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