Clinical subjects and recruitment

将设立一个核心，以支持在三个研究项目中对人体受试者的调查。这 临床学科和招聘核心将为学科招聘、筛查提供集中资源 和招生。项目1将侧重于在中国为患有自身免疫性疾病的成年人接种SARS-CoV-2疫苗。 耶鲁-纽黑文卫生系统接受了B细胞耗尽治疗。而来自第一批的样本 已经收集了疫苗，重复接种SARS CoV-2疫苗和流感疫苗的试验 都会完成的。项目2招聘将侧重于招聘老年人(65岁≥)养老院和老年人 协助活着的居民进行大剂量与MF59佐剂流感疫苗的随机试验，以及 也将招募年轻人(21-39岁)作为对照。项目3将招募持镰刀的年轻人(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反应， 与未患镰状细胞病的对照组一起。核心还将促进接种疫苗的皮肤活组织检查 在一组参与者中接种疫苗后进行局部和区域淋巴结活检以评估组织 转录剪裁反应。该核心还将负责确保所有人的安全和信息安全 与会者和遵守所有监管措施。核心将负责维护和 部署我们建立的条形码样本系统，用于生成受试者编号、跟踪样本、 以及映射到外部ID，与核心B(数据管理和分析)协作，其中数据 管理平台是以。核心由具有丰富执行经验的调查人员领导 具有必要的调节和临床经验的人体免疫学研究人员。因此，这 临床科目和招募核心将推进该人类免疫学项目联盟的目标 申请。

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.