Safety and Tolerability of the Easy Vax™ Clinical Epidermal Electroporation System in Healthy Adults
Safety and Tolerability of the Easy Vax™ Clinical Epidermal Electroporation System in Healthy Adults
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DOI：
10.1038/mt.2011.235
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发表时间：
2012-01-01
影响因子：
12.4
通讯作者：
King, Alan
中科院分区：
文献类型：
--
作者：
El-Kamary, Samer S.;Billington, Melissa;King, Alan
DNA疫苗具有成本效益和多功能性，尽管细胞内递送对人类来说一直是具有挑战性的。电穿孔等替代给药方式显示了更好的免疫反应，但也很痛苦。在这项单中心、双盲、医疗器械试验中，我们评估了Easy VAX(TM)皮肤电穿孔系统单独(不含DNA)在健康成年人身上的安全性和耐受性。两个地区的10名受试者(白人占80%，女性占60%，平均年龄：32.1岁)分别接受了三种随机方案的剂量(总共六剂)。两名受试者抱怨说，当剂量在前臂区域，而不是外侧三角区时，会出现枪击疼痛、灼热和/或刺痛。其余8名受试者的后续剂量仅限于三角区。耐受性疼痛评分在11分疼痛评定量表中从未超过3分，在视觉模拟评分中从未超过12分，在随访评估中更低(P<；0.0001)，三种给药方案之间没有显著差异。由该设备自动测量的皮肤电属性显示，疼痛强度和皮肤电导之间没有相关性。总之，Easy VAX(TM)电穿孔设备在健康志愿者的三角肌外侧皮肤区域使用是安全和耐受性良好的。
DNA vaccines are cost-effective and versatile, though intracellular delivery has been challenging in humans. Alternative delivery modalities such as electroporation have demonstrated improved immune responses, but are painful. In this single-center, double-blind, medical device trial, we evaluated the safety and tolerability of Easy Vax (TM) dermal electroporation system, alone (without DNA) in healthy adults. Three randomized protocol doses were administered to 10 subjects (80% white, 60% female, mean age: 32.1 years) in each of two areas (total of six doses). Two subjects complained of shooting pain, burning and/or tingling when doses were administered to the forearm region, but not the lateral deltoid regions. Subsequent doses for the remaining eight subjects were restricted to the deltoid regions only. Tolerability pain scores never exceeded 3 of 10 in the 11-Point Pain Rating scale, and 12 of 100 in the Visual Analog Scale (VAS), and lower in follow-up evaluations (P < 0.0001), with no significant difference between the three dosing protocols. Electrical properties of the skin, measured automatically by the device, showed no correlation between pain intensity and skin conductance. In conclusion, the Easy Vax (TM) electroporation device is safe and well tolerated when administered over the lateral deltoid skin regions in healthy volunteers.