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