Immunitor USA Inc., hq 9308 48th avenue, College Park, MD 20740, USA.
Vaccine. 2010 Mar 24;28(15):2763-8. doi: 10.1016/j.vaccine.2010.01.032. Epub 2010 Jan 29.
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.
口服含有猪脂肪组织来源的混合抗原的 V-6 片剂制剂，每日一次，共 13 名志愿者连续服用 3 个月。总胆固醇和 LDL 水平从基线值没有变化；分别为 193.4 与 191.8（p=0.75）和 113.8 与 117.2（p=0.18）。甘油三酯水平从 163 降至 120.5mg/dL，下降了 26.1%（p=0.29）。13 名患者中有 12 名的高密度脂蛋白增加了 25.9%，从 38.6 升至 48.5mg/dL（p=0.000002）。尽管 V6 对体重和体重指数几乎没有影响，即 67.87 与 66.58kg（-1.9%；p=0.46）和 26.25 与 25.75kg/m2（-1.9%；p=0.35），但腰围（-7.6%；p=0.002）、上臂中部（-3.3%；p=0.049）和大腿（-7.6%；p=0.0003）的周长却明显减小。血压的收缩压和舒张压没有变化，分别为 115.6 与 121（p=0.2）和 77.1 与 83（p=0.55）。肝丙氨酸转氨酶和天冬氨酸转氨酶活性没有变化。肌酸酐降低；0.877 与 0.842mg/dL（p=0.02），而血尿素氮略有增加；14.8 与 16.1mg/dL（p=0.03），但仍在正常范围内。空腹血糖水平也在正常范围内，即 94.8 与 98.8（p=0.04）。全血细胞分析除血红蛋白略有下降外（13.25-13.19g/dL；p=0.0004），未发生其他变化，但每个红细胞的平均血红蛋白含量（MCH）从 25.62 增加到 26.42 皮克/细胞（p=0.000003）。平均红细胞体积（MCV）从 78.5 增加到 80.0fl（p=0.00009），但血红蛋白浓度与细胞大小的比值（MCHC）没有变化（p=0.2）。红细胞压积和红细胞计数略有下降，但仍在正常范围内（分别为 40.7-40.2%；p=0.02 和 5.22-5.05 x 106cells/mm3；p=0.002）。血小板数量上升，为 2.471 与 2.921 x 105/mm3（p=0.009）。白细胞计数、白细胞百分比和中性粒细胞百分比不受影响。促炎嗜酸性粒细胞从 4.0%下降到 2.4%（p=0.29）。这些结果表明，V6 是安全的，具有作为抗动脉粥样硬化和超重/肥胖免疫干预的潜力。
