Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA.
Mol Ther. 2012 Jan;20(1):214-20. doi: 10.1038/mt.2011.235. Epub 2011 Nov 8.
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™ 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™ electroporation device is safe and well tolerated when administered over the lateral deltoid skin regions in healthy volunteers.
DNA 疫苗具有成本效益和多功能性，尽管在人类中细胞内传递一直具有挑战性。替代传递方式，如电穿孔，已经证明可以提高免疫反应，但会引起疼痛。在这项单中心、双盲、医疗器械试验中，我们评估了 Easy Vax™ 经皮电穿孔系统在健康成年人中的安全性和耐受性，该系统单独（不含 DNA）使用。在两个区域（共 6 个剂量）中，每个区域随机给予 10 名受试者（80%为白人，60%为女性，平均年龄：32.1 岁）三个随机方案剂量。当在前臂区域给予剂量时，有两名受试者报告出现刺痛、灼热和/或刺痛感，但在外侧三角肌区域则没有。随后，其余 8 名受试者的剂量仅限于三角肌区域。耐受性疼痛评分在 11 分疼痛评分量表中从未超过 10 分中的 3 分，在 100 分视觉模拟量表（VAS）中从未超过 10 分中的 12 分，且在随访评估中较低（P < 0.0001），三个剂量方案之间无显著差异。皮肤的自动测量的电特性显示，疼痛强度与皮肤电导率之间无相关性。总之，当在健康志愿者的外侧三角肌皮肤区域使用时，Easy Vax™ 电穿孔设备是安全且耐受良好的。
