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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential ...

Gender

ALL

Eligibility criteria

• • 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).