A Phase I Randomized, Double-Blind, Placebo-Controlled Study of a Multi-Antigen DNA Vaccine Prime Delivered by In Vivo Electroporation, rVSV Booster Vaccine in HIV-Infected Patients Who Began Antiretroviral Therapy During Acute/Early Infection
The purpose of this study is to see how well people with HIV tolerate “therapeutic vaccination.” Therapeutic vaccination means giving a vaccine to TREAT an infection that someone already has. Normally, we give vaccines to PREVENT a person from getting infections (for example, there are vaccines to prevent the flu and the measles).
We also want to see how levels of HIV; CD4 cells (the “good” immune cells that are damaged by HIV); and other measures of HIV infection change after a person receives this vaccination. We plan to show this by stopping cART after some people have been given therapeutic vaccination and others have been given a placebo (a salt water-like solution that should have no effect), for comparison.
Therapeutic vaccination in this study is produced by Profectus BioSciences and includes two different investigational vaccines against HIV (HIV-MAG pDNA and VSV HIV gag). The HIV-MAG pDNA and adjuvant will be given by an investigational device to inject the vaccines into the muscle in your arm. This injection method is called electroporation (EP) and is designed to improve how well your body absorbs some vaccines.
The study vaccines, adjuvant, and EP injection device have not been approved by the Food and Drug Administration (FDA); they will be used in the current study with permission from the FDA for experimental use. That means we don’t know whether they are safe to use in people, or whether they will work to treat your HIV infection.
A total of 30 people, 18 to 65 years of age, with HIV are expected to be enrolled in this study. To be in the study, you must be willing to stop your HIV treatment for about 16 weeks during the study period and, if you are sexually active, you and your partner must agree to take steps to help reduce the chance of passing on the HIV infection, or of pregnancy. Your study participation time is expected to be about 26 months.
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Last Updated July 08, 2013