SAFETY TRIAL OF TWO HIV VACCINE STRATEGIES IN HIV-NEGATIVE VOLUNTEERS

(HIVNET Protocol 014)

WHAT DO WE HOPE TO LEARN FROM THIS STUDY?

This study is designed to tell us whether the two types of HIV vaccine are safe, and whether the volunteers who receive the vaccines produce an immune system response that may prevent infection. Participants in the study will come from high-risk populations for whom HIV vaccines are intended.

WHO IS PARTICIPATING IN THE STUDY?

255 healthy, HIV-1 uninfected, adult volunteers (men and women) who are at higher-than-average risk of HIV infection.  

• Denver Department of Public Health, Denver, CO
• Fenway Community Health Center,
• Boston, MA
• Howard Brown Health Center,
• Chicago, IL
• New York Blood Center, New York, NY
• New York University Medical Center,
• New York, NY
• San Francisco AIDS Office/Public Health Foundation Enterprises, Inc.,
• San Francisco, CA
• University of Pennsylvania,
• Philadelphia, PA
• University of Washington, Seattle, WA

This vaccine strategy involves giving two injections at each vaccination visit. One injection, called SF-2 rgp120, contains a synthetic version of a substance found on the surface of the HIV particle. The other, called ALVAC-HIV vCP205, contains a canarypox virus that has been modified to contain some HIV genetic information. (Canarypox is a virus that causes disease only in canaries, and it cannot cause disease in humans. However, it will cause an immune response.) It is hoped that this strategy will activate two parts of the immune system, antibodies and killer cells, that together will be effective in fighting off HIV. 

This study will not tell us whether the vaccines will actually prevent disease - that will require a much larger and longer study. This study is designed to tell us whether the vaccines are safe, and whether the volunteers who receive the vaccines produce an immune system response that could be expected to prevent infection. We will also be able to see what procedures work best and should be used for future large trials, and we will be able to assess the impact of participation in a vaccine trial on the volunteer participants. 

Volunteers are screened to make sure they are eligible to be in the study, and are then assigned at random to one of three treatment groups. Each participant will receive two injections simultaneously at separate injection sites (e.g., one in each arm). The three groups are:

Three more injections are given 1 month, 3 months, and 6 months after the first injections. Follow-up will then continue with safety evaluations accompanied by risk reduction counseling at 9, 12, 18, and 24 months after the last injection, with long-term check-ups and months 36 and 48. Measurements of the immune system's response to the vaccine will be done two weeks after the third and fourth injections.