GENEVAX-HIV (APL 400-003) CANDIDATE DNA VACCINE--PILOT DOSE

GENEVAX-HIV (APL 400-003) 候选 DNA 疫苗——试验剂量

• 批准号: 6274529
• 负责人: ROB R MCGREGOR
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274529
• 关键词: AIDS education /prevention; AIDS therapy; AIDS vaccines; HIV infections; antibody formation; clinical research; clinical trial phase I; cytotoxic T lymphocyte; helper T lymphocyte; human subject; human therapy evaluation; immunoregulation; vaccine development; vector vaccine

Previous studies have suggested that a successful HIV vaccine will need to induce both broad humoral and cellular immune responses. Specifically, induction of class 1 MHC-restricted cytotoxic T lymphocytes and neutralizing antibody responses possibly against a number of viral antigens are important objectives in the design of second generation candidate AIDS vaccines. This is the first study in HIV-negative volunteers to evaluate safety, tolerance and immune response of APL 400-003 HIV DNA Vaccine using the Biojector 2000 system. The primary purpose of this project is to determine whether multiple intramuscular injections of the Genevax HIV (APL 400-003) DNA plasmid vaccine at dose levels of 100 ug and 300 ug can provoke an HIV-1 antigen-specific stimulation of the HIV negative immune system. Also, to determine if a multifaceted immune response characterized by production of HIV-specific antibodies, T helper cells and cytotoxic T lymphocytes; and which, under the appropriate conditions, may protect against infection by the Human Immunodeficiency Virus or delay the progression of disease.

先前的研究表明，成功的HIV疫苗需要 诱导广泛的体液和细胞免疫反应。 具体而言，诱导1类MHC限制性细胞毒性T 淋巴细胞和中和抗体反应可能与A 病毒抗原的数量是设计的重要目标 第二代候选艾滋病疫苗。 这是HIV阴性志愿者评估安全性的第一项研究 使用APL 400-003 HIV DNA疫苗的耐受性和免疫反应使用 Biojector 2000系统。 该项目的主要目的是确定多个 肌内注射Genevax HIV（APL 400-003）DNA质粒 剂量水平为100 ug和300 ug的疫苗会引起HIV-1 HIV阴性免疫系统的抗原特异性刺激。 还， 确定是否以多面免疫反应为特征 HIV特异性抗体，T辅助细胞和细胞毒性T的产生 淋巴细胞；在适当的条件下，哪些可以保护 反对人类免疫缺陷病毒感染或延迟 疾病的进展。