A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)

Inclusion Criteria

Patients must be:

• Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
• Available for 1 year of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• History of positive PPD (tuberculin test).
• Positive syphilis serology (e.g., VDRL).
• Positive for circulating hepatitis B antigen.

Patients with the following are excluded:

• They or their sexual partners have identifiable high-risk behavior for HIV infection.
• History of immunodeficiency or chronic illness.
• Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

• Immunosuppressive medications.

Prior Treatment:

Excluded:

• Blood transfusions or cryoprecipitates within the past 6 months.

Risk Behavior: Excluded:

• High-risk behavior for HIV infection.
• History of intravenous drug use.
• More than one sexual partner in the last 6 months.

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