.03) but within normal range. Fasting blood sugar levels were also within normal range, i.e., 94.8 vs 98.8 (p=0.04). Complete blood cell analysis has not revealed any change except slight decrease in hemoglobin 13.25-13.19 g/dL (p=0.0004), but its amount per red blood cell (MCH) increased from 25.62 up to 26.42 picograms/cell (p=0.000003). The average red blood cell size (MCV) increased from 78.5 to 80.0 fl (p=0.00009) but hemoglobin concentration relative to size of the cell (MCHC) has not changed (p=0.2). Hematocrit and red blood cells count decreased slightly, but within normal range 40.7-40.2% (p=0.02) and 5.22-5.05 x 10(6)cells/mm(3) (p=0.002). The number of platelets moved upward, 2.471 vs 2.921 x 10(5)per mm(3) (p=0.009). The white blood cells count and percent of leukocytes and neutrophils were not affected. Pro-inflammatory eosinophils declined from 4.0% down to 2.4% (p=0.29). These results show that V6 is safe and holds a promise as an anti-atherogenic and overweight/obesity immune intervention.
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