Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers (ADVAX-EP)
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.
|HIV Infections||Device: TriGrid™ Delivery System Device: conventional intramuscular injection||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of Local and Systemic Reactogenicity Following Serial Administration of ADVAX, a Clade C DNA Vaccine, ADVAX e/g + ADVAX p/N-t, by Ichor TriGrid™ in Vivo Electroporation to HIV-Uninfected, Healthy Volunteers|
- To evaluate the safety of an intramuscular prime and boost injection of the ADVAX DNA-based HIV vaccine via TriGrid™ electroporation at all three dosing levels [ Time Frame: wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56 ]
- • To evaluate the immunogenicity of an intramuscular prime and boost injection of the ADVAX DNA-based HIV vaccine via TriGrid™ electroporation compared to placebo or standard syringe injection at all three dosing levels. [ Time Frame: wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56 ]
|Study Start Date:||September 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: intramuscular injection
administration of an HIV-1 vaccine by conventional intramuscular injection
Device: conventional intramuscular injection
administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection
Experimental: TriGrid Delivery System
electroporation-mediated intramuscular delivery using the TriGridTM device by Ichor Medical Systems, Inc.
Device: TriGrid™ Delivery System
Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.
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 called electroporation.
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 patients' tumors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545987
|United States, New York|
|The Rockefeller University Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||David Ho, M.D.||The Aaron Diamond AIDS Research Center|