Department of Psychiatry
Penn Behavioral Health

HIV/AIDS Prevention Research Division

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HVTN 505


About the study

PhillyVaxThe HIV Vaccine Trials Network (HVTN) and the University of Pennsylvania are conducting a research study (an experiment) as part of an effort to find a vaccine for HIV. HIV is the virus that causes AIDS. Vaccines are given to teach the body to prevent infection or fight disease.

Some vaccines can prevent a disease entirely. Other vaccines can help the body prepare to fight a disease so that a person doesn't get as sick. That is the vaccine idea being tested in this study. About 1,350 people will take part in this study at multiple sites. We anticipate enrolling about 118 participants at the University of Pennsylvania. If you join this study, you will be in the study for about 5 years.

We are doing this study to answer these questions:

Can the study vaccines reduce the level of HIV in the blood of people who become infected with HIV?

Are the study vaccines safe to give to people?

The study vaccines are not made from live HIV or from HIV-infected cells. They do not contain live or killed HIV. It is impossible for the study vaccines to give you HIV. Also, they cannot cause you to give HIV to someone else.

The vaccines are called VRC-HIVDNA016-00-VP (DNA vaccine) and VRC-HIVADV014-00-VP (recombinant adenoviral vector vaccine). For short, we'll call them the DNA and rAd5 vaccines or the "study vaccines." They are experimental HIV vaccines. The US Food and Drug Administration (FDA) has not approved them for any other use.

Both of the study vaccines contain pieces of man-made DNA. DNA is a natural substance found in all living things, including people and some viruses. DNA instructs cells to make proteins. When these study vaccines are injected, the DNA will tell the body to make small amounts of proteins that look like the ones found in HIV without using any real HIV in the vaccine. This study will see if your body recognizes the proteins. If it does, it might help your body fight against HIV if you ever become infected.

The study vaccines have been given to people before. The DNA and rAd5 vaccines have been given to hundreds of people in earlier studies without serious side effects.

If you choose to come in to the clinic to explore this study, you will go through a process called screening. This involves a physical exam, HIV test and health history. We will review the screening results with you. The screening results may show you are not eligible to join the study.

Not everyone in this study will get the study vaccines. Some people will get placebos. Placebos are inactive solutions that do not contain the vaccines. We will compare the results from the people who got the study vaccines with results from people who got the placebos. We will give you the study vaccines or placebos by injection into the upper arm.

If you are interested in learning more about this study, please contact us at 1-866-HIV-PENN.

Also, visit HopeTakesAction.org.

 

Protocol Title:

HVTN 505: A Phase 2, randomized, placebo-controlled trial to evaluate the safety and effect on post-HIV acquisition viremia of a multiclade HIV-1 DNA plasmid vaccine followed by a multiclade HIV-1 recombinant adenoviral vector vaccine in HIV-uninfected, adenovirus type 5 neutralizing antibody negative, circumcised men (Protocol version 1.0, February 25, 2009)

Short title: VRC DNA prime/rAd5 boost HIV vaccines in Ad5 seronegative men


Principal Investigator:

Ian Frank, MD
3535 Market St., 4th floor, Ste 4000
215-662-7419


Co-Investigators:

David S. Metzger, PhD
3535 Market St., 4th floor, Ste 4000
215-746-7346

Debora Dunbar, MSN, CRNP
3535 Market St., 4th floor, Ste 4000
215-746-3713

 

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