A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers

Exclusion Criteria

• •Co-existing Condition:
• •Subjects with the following symptoms or conditions are excluded:
• •Positive hepatitis B surface antigen.
• •Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
• •Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
• •Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
• •Allergy to egg products or neomycin.
• •Subjects with the following prior conditions are excluded:
• •History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
• •History of anaphylaxis or other serious adverse reactions to vaccines.
• •Prior immunization against rabies.
• •History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
• •Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
• •History of cancer unless there has been surgical excision that is considered to have achieved cure.
• •Prior Medication:
• •Excluded:
• •Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
• •Experimental agents within 30 days prior to study entry.
• •Prior HIV vaccines.
• •Prior rabies immunization.
• •Prior Treatment:
• •Excluded:
• •Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as
• •injection drug use within past 12 months.
• •higher or intermediate risk sexual behavior.