AIDS VACCINE EVALUATION UNIT

艾滋病疫苗评估单位

• 批准号: 2294586
• 负责人: MARY L CLEMENTS
• 金额: $ 3.65万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-02-01 至 1995-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2294586
• 关键词: AIDS; VACCINE; EVALUATION; UNIT

The objective of this project is to conduct Phase I and Phase II clinical trials of candidate AIDS vaccines among HIV-seronegative volunteers at low risk of infection. The Offeror shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities as needed to conduct collaborative trials sponsored by the National Institutes of Health and done at multiple institutions. The goal of these Phase I ad Phase II studies is to define the safety, toxicity, and immunogenicity of such vaccines. The Offeror will cooperate as appropriate with other component parts of the AIDS Vaccine Evaluation Group (AIDS Vaccine Evaluation Units, Central Immunology Laboratory, Data Coordinating and Analysis Center, and Central Repository). The Offeror will follow common protocols to test approved candidate vaccine and to determine the optimal dosage regimen. The Offeror will recruit, screen, and inoculate an average of 200 volunteers per year. The Offeror will conduct appropriate laboratory evaluations for toxicity (hematologic, hepatic/renal, gastrointestinal, neurologic, dermatologic), for viral antigens and antibodies (ELISA, Western Blot, neutralization assays), and for changes in immunologic function (changes in T4/T8 cell counts, assays of cell mediated immunity, skin tests). The Offeror will be responsible for maintaining individual confidential patient records. The Offeror will record pertinent data obtained from the clinical trials, enter the data onto a microcomputer, and transmit this dat via modem to the Data Coordinating and Analysis Center.

该项目的目的是进行I期和II期临床 在低艾滋病毒志愿者中，候选艾滋病疫苗的试验 感染的风险。 要约人应提供所有必要的服务， 根据需要的合格人员，材料，设备和设施 进行国立卫生研究院赞助的合作试验 并在多个机构完成。 这些阶段I广告二期的目标 研究是为了定义此类的安全性，毒性和免疫原性 疫苗。 要约人将与其他组件合作 AIDS疫苗评估组的一部分（AIDS疫苗评估单元， 中央免疫学实验室，数据协调和分析中心，以及 中央存储库）。 要约人将遵循共同的方案以测试批准的候选疫苗 并确定最佳剂量方案。 要约人将招募 屏幕，每年平均接种200名志愿者。 要约人 将对毒性进行适当的实验室评估（血液学， 肝/肾脏，胃肠道，神经系统，皮肤病学），用于病毒 抗原和抗体（ELISA，Western印迹，中和测定）和 对于免疫功能的变化（T4/T8细胞计数的变化，测定 细胞介导的免疫力，皮肤测试）。 要约人将负责维护个人机密 患者记录。 要约人将记录从 临床试验，将数据输入微型计算机，然后传输此DAT 通过调制解调器到达数据协调和分析中心。