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: 6303412
• 负责人: ROB R MCGREGOR
• 金额: $ 2.51万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6303412
• 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，成功的艾滋病毒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淋巴细胞和可能针对许多病毒抗原的中和抗体应答是设计第二代候选AIDS疫苗的重要目标。这是首次在HIV阴性志愿者中使用Biojector 2000系统评价APL 400-003 HIV DNA疫苗的安全性、耐受性和免疫应答的研究。本项目的主要目的是确定多次肌内注射100 μ g和300 μ g剂量水平的Genevax HIV（APL 400-003）DNA质粒疫苗是否能引起HIV阴性免疫系统的HIV-1抗原特异性刺激。此外，以确定是否有多方面的免疫反应，其特征是产生艾滋病毒特异性抗体，T辅助细胞和细胞毒性T淋巴细胞;在适当的条件下，可以保护免受人类免疫缺陷病毒感染或延缓疾病的进展。