A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers

Inclusion Criteria Volunteers must have: Negative ELISA for HIV within 8 weeks of immunization. No envelope bands in Western blot for HIV-1 within 8 weeks of immunization. Normal history and physical examination. Exclusion Criteria Co-existing Condition: Volunteers with the following conditions are excluded: Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol, including recent suicidal attempt or ideation or present psychosis. Active syphilis (if the serology is documented to be a false positive or due to a remote [more than 6 months] treated infection, the volunteer is eligible). Active tuberculosis (volunteers with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible). Allergy to egg products or neomycin (used to prepare ALVAC vaccines). Occupational or household exposure to birds (no known pathogenicity of avipox for birds). Episode of severe diarrhea within 1 week prior to immunization. Abnormal pelvic exam with evidence of sexually transmitted disease or other genital tract infection or trauma, including vaginitis, cervicitis, ecchymosis, vulvar or cervicovaginal lesions or abrasions, or chronic cervical and/or abnormal PAP smear changes. Recent history of rectal bleeding or repeatedly positive hemocult test (within 1 month). Positive for Hepatitis B surface antigen. Volunteers with the following prior conditions are excluded: History of immunodeficiency, chronic illness (in particular, chronic inflammatory disease or gastroenteritis), malignancy, or autoimmune disease. History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure. History of anaphylaxis or history of other serious adverse reactions to vaccines. History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). 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. HIV-1 vaccines or placebo received in a previous HIV vaccine trial. Previous immunization against rabies. Prior Treatment: Excluded: Prior hysterectomy. Blood products or immunoglobulin in the past 6 months. Risk Behavior: Excluded: Volunteers with identifiable higher-risk behavior, or whose partners have an identifiable higher-risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection (i.e., AVEG Risk Groups C or D); specific exclusions include: history of injection drug use within the last 12 months prior to enrollment or higher-risk sexual behavior as defined by the AVEG.