A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
HIV Infections, HIV Seronegativity
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, Smallpox Vaccine, 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 test for HIV by ELISA within 6 weeks prior to immunization. Negative test for HIV by Western blot. CD4 count >= 400 cells/mm3. No history of smallpox vaccination. Normal urine dipstick with esterase and nitrate. No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: Positive for hepatitis B surface antigen. Medical or psychiatric condition or occupational responsibilities that preclude compliance. Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible). Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible). Eczema. Household contact with persons meeting any of the following criteria: pregnancy, < 12 months of age, eczema, or immunodeficiency disease or use of immunosuppressive medications. Subjects with the following prior conditions are excluded: History of anaphylaxis or other serious adverse reactions to vaccines. Eczema within the past year. PER 8/94 AMENDMENT: History of cancer unless surgically excised with reasonable assurance of cure. PER 8/94 AMENDMENT: History of serious allergic reaction requiring hospitalization or emergent medical care. Prior Medication: Excluded: Prior HIV vaccines. Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations. Experimental agents within the past 30 days. Prior Treatment: Excluded: Blood products or immunoglobulin within the past 6 months. Higher risk behavior for HIV infection as determined by screening questionnaire, including: History of injection drug use within 12 months prior to study entry. Higher or intermediate risk sexual behavior.
Sites / Locations
- St. Louis Univ. School of Medicine AVEG
- UW - Seattle AVEG