SAFETY/IMMUNE RESPONSE TO DNA PLASMID VACCINE IN ASYMPTOMATIC HIV

无症状 HIV 患者对 DNA 质粒疫苗的安全性/免疫反应

• 批准号: 2757459
• 金额: $ 0.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2757459
• 关键词: AIDS therapy; AIDS vaccines; HIV infections; T lymphocyte; antigen antibody reaction; cellular immunity; clinical research; clinical trial phase I; drug screening /evaluation; human subject; human therapy evaluation; immunity; outcomes research; pathologic process; vector vaccine

The primary purpose of this project is to determine whether multiple intramuscular injections of the APL 400-003 HIV DNA plasmid vaccine at dose levels of 30, 100, and 300 micrograms can be administered safely to asymptomatic HIV-infected patients. As a secondary objective, the protocol is designed to evaluate whether these multiple intramuscular injections of the APL 400-003 Vaccine might enhance existing antigen- specific immune responses, especially T cell responses, when administered to asymptomatic HIV-infected patients and to characterize the immune response profile of these patients pre- and post-injection, and to monitor indicators of progression of HIV infection in these asymptomatic HIV- infected patients.

该项目的主要目的是确定是否有多个 APL 400-003 HIV DNA疫苗肌肉注射 30微克、100微克和300微克的剂量水平可以安全地给予 无症状的艾滋病毒感染者。作为次要目标， 方案旨在评估这些多发性肌肉内的 注射APL 400-003疫苗可能会增强现有的抗原- 特异性免疫反应，尤其是T细胞反应 对无症状的HIV感染患者和免疫学特征 这些患者在注射前和注射后的反应谱，并监测 在这些无症状艾滋病毒中艾滋病毒感染进展的指标- 被感染的病人。