This study will test the safety of a HIV DNA vaccine after it is injected into your muscle
using an electroporation device (TriGrid™ Delivery System made by Ichor Medical Systems),
and will test the ability of the vaccine to help your body make antibodies and T-Cells.
In this study, we would like to learn about the effects that electroporation of the HIV DNA
has on you and your immune system.
Over 40 million people worldwide are currently infected with HIV, the virus that causes AIDS
(Acquired Immune Deficiency Syndrome). The number of new cases continues to rise at an
alarming rate. Other infectious diseases, such as smallpox or poliomyelitis, have been
controlled, or even eliminated, by vaccination programs. Many experts believe that an HIV
vaccine offers the best hope for controlling the epidemic.
Many different possible HIV vaccines are currently being developed and tested.
The ADVAX vaccine which you will receive is one vaccine that has been tested. To date, one
to three doses of the ADVAX vaccine have been given to 45 individuals in a study that took
place between December 2003 and October 2005 at the Rockefeller University and the
University of Rochester and it appears to be safe. The difference between this ADVAX study
and the previous one is that you will only receive two doses of the vaccine or placebo by
either standard intramuscular injection or by "electroporation."
This study is part of a broader research effort to see if changes in the way vaccines are
given can make vaccines more effective.
The results of other studies suggest that using regular needles may not be the most potent
way to inject this type of vaccine. This is why we are studying a new method of injection
Electroporation uses a device that injects substances into muscle along with small amounts
of electricity. This device has been used to a limited extent in human subjects and has been
shown to be more effective than regular needles and safe when tested in animals. Devices
similar to this have been used in many studies to deliver chemotherapy directly into
1. Healthy Men and Women
2. Ages 18 to 60
3. Not considered to be at high risk to acquire HIV infection.
1. Confirmed HIV-1 or HIV-2 infection
2. Any clinically significant abnormality on history or examination
3. Any clinically significant acute or chronic medical condition requiring care of a
physician (e.g., diabetes, coronary artery disease, rheumatologic illness,
malignancy, substance abuse) that in the opinion of the investigator would preclude
4. Hepatitis B; hepatitis C
6. If female, pregnant, planning a pregnancy during the trial period, or breastfeeding
7. Receipt of a live attenuated vaccine (other than influenza) within 30 days or other
vaccine within 14 days of ADVAX vaccination
8. Receipt of blood transfusion or blood products 6 months prior to vaccination
9. Participation in another clinical study of an investigational product currently or
within past 3 months, or expected participation while enrolled in this study
10. History of severe local or systemic reactogenicity to vaccination or history of
severe allergic reactions
11. Major psychiatric illness including any history of schizophrenia or severe psychosis,
bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3
12. Any electronic stimulation device, such as cardiac demand pacemakers, automatic
implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
13. Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue
for all eligible injection sites (deltoid muscles with intact lymph drainage) exceeds
14. In the opinion of the investigator, unlikely to comply with protocol