HIV Infections
Conditions
Keywords
Vaccines, Synthetic, AIDS Vaccines, DNA, Viral
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICALAPL 400-003
Sponsors
Apollon
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Low doses of nonprescription NSAIDS, acetaminophen, ibuprofen, aspirin, replacement hormone therapy, and vitamin supplements. Patients must have: * Asymptomatic HIV infection with no acute related infection. * CD4 count \>= 500 cells/mm3. * Normal hematologic, renal, hepatic, metabolic, and endocrine function. NOTE: * No more than one patient over 50 years of age is permitted at each dose level.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Residual toxicity from prior drug treatment. * Hypersensitivity to bupivacaine or amide-type local anesthetic. * Active viral hepatitis, autoimmune disorders, or other debilitating chronic diseases. Concurrent Medication: Excluded: * Medications that affect immune function. * Antiretrovirals. Patients with the following prior conditions are excluded: * Malignancies other than curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * History of anaphylaxis to vaccines. Prior Medication: Excluded: * Prior immunization with any experimental HIV vaccines. * Other experimental therapy within 30 days prior to study entry. * Prior cancer chemotherapy. * Antiretrovirals within 3 months prior to study entry. Prior Treatment: Excluded: * Prior radiotherapy. IV drug use or any other high-risk behavior.
Countries
United States
Outcome results
None listed