Clinical Immunology Services Core

临床免疫学服务核心

• 批准号: 9233907
• 负责人: Sarah Jane Schlesinger
• 金额: $ 21.98万
• 依托单位: ROCKEFELLER UNIVERSITY
• 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/9233907
• 关键词: Archives; Clinical; Clinical Immunology; Clinical Protocols; Clinical Trials; Consent; Data; Freezing; Hepatitis B Vaccines; Human; Immunology; Influenza; Institutional Review Boards; Instruction; Pathway interactions; Process; Protocols documentation; Sampling; Services; University Hospitals; Vaccine Adjuvant; Vaccines; human subject protection; vaccine response

The Clinical Immunology Services Core will serve all of the projects in the CCHI. It is at the center of all of the activities in the human immunology clinical trials. The major functions of the core are: Clinical and regulatory support for all of the scientific studies on the samples collected from human clinical immunology trials conducted under the auspices of these projects. The Core will support the consent for the scientific use of and the regulatory requirements associated with the use of human clinical samples that have been collected under previously conducted IRB approved protocols at The Rockefeller University Hospital. These samples are from the seven already IRB approved clinical protocols of experimental vaccines and vaccine adjuvants. The Core will also provide clinical and regulatory support for the conduct of ongoing and planned clinical trials of licensed influenza, pneumococcal, meningicoccal, and hepatitis B vaccines proposed in Projects 1 and 4. The Core will support all of the regulatory, human subjects protection, and clinical execution of these clinical trials. In addition the Clinical Immunology Services Core will also complete all of the data entry and management associated with these proposed protocols.

临床免疫学服务核心将为CCHI的所有项目提供服务。它是所有 人类免疫学临床试验的活动。核心的主要功能是：临床和 对从人类临床免疫学采集的样本进行的所有科学研究提供监管支持 在这些项目的主持下进行的试验。核心将支持科学使用的同意 以及与使用已被 根据之前在洛克菲勒大学医院进行的IRB批准的方案采集。这些 样品来自七个已经IRB批准的实验性疫苗和疫苗的临床方案 佐剂核心还将为正在进行和计划进行的 在美国进行的流感、肺炎球菌、脑膜炎球菌和B型肝炎疫苗的临床试验 项目1和4。核心将支持所有监管、人类受试者保护和临床 执行这些临床试验。此外，临床免疫学服务中心还将完成所有 与这些提议的协议相关联的数据输入和管理。