A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Vaccinia Virus, HIV-1, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria Subjects must have: Normal history and physical exam. Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). T4 count >= 800 cells/mm3. Normal chest x-ray and urinalysis. Negative hepatitis B surface antigen. Negative HIV p24 antigen test. Normal skin reactivity by Merieux test. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: Positive PPD. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, or use of immunosuppressive medications. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. Prior Treatment: Excluded: Prior blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including: Any history of IV drug use. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Sites / Locations
- St. Louis Univ. School of Medicine AVEG