Determining an Effective Site (Groin Versus Arm) for Giving HIV Vaccines

Inclusion Criteria

• HIV uninfected
• Low risk for 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 subject report) for 6 months prior to study entry
• Born after 1970
• Willingness to abstain from sexual activity for up to 30 days after each vaccination
• Willingness to abstain from receptive anal intercourse during the 20 months of the study
• Available for follow-up during the 20 month duration of the study
• Acceptable methods of contraception

Exclusion Criteria

• Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, radiation, or large doses of corticosteroids
• Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea
• Medical or psychiatric condition or occupational responsibilities which preclude volunteer's compliance with the protocol; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis
• Prior smallpox or vaccinia-based vaccination
• 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 TBC-3B immunizations.
• 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)
• Sexually transmitted disease in the year prior to study entry
• Genital HSV (herpes) or other ulcerative genital lesions
• Active HBV (hepatitis B) or HCV (hepatitis C) infection
• Nonprescribed injection drug use
• Pregnant or lactating women
• Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema)
• Use of experimental agents within 30 days prior to study
• Household contacts with or ongoing occupational exposure to any of the following: pregnant women; children < 12 months of age; people with acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema); people with an immunodeficiency or using immunosuppressive medications