A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)

Inclusion Criteria Subjects must have: Normal history and physical exam. Negative for HIV by ELISA within 6 weeks of immunization. CD4 count >= 400 cells/mm3. Normal urinalysis. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: Medical or psychiatric condition or occupational responsibilities that preclude compliance. Active syphilis (volunteers are eligible if serology is documented to be a false positive or due to a remote (> 6 months) treated infection). Active tuberculosis (volunteers with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible). Hepatitis B surface antigenemia. Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. History of anaphylaxis or other serious adverse reactions to vaccines. Prior Medication: Excluded: Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are permitted if received at least 2 weeks prior to first immunization. Experimental agents within the past 30 days. Prior HIV vaccines. Prior Treatment: Excluded: Blood products or immunoglobulin within the past 6 months. Identifiable high-risk behavior for HIV infection, including history of injection drug use within the last 12 months prior to enrollment and higher or intermediate risk sexual behavior.