Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)

Inclusion Criteria

• Volunteers must be healthy adults without high-risk behavior for HIV-1 infection and with history of smallpox vaccination more than 5 years prior to enrollment.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Identifiable high-risk behavior for HIV infection including active intravenous drug use and multiple sexual partners or sexual contact with high-risk partners within the past 6 months.
• Eczema, active or within the past year.
• Household contact with someone who is pregnant.
• Household contact with children less than 12 years old.
• Household contact with anyone with eczema.
• Household contact with anyone with immunodeficiencies.
• Hypersensitivity to insects.
• Medical or psychiatric conditions that would make compliance unlikely.
• Evidence of depression.

Patients with the following prior conditions are excluded:

• History of immunodeficiency or chronic illness or use of immunosuppressive medications.
• Blood or blood product transfusion within previous six months.
• Eczema, active or within the past year.
• Prior receipt of experimental HIV vaccine. [Specific other requirements are stated elsewhere in the record.]

Prior Treatment:

Excluded within 6 months prior to study entry:

• Blood or blood product transfusions.

Risk Behavior:

Excluded:

• Active intravenous drug use.
• Syphilis, gonorrhea, or any sexually transmitted diseases including chlamydia or pelvic inflammatory disease within the past 6 months.
• More than 2 sexual partners in the past 6 months or sexual contact with a high-risk partner.

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