Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers

HIV Infections Clinical Trial

— ADVAX-EP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545987
• Other study ID #: DHO-0614
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2007
• Last updated: May 4, 2011
• Start date: September 2007
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United States	The Rockefeller University Hospital	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Rockefeller University	Aaron Diamond AIDS Research Center, Bill and Melinda Gates Foundation, Ichor Medical Systems Incorporated, International AIDS Vaccine Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56	Yes
Secondary	• 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.		wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56	No

External Links

•   The Aaron Diamond AIDS Research Center