A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals

Inclusion Criteria Subjects must have: Normal history and physical exam. Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen). No history of smallpox (vaccinia) vaccination. Normal urinalysis. Absolute CD4 count = or > 500 cells/mm3. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: Hepatitis B surface antigenemia. Medical or psychiatric condition that precludes compliance with the protocol. Subjects with the following prior conditions are excluded: History of immunodeficiency or chronic illness. Eczema within the past year. Prior Medication: Excluded: Prior experimental HIV vaccine. Prior smallpox vaccine. Immunoglobulin administration within 2 months prior to enrollment. Any experimental agent within 2 months prior to enrollment. History of use of immunosuppressive medications. Prior Treatment: Excluded: Blood or blood product transfusion within the past 6 months. 1. Current high risk for HIV transmission (persons previously at high risk for HIV transmission can be enrolled provided they have a negative HIV screening and no high-risk behavior has been practiced within the last 6 months). Household contact with anyone who is pregnant, has eczema, is less than 12 months of age, or has immunodeficiency disease or is using immunosuppressive medications.