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

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). History of smallpox vaccination more than 5 years prior to enrollment. Normal urinalysis. Absolute CD4 count = or > 500 cells/mm3. Prior Medication: Required: Vaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: Household contacts who are pregnant, < 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications. Hepatitis B surface antigenemia. Medical or psychiatric condition or occupational responsibilities that preclude compliance. 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. Immunoglobulin administration or use of experimental agent within the past 2 months. History of immunosuppressive medications. Prior Treatment: Excluded: Blood or blood product transfusion within the previous 6 months.