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Our Vaccine Trial Many different possible HIV vaccines are currently being developed and tested. The ADVAX vaccine which will be used in this trial 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 called electroporation. Electroporation uses a device that injects substances into the 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 patients’ tumors. 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 an individual and their immune system. You CANNOT contract HIV infection from the vaccine being tested. |
