Safety and Tolerability of the Derma Vax Clinical Intradermal Electroporation System in Healthy Subjects
Our primary objectives are: to assess safety and tolerability of Intradermal electroporation
(IDEP) using Derma Vax(Trademark) administered after pretreatment with either
EMLA(Registered Trademark) cream as topical anesthetic or with placebo and to determine if
the EMLA(Registered Trademark) 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; to determine the quality of pain
perception during IDEP using a Visual Analog Scale and 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(Registered Trademark) 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(Registered Trademark) 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(Trademark) in
therapeutic DNA vaccine studies. Derma Vax(Trademark) 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(Trademark) will be well tolerated and the use of
EMLA(Registered Trademark) cream will decrease the pain compared to placebo.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Safety & Tolerability of Derma Vax
United States: Federal Government
|National Institute of Aging, Harbor Hospital||Baltimore, Maryland 21224|