A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects

Inclusion Criteria Subjects must have: Normal history and physical exam. HIV negativity by ELISA within 8 weeks of immunization. CD4 count >= 400 cells/mm3. Normal urinalysis. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: Positive hepatitis B surface antigen. Medical or psychiatric condition or occupational responsibilities that preclude study compliance. Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (> 6 months) treated infection are eligible. Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, or autoimmune disease. History of anaphylaxis or other serious reactions to vaccines. Prior Medication: Excluded: History of immunosuppressive medications. Live attenuated vaccines within 60 days prior to study entry (NOTE: Medically indicated subunit or killed vaccines, e.g., influenza or pneumococcal, are not exclusionary, but should not be given within 2 weeks of HIV immunization). Experimental agents within 30 days prior to study entry. Prior HIV vaccines. Prior Treatment: Excluded: Blood products or immunoglobulin within the past 6 months. Identifiable higher risk behavior for HIV infection, including the following: History of injection drug use within the past 12 months. Higher risk sexual behavior as defined by the AVEG.