Effect of oral immunization with pooled antigens derived from adipose tissue on atherosclerosis and obesity indices

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 120.5 mg/dL (p = 0.29). HDL increased by 25.9% from 38.6 to 48.5 mg/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/m2 (−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 16.1 mg/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 × 106 cells/mm3 (p = 0.002). The number of platelets moved upward, 2.471 vs 2.921 × 105 per mm3 (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.