Trial record 7 of 24 for:    " October 10, 2007":" November 09, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers (ADVAX-EP)

This study has been completed.
Sponsor:
Collaborators:
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
First received: October 16, 2007
Last updated: May 4, 2011
Last verified: May 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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
Study Completion Date: April 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  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 participation
  4. Hepatitis B; hepatitis C
  5. Syphilis
  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 years
  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 40 mm
  14. In the opinion of the investigator, unlikely to comply with protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Rockefeller University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Ho, Rockefeller University
ClinicalTrials.gov Identifier: NCT00545987     History of Changes
Other Study ID Numbers: DHO-0614
Study First Received: October 16, 2007
Last Updated: May 4, 2011
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014