A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of rgp120/HIV-1MN (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults.
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Drug Therapy, Combination, Adjuvants, Immunologic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria Subjects must have: Normal history and physical exam. HIV negativity by ELISA within 6 weeks of immunization. CD4 count >= 400 cells/mm3. Normal urine dipstick with esterase and nitrite. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: Hepatitis B surface antigen. Medical or psychiatric condition or occupational responsibilities that preclude compliance. Active syphilis. NOTE: Subjects with serology documented to be false positive or due to a remote (> 6 months) treated infection are eligible. Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. Subjects with the following prior conditions are excluded: History of immunodeficiency, autoimmune disease, or use of immunosuppressive medications. History of anaphylaxis or other serious adverse reactions to vaccines. History of allergy to thimerosal. AS PER AMENDMENT 07/02/97: History of eczema or allergic-type reactions to rsgp120/HIV-1MN vaccine (for volunteers undergoing DTH testing). Prior Medication: Excluded: Live attenuated vaccines within 60 days prior to study entry. (NOTE: Medically indicated subunit or killed vaccines, such as influenza or pneumococcal, are allowed but should be given at least 2 weeks prior to HIV immunizations.) Experimental agents within 30 days prior to study entry. Prior HIV vaccines. AS PER AMENDMENT 07/02/97: Use of systemic steroids in the past month (for volunteers undergoing DTH testing). Prior Treatment: Excluded: Receipt of blood products or immunoglobulin within the past 6 months. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire, including history of injection drug use within the past year and higher or intermediate risk sexual behavior.
Sites / Locations
- St. Louis Univ. School of Medicine AVEG
- Univ. of Rochester AVEG
- JHU AVEG
- UW - Seattle AVEG