Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00545987

Run by

Rockefeller University

People needed

40

Starts

2007-09-01

Expected to finish

2011-04-01

Last updated by the study team

2011-05-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• The Rockefeller University Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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