NCT00545987

Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DEVICE	TriGrid™ Delivery System	Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.
DEVICE	conventional intramuscular injection	administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-10-01
• Completion: 2011-04-01
• First posted: 2007-10-18
• Last updated: 2011-05-05

Locations

1 site across 1 country: United States