Clinical subjects and recruitment

将设立一个核心，以支持三个研究项目中有关人类受试者的研究。这 临床受试者和招募核心将为受试者招募、筛选和评估提供集中资源。 和注册。项目1将重点关注在美国的成人自身免疫性疾病的SARS-CoV-2疫苗接种。 耶鲁-纽黑文卫生系统谁经历了B细胞耗竭治疗。虽然从主要样本 已经收集了疫苗，进行了SARS CoV-2重复疫苗接种和流感疫苗接种试验 会完成的项目2招聘将重点招聘老年人（年龄≥ 65岁）养老院和老年人 协助生活居民进行高剂量与MF 59佐剂流感疫苗的随机试验，以及 还将招募年轻人（21-39岁）作为对照。项目3将招募年轻的成年人（16-30岁）， 细胞疾病用于研究免疫失调和对肺炎球菌多糖疫苗的应答， 以及没有镰状细胞病的对照。核心也将促进皮肤活检的疫苗接种 接种疫苗后，在参与者亚组中进行部位和区域淋巴结活检，以评估组织 转录组反应。该核心还将负责确保所有人的安全和信息安全 参与者并遵守所有监管措施。核心将负责维护和 部署我们已建立的条形码样本系统，用于生成受试者编号，跟踪样本， 并映射到外部ID，与核心B（数据管理和分析）协作，其中数据 管理平台是基础。核心由具有丰富经验的调查人员领导， 具有必要的法规和临床经验的人体免疫学研究人员。因此，这 临床主题和招募核心将推进这个人类免疫学项目联盟的目标 应用程序.

A Core will be established to support investigations on human subjects in the three research projects. This Clinical Subjects and Recruitment Core will provide a centralized resource for subject recruitment, screening and enrollment. Project 1 will focus on SARS-CoV-2 vaccination in adults with autoimmune disease in the Yale-New Haven Health system who have undergone B cell depletion therapy. While samples from primary vaccination have already been collected, a trial of repeat SARS CoV-2 vaccination and of influenza vaccination will be done. Project 2 recruitment will focus on recruitment of older (age ≥ 65) nursing home and senior assisted living residents for a randomized trial of high-dose versus MF59-adjuvanted influenza vaccine, and will also recruit young adults (age 21-39) as controls. Project 3 will recruit young adults (age 16-30) with sickle cell disease for studies of immune dysregulation and response to the pneumococcal polysaccharide vaccine, together with controls without sickle cell disease. The Core will also facilitate skin biopsies of the vaccination site and regional lymph node biopsies following vaccination in a subset of participants to assess tissue transcriptomic responses. This Core will also be responsible for ensure safety and information security for all participants and for compliance with all regulatory measures. The Core will be responsible for maintaining and deploying our established barcoding sample system for generation of subject numbers, tracking of samples, and mapping to external IDs, collaborating with Core B (Data Management and Analysis), where data management platforms are based. The Core is led by investigators with extensive experience carrying out human immunology studies who have the necessary regulatory and clinical experience. Consequently, this Clinical Subjects and Recruitment Core will advance the goals of this Human Immunology Project Consortium application.