Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm
HIV Infections, HIV Seronegativity

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Preventive Vaccine, ALVAC Vaccine, Immunization Site, Deltoid, Groin, Targeted Inguinal Lymph Node, TILN
Eligibility Criteria
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
Sites / Locations
- UCLA Center for HIV and Digestive Diseases
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Participants will receive vaccine injections in the groin area or the upper arm
Participants will receive vaccine placebo injections in the groin area or the upper arm