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 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.