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

Summary

Background:

\- Researchers are investigating the use of DNA vaccines to treat various types of cancer by provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal vaccines given to prevent infectious diseases, but they have been less effective than anticipated in humans. To improve the effectiveness of DNA vaccines, researchers are studying alternate delivery methods, such as the investigational Derma Vax(Trademark) injection system that delivers the vaccine into the skin. However, because the Derma Vax(Trademark) system has not been studied in humans, more research is needed to determine whether this new vaccine delivery method is safe and tolerable, particularly in terms of pain levels and skin reactions.

Objectives:

\- To evaluate the safety, effectiveness, and relative pain levels of intradermal electroporation using Derma Vax(Trademark) administered after pretreatment with either a topical cream anesthetic or placebo cream.

Eligibility:

\- Healthy individuals between 18 and 55 years of age.

Design:

* Participants will be screened with a medical history, physical examination, blood and urine tests, and an electrocardiogram.
* Participants will have two different creams applied to their upper arms: one cream will be an anesthetic (lidocaine and prilocaine) and the other will be a placebo lotion. Each arm will receive a different cream.
* Once the cream has taken effect, participants will receive Derma Vax(Trademark) treatment. No actual medication will be given during the injection; participants will evaluate their reaction based on the pressure and needle stick alone.
* Immediately after the treatment, participants will use the Visual Analogue Scale of pain intensity to provide a description of the level of pain experienced during the injection.
* Participants will complete additional questionnaires about pain intensity and will have the injected skin site inspected to determine possible reactions to the injection. They will also be asked their opinions on whether (based on pain levels) a series of Derma Vax(Trademark) treatments would be acceptable for treatment of a serious illness.
* The day after the injection, participants will return for an additional skin assessment of the treated areas.

Conditions

• Intradermal Electroporation

Interventions

DRUG

EMLA Cream

DRUG

Aveeno Daily Moist

DEVICE

Derma Vax

PROCEDURE

Intradermal Electroporation

PROCEDURE

Visual Analogue Scale

PROCEDURE

Present Pain Intensity

PROCEDURE

McGill Pain Questionnaire

PROCEDURE

Skin Assessment

Sponsors & Collaborators

• National Institute on Aging (NIA)

  lead NIH

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-06-25

Primary Completion

2010-05-27

Completion

2010-05-27

Countries

• United States

Study Locations