A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205, Combined With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Healthy, HIV-1 Uninfected Volunteers

Inclusion Criteria Volunteers must have: * Negative ELISA for HIV within 8 weeks prior to immunization. * CD4 count of 400 cells/mm3 or higher. * Normal history and physical examination. * Viable EBV line prior to initial immunization. \[AS PER AMENDMENT 4/30/99: * Negative anti-dsDNA antibodies (for volunteers receiving booster vaccine).\] Exclusion Criteria Co-existing Condition: Volunteers with the following conditions or symptoms are excluded: * Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol. * Recent suicidal ideation or psychosis. * Active syphilis. NOTE: * If the serology is documented to be a false positive or due to a remote (greater than 6 months) treated infection, the volunteer is eligible. * Active tuberculosis. NOTE: * Volunteers who have a positive PPD and a normal chest x-ray showing no evidence of TB and who do not require INH therapy are eligible. * Positive for hepatitis C antibody or hepatitis B surface antigen. * Allergy to eggs, neomycin, or thimerosal. \[AS PER AMENDMENT 4/30/99: * Hypersensitivity to bupivacaine or other amide-type anesthetics (e.g., lidocaine, mepivacaine) for volunteers receiving booster vaccine).\] Concurrent Medication: Excluded: Lithium or cimetidine. Volunteers with the following prior conditions are excluded: * History of immunodeficiency, chronic illness, or autoimmune disease. * History of cancer unless there has been surgical excision with reasonable assurance of cure. * History of suicide attempts or past psychosis. * History of anaphylaxis or other serious adverse reactions to vaccines. * History of serious allergic reaction to any substance requiring hospitalization or emergent care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). \[AS PER AMENDMENT 11/13/97: * History of cardiac disease or cardiac arrhythmias.\] Prior Medication: Excluded: * Live attenuated vaccines within 60 days of study. NOTE: * Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations. * Experimental agents within 30 days prior to study. * Blood products or immunoglobulin in the past 6 months. * HIV-1 vaccines or placebo as part of a previous HIV vaccine trial. * Immunosuppressive medications. Risk Behavior: Excluded: Volunteers with an identifiable higher-risk behavior for HIV infection (i.e., AVEG Risk Group C or D), including a history of injection drug use within 12 months prior to enrollment or higher-risk sexual behavior as defined by the AVEG.