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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002350

Run by

Apollon

People needed

16

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Pennsylvania Med Ctr — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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