A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers

Date de début de l'étude : 1 juillet 1997

Inclusion Criteria Patients must have: * Negative ELISA for HIV within 8 weeks of immunization. * CD4 count \>= 400 cells/mm3. * Normal history and physical examination. * Negative for Hepatitis B surface antigen. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: * Positive for anti-dsDNA antibodies. * Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol. * Present psychosis. * Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., \> 6 months treated, infection). * Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy). Concurrent Medication: Excluded: * Immunosuppressive medications. Patients with the following prior conditions are excluded: * History of immunodeficiency, chronic illness, or autoimmune disease. * History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure. * History of suicide attempts, recent suicidal ideation or past psychosis. * History of anaphylaxis or other serious adverse reactions to vaccines. * History of severe allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). * Hypersensitivity to bupivacaine or other amide-type anesthetics. Prior Medication: Excluded: * Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial. * Use of experimental agents within 30 days prior to study. * Live attenuated vaccines within 60 days of study. * Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) within 2 weeks prior to study. Prior Treatment: Excluded: Receipt of blood products or immunoglobulin in the past 6 months. Risk Behavior: Excluded: Volunteers having identifiable higher risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection, specifically: * History of injection drug use within the last 12 months prior to enrollment. * Higher or intermediate risk sexual behavior as defined by the AVEG (i.e., meeting the criteria for AVEG Risk Group C or D).