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

Launched by APOLLON · Aug 30, 2001

Keywords

ClinConnect Summary

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-conta...

Gender

ALL

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.