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Safety and Tolerability of the Derma Vax Clinical Intradermal Electroporation System in Healthy Subjects

Phase 1
18 Years
55 Years
Not Enrolling
Intradermal Electroporation

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Trial Information

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.

Inclusion Criteria


- Female and male subjects, age 18 to 55 and in good health as determined by past
medical history, physical examination, vital signs, electrocardiogram, and laboratory

- Body mass index (BMI) must be within the range of 18 to 30 kg/m(2), inclusive

- Vital signs should be within the following ranges at screening and baseline:

1. Oral body temperature between 35.0-37.5 degree C

2. Systolic blood pressure, 85-140 mm Hg

3. Diastolic blood pressure, 50-90 mm Hg

4. Pulse rate, 50 - 100 bpm

- Ability to provide an informed consent.

- Blood tests demonstrating normal physiologic organ functions:

1. Hematological (neutrophils greater than or equal to 1000; hemoglobin greater
than or equal to 12 g/dl (female) and greater than or equal to 14g/dl (male);
platelets > 150,000).

2. Creatinine (Cre < 1.5 times ULN)

3. LFTs (SGOT, SGPT, < 2.5 times ULN)

4. PT and/or PTT < 1.5 times ULN


- Participation in any clinical investigation within 4 weeks prior to dosing or longer
if required by local regulations, and for any other limitation of participation based
on local regulations.

- Significant illness within two weeks prior to dosing.

- History of clinically significant drug allergy or history of atopic allergy (asthma,
urticaria, eczematous dermatitis)

- History of chronic skin disease that might interfere with IDEP application

- Known allergic reactions to adhesive tape

- History of use of chronic or current pain medication (narcotics)

- Sunburn or tattoos at the application sites (both shoulders)

- Subject has a pacemaker or implanted defibrillator

- A past medical history of clinically significant EKG abnormalities or a family
history (grandparents, parents and siblings) of a sudden cardiac death or

- History of drug or alcohol abuse within the 12 months prior to dosing.

- History of noncompliance to medical regimens or unwillingness to comply with the
study protocol

- History of HIV or hepatitis B or C.

- Pregnancy

- Known allergy to local anesthetics such as lidocaine

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Safety & Tolerability of Derma Vax


United States: Federal Government

Study ID:




Start Date:

June 2009

Completion Date:

May 2010

Related Keywords:

  • Intradermal Electroporation
  • Safety and Tolerability
  • Intradermal Electroporation



National Institute of Aging, Harbor Hospital Baltimore, Maryland  21224