Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate...
Detailed Description
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 va...
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).
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
End Date :
February 1 2001
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00001088
Start Date
July 1 1997
End Date
February 1 2001
Last Update
September 29 2008
Active Locations (4)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
3
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
4
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States, 98144