A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria Volunteers must have: Normal history and physical exam. HIV negativity. CD4 count >= 400 cells/mm3. Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry. Normal urine dipstick with esterase and nitrite. Exclusion Criteria Co-existing Condition: Volunteers with the following symptoms or conditions are excluded: Active tuberculosis. Occupational or other responsibilities that would prevent completion of study. Volunteers with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study. History of anaphylaxis or other serious adverse reactions to vaccines. History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy. Acute gastroenteritis or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: Live or attenuated vaccine within the past 60 days. Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.
Sites / Locations
- Univ of California at San Francisco Gen Hosp