Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers - Full Text View

Sponsors and Collaborators:	Rockefeller University Aaron Diamond AIDS Research Center Bill and Melinda Gates Foundation Ichor Medical Systems Incorporated International AIDS Vaccine Initiative
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00545987

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Device: TriGrid™ Delivery System Device: conventional intramuscular injection	Phase I

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
intramuscular injection: Active Comparator 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
TriGrid Delivery System: Experimental 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.

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 inanimals. Devices similar to this have been used in many studies to deliver chemotherapy directly into patients' tumors.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Men and Women
Ages 18 to 60
Not considered to be at high risk to acquire HIV infection.

Exclusion Criteria:

Confirmed HIV-1 or HIV-2 infection
Any clinically significant abnormality on history or examination
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 participation
Hepatitis B; hepatitis C
Syphilis
If female, pregnant, planning a pregnancy during the trial period, or breastfeeding
Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of ADVAX vaccination
Receipt of blood transfusion or blood products 6 months prior to vaccination
Participation in another clinical study of an investigational product currently or within past 3 months, or expected participation while enrolled in this study
History of severe local or systemic reactogenicity to vaccination or history of severe allergic reactions
Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years
Any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
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 40 mm
In the opinion of the investigator, unlikely to comply with protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545987

Locations

United States, New York
The Rockefeller University Hospital
New York, New York, United States, 10021

Sponsors and Collaborators

Rockefeller University

Aaron Diamond AIDS Research Center

Bill and Melinda Gates Foundation

Ichor Medical Systems Incorporated

International AIDS Vaccine Initiative

Investigators

Principal Investigator:

David Ho, M.D.

The Aaron Diamond AIDS Research Center

More Information

The Rockefeller University Hospital This link exits the ClinicalTrials.gov site

The Aaron Diamond AIDS Research Center This link exits the ClinicalTrials.gov site

Responsible Party:	Rockefeller University ( David Ho )
Study ID Numbers:	DHO-0614-0707
Study First Received:	October 16, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00545987
Health Authority:	United States: Food and Drug Administration

Keywords provided by Rockefeller University:

HIV vaccine
HIV
AIDS
prevention

HIV/AIDS
HIV Preventative Vaccine
HIV Seronegativity

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009