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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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
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HIV Infections

Intervention / Treatment
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* Biological: APL 400-003


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: APL 400-003|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines, Synthetic, AIDS Vaccines, DNA, Viral