a phase i trial of apl 400-003 vaccine: safety and immune response evaluations of multiple injections at escalating doses in asymptomatic hiv-infected patients

Conditions: HIV Infections

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.

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.

Eligibility criteria:
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.

Keywords: vaccines, synthetic aids vaccines dna, viral