title: Safety and tolerability of the Easy Vax™ clinical epidermal electroporation system in healthy adults.
abstract: 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.
authors: Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. selkamar@epi.umaryland.edu
authors: Samer S
authors: SS
authors: El-Kamary
authors: Melissa
authors: M
authors: Billington
authors: Stephen
authors: S
authors: Deitz
authors: Elaina
authors: E
authors: Colby
authors: Howard
authors: H
authors: Rhinehart
authors: Yukun
authors: Y
authors: Wu
authors: William
authors: W
authors: Blackwelder
authors: Robert
authors: R
authors: Edelman
authors: Albert
authors: A
authors: Lee
authors: Alan
authors: A
authors: King
mesh_terms: D000328:Adult; D018274:Electroporation / Q000295:instrumentation* / Q000379:methods*; D004817:Epidermis; D005260:Female; D005500:Follow-Up Studies; D018014:Gene Transfer Techniques; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement