A Phase I Double Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of the Aventis Pasteur ALVAC-HIV (vCP205) Administered to the Groin Area Versus the Deltoid Area

Fecha de inicio: 1 de junio de 2006

Inclusion Criteria * HIV uninfected * Low risk for acquiring HIV-1 (no sexually transmitted disease within 1 year of study entry, no history of injection drug use, no sex with an HIV infected individual or active injection drug user within 6 months of study entry, no unsafe sexual activity with unknown partners) or mutually monogamous relationship with a known HIV seronegative partner (per report) for 6 months prior to study entry * Willing to abstain from receptive anal intercourse during the 14 months of the study * Available for follow-up during the 14 months of the study * Acceptable methods of contraception Exclusion Criteria * Pregnant or lactating woman * Allergy to eggs or neomycin * Live attenuated vaccines within 60 days of study. Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 1 month prior to study immunizations. * Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea * Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, or radiation * Use of immunosuppressive medications within 6 months prior to study entry * Thyroid disease * Unstable asthma * Exposure to or active tuberculosis * Seizure disorders * Bleeding disorders * Splenectomy * Hypertension (blood pressure less than 150/100 if on medication) * Medical or psychiatric condition or occupational responsibilities which preclude participant's compliance with the study; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis. * Received HIV vaccines or placebo in a prior HIV vaccine trial * Blood products within 120 days prior to study entry * Immunoglobulin within 60 days prior to study entry * Anaphylaxis or other serious adverse reactions to vaccines * Serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) * Nonprescribed injection drug use * Investigational research agents within 30 days prior to study entry