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
Current as of December 07, 2023
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 ...
- 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:
- 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:
- 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:
- Receipt of blood products or immunoglobulin in the past 6 months.
- Risk Behavior:
- 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).
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Birmingham, Alabama, United States
Seattle, Washington, United States
Nashville, Tennessee, United States
Rochester, New York, United States
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