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

October 16, 2007
May 4, 2011
September 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00545987 on ClinicalTrials.gov Archive Site
• 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 ]
• 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.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • 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
  • Active Comparator: intramuscular injection
    administration of an HIV-1 vaccine by conventional intramuscular injection
    Intervention: Device: conventional intramuscular injection
  • Experimental: TriGrid Delivery System
    electroporation-mediated intramuscular delivery using the TriGridTM device by Ichor Medical Systems, Inc.
    Intervention: Device: TriGrid™ Delivery System
Vasan S, Hurley A, Schlesinger SJ, Hannaman D, Gardiner DF, Dugin DP, Boente-Carrera M, Vittorino R, Caskey M, Andersen J, Huang Y, Cox JH, Tarragona-Fiol T, Gill DK, Cheeseman H, Clark L, Dally L, Smith C, Schmidt C, Park HH, Kopycinski JT, Gilmour J, Fast P, Bernard R, Ho DD. In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers. PLoS One. 2011;6(5):e19252. Epub 2011 May 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2011
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00545987
DHO-0614
Yes
David Ho, Rockefeller University
Rockefeller University
  • Aaron Diamond AIDS Research Center
  • Bill and Melinda Gates Foundation
  • Ichor Medical Systems Incorporated
  • International AIDS Vaccine Initiative
Principal Investigator: David Ho, M.D. The Aaron Diamond AIDS Research Center
Rockefeller University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP