Safety and Tolerability of the Derma Vax Electroporation System

目的：我们的主要目标是：评估在用EMLA乳膏作为局部麻醉剂或用安慰剂预处理后使用Derma Vax进行皮内电穿孔（IDEP）的安全性和耐受性，并确定应用于电穿孔部位的EMLA乳膏是否显著减轻与IDEP程序相关的疼痛。我们的次要目标是：使用视觉模拟量表确定IDEP的疼痛感觉的程度;使用麦吉尔疼痛量表确定IDEP期间疼痛感觉的质量;确定IDEP后疼痛等级和皮肤刺激的时间进程，并确定使用和不使用EMLA乳膏以及参与者之间皮肤电阻的变化。 实验设计和方法：本研究将招募12名健康男性或女性。这是一项使用医疗器械的随机、双盲、安慰剂对照研究。每例受试者将以盲态随机方式接受EMLA乳膏或对照乳膏，置于每个三角肌区域的电穿孔部位。随后对每个预处理三角肌区域进行IDEP给药。 医学相关性和预期结果：DNA疫苗是治疗传染病和癌症的一种有希望的方法。用于诱导细胞和体液免疫应答的理想递送方法尚未确定。本研究的信息对于将来在治疗性DNA疫苗研究中使用Derma Vax的研究是必要的。Derma Vax的独特之处在于其提供一系列电脉冲的特性，这些电脉冲可以激发皮肤真皮层中抗原呈递细胞的DNA摄取。我们预计，使用Derma Vax进行皮内电穿孔（IDEP）的应用将具有良好的耐受性，与安慰剂相比，使用EMLA乳膏将减轻疼痛。

Objectives: Our primary objectives are: to assess safety and tolerability of Intradermal electroporation (IDEP) using Derma Vax administered after pretreatment with either EMLA cream as topical anesthetic or with placebo and to determine if the EMLA cream applied to the electroporation site significantly decreases pain associated with the IDEP procedure. Our secondary objectives are: to determine the magnitude of pain perception of IDEP using a Visual Analog Scale; to determine the quality of pain perception during IDEP using the McGill pain scale; to determine the time course after IDEP of pain rating and skin irritation and to determine variations in skin resistance with and without EMLA cream and between participants. Experimental Design and Methods: Twelve healthy men or women will be recruited for this study. This is a randomized double-blind, placebo-controlled study with a medical device. Each subject will receive EMLA cream or control cream placed on the electroporation site on each deltoid area in a blinded randomized manner. This will be followed by IDEP administration to each pre-treated deltoid area. Medical Relevance and Expected Outcome: DNA vaccines are a promising treatment for infectious diseases and cancer. The ideal delivery method for induction of cellular and humoral immune responses has not been defined. Information from this study is necessary for future studies using Derma Vax in therapeutic DNA vaccine studies. Derma Vax is unique in its proprieties of delivering a series of electric pulses that provoke DNA uptake by antigen presenting cells that reside in the dermal layer of the skin. We expect that the application of Intradermal Electroporation (IDEP) using Derma Vax will be well tolerated and the use of EMLA cream will decrease the pain compared to placebo.