HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly

The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.

Inclusion Criteria

Volunteers may be eligible for this study if they:

• Are legal US residents.
• Are healthy adults from 18 to 55 years of age.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

• Are HIV-positive.
• Are at highest risk for HIV infection.
• Are pregnant or breast-feeding.
• Are allergic to eggs or neomycin.
• Use certain prescription medications.