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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Apollon
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •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/mm
- •Normal hematologic, renal, hepatic, metabolic, and endocrine function.
- •No more than one patient over 50 years of age is permitted at each dose level.
排除标准
- •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:
- •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:
- •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:
- •Prior radiotherapy. IV drug use or any other high-risk behavior.