Back to results

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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TriGrid™ Delivery System

conventional intramuscular injection

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV vaccine, HIV, AIDS, prevention, HIV/AIDS, HIV Preventative Vaccine, HIV Seronegativity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Rockefeller University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

intramuscular injection

TriGrid Delivery System

Arm Description

administration of an HIV-1 vaccine by conventional intramuscular injection

electroporation-mediated intramuscular delivery using the TriGridTM device by Ichor Medical Systems, Inc.

Outcomes

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

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.

Full Information

NCT ID

NCT00545987

First Posted

October 16, 2007

Last Updated

May 4, 2011

Sponsor

Rockefeller University

Collaborators

Aaron Diamond AIDS Research Center, Bill and Melinda Gates Foundation, Ichor Medical Systems Incorporated, International AIDS Vaccine Initiative

1. Study Identification

Unique Protocol Identification Number

NCT00545987

Brief Title

Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rockefeller University

Collaborators

Aaron Diamond AIDS Research Center, Bill and Melinda Gates Foundation, Ichor Medical Systems Incorporated, International AIDS Vaccine Initiative

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV vaccine, HIV, AIDS, prevention, HIV/AIDS, HIV Preventative Vaccine, HIV Seronegativity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intramuscular injection

Arm Type

Active Comparator

Arm Description

administration of an HIV-1 vaccine by conventional intramuscular injection

Arm Title

TriGrid Delivery System

Arm Type

Experimental

Arm Description

electroporation-mediated intramuscular delivery using the TriGridTM device by Ichor Medical Systems, Inc.

Intervention Type

Device

Intervention Name(s)

TriGrid™ Delivery System

Intervention Description

Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.

Intervention Type

Device

Intervention Name(s)

conventional intramuscular injection

Intervention Description

administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Ho, M.D.

Organizational Affiliation

The Aaron Diamond AIDS Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Rockefeller University Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21603651

Citation

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. doi: 10.1371/journal.pone.0019252. Epub 2011 May 16.

Results Reference

derived

Links:

URL

http://www.adarc.org/

Description

The Aaron Diamond AIDS Research Center

Learn more about this trial

Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers

We'll reach out to this number within 24 hrs