ACE Covid 19 Admin Supplement: Molecular Regulation of B cells and T cells in Human SLE

新冠病毒19号疫苗接种试验(ACV01) Emory请求行政补充(AS)以支持ACE新冠肺炎疫苗接种试验(ACV01)和 学习。下面，首先列出并简要描述主要组成部分，然后是预算细节 如果是这样的话。 辅助服务有三个主要组成部分： 1.新冠肺炎疫苗治疗自身免疫性疾病的ACV01介入性临床试验 A.1000万美元完成了与调查人员、地点和第一批人的详细预算的协议 (5种自身免疫性疾病，3种疗法，3种疫苗)。 B.将在上半年确定的“适应性”群体的额外资金为1000万美元 年。 C.初始队列方案已完成，FDA正在进行审查(预计 7月12日)。 D.附录：协议 2.统计和临床协调中心支持(RHO联邦系统) A.合同2022年4月30日结束后，从埃默里分包给Rho的费用为450万美元。 B.RHO将单独提交详细预算(预计为400万美元)，以便在 最初的时期。 3.新冠肺炎疫苗治疗自身免疫性疾病的ACV02观察临床研究 A.200万美元完成了与主要调查员和现场的研究计划协议；额外 调查人员将被招募。 B.预算目前从几个基本程序扩大，如抽血， 抗血清检测、加工和储存。 C.样品将在以后用于更复杂的分析，这超出了范围 当前计划，不受当前预算的支持。 D.附录：研究计划 总请求数=2,600万美元 ACV01临床试验将招募患有5种不同自身免疫性疾病(SLE、RA、MS、SSC、 3种不同的免疫抑制疗法(aCD20、MTX、MMF)随机分为 几个试验武器(例如，在接种疫苗期间停止治疗)将使用至少3种疫苗之一进行接种 主要疫苗供应商(辉瑞/BioNTech、莫德纳、扬森，其他公司预计)。就诊是收费的 通过4个参数的组合：疾病+治疗+疫苗+试验臂。这种疾病-和治疗- 目前根据访问时间、人员和评估的性质估计具体细节。

COVID 19 Vaccination Trial (ACV01) Emory requests an Admin Supplement (AS) to support the ACE COVID-19 vaccination trial (ACV01) and study. Below, first the major components are listed and described briefly, then budgeting details are provided. There are three major components of the AS: 1. ACV01 interventional clinical trial of COVID-19 vaccines in patients with autoimmune diseases. a. $10 M completed protocol with investigators, sites, and detailed budget for first cohorts (5 autoimmune diseases, 3 therapies, 3 vaccines). b. $10 M additional for the ‘adaptive’ cohorts that will be identified within the first half year. c. The protocol for the initial cohorts is complete and under review at FDA (anticipated July 12). d. Appendix: protocol 2. Statistical and Clinical Coordinating Center support (Rho Federal Systems) a. $4.5 M for subcontracting from Emory to Rho after their contract ends April 30, 2022. b. Rho will submit separately a detailed budget ($4 M expected) for support during the initial period. 3. ACV02 observational clinical study of COVID-19 vaccines in patients with autoimmune diseases. a. $2 M completed research plan protocol with lead investigators and sites; additional investigators will be recruited. b. The budget is currently scaled-up from a few essential procedures, such as blood draws, antisera measurements, and processing and storage. c. The samples will be used in more sophisticated assays later, which are beyond the scope of the current program and not supported by the current budget. d. Appendix: research plan Total request = $26 M The ACV01 clinical trial will enroll patients with 5 different autoimmune diseases (SLE, RA, MS, SSc, Pemphigus) on 3 different immunosuppressive therapies (aCD20, MTX, MMF) being randomized to several trial arms (e.g., withholding therapy during vaccination) to be vaccinated using one of at least 3 major vaccine providers (Pfizer/BioNTech, Moderna, Janssen, others expected). Patient visits are priced by combination of 4 parameters: disease + therapy + vaccine + arm of trial. The disease- and therapy- specific details are currently estimated based on visit time, personnel, and nature of the assessments.