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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety