Status and phase
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To evaluate safety and immune response in HIV-infected patients treated with multiple injections of APL 400-003 vaccine.
PER 2/27/96 AMENDMENT: To evaluate the safety of the vaccine when administered via the Biojector 2000 Needle-Free Injection Management System.
Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of the genes into host cells. Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies, killer T-cells, and helper T-cells. The safety of this new vaccine approach needs to be assessed.
PER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination.
Full description
Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of the genes into host cells. Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies, killer T-cells, and helper T-cells. The safety of this new vaccine approach needs to be assessed.
PER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination.
Patients are given intramuscular injections of APL 400-003 at one of three doses (30, 100, or 300 mcg) on day 0 and again at weeks 10 and 20, and followed for 16 weeks after the final dose. An 8-week period prior to initial dosing is required for immortalizing the patient's PBMCs.
PER 2/27/96 AMENDMENT: Five patients will be evaluated at the 300 mcg dose with the Biojector 2000.
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Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
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Data sourced from clinicaltrials.gov
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