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

ACE Covid 19 管理补充：人类 SLE 中 B 细胞和 T 细胞的分子调节

• 批准号: 10456447
• 负责人: Ignacio E. Sanz
• 金额: $ 2679.42万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-27 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456447
• 关键词: Administrative Supplement; Autoimmune Diseases; B-Lymphocytes; Biological Assay; Blood; Budgets; COVID-19; COVID-19 vaccination; COVID-19 vaccine; Clinical; Clinical Research; Clinical Trials; Contracts; Disease; Enrollment; Human; Human Resources; Immune Sera; Intervention; Lead; Measurement; Molecular; Nature; Patients; Pemphigus; Price; Procedures; Protocols documentation; Provider; Randomized; Regulation; Research; Research Personnel; Sampling; Site; System; Systemic Lupus Erythematosus; T-Lymphocyte; Therapeutic immunosuppression; Time; Vaccinated; Vaccination; Vaccines; Visit; arm; base; cohort; programs; recruit; rho; scale up; vaccine trial

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.

COVID 19疫苗接种试验（ACV 01） 埃默里大学要求行政补充（AS），以支持ACE COVID-19疫苗接种试验（ACV 01）， study.下面，首先列出主要组成部分并简要说明，然后是预算细节 提供了 AS有三个主要组成部分： 1. ACV 01 COVID-19疫苗在自身免疫性疾病患者中的干预性临床试验。 a.与研究者、研究中心一起完成了1000万美元的方案，并为第一个队列提供了详细的预算 （5种自身免疫性疾病，3种疗法，3种疫苗）。 B.为将在上半年确定的“适应性”队列增加1000万美元 年 C.初始队列的方案已完成，并正在接受FDA的审查（预计 7月12日）。 D.附录：方案 2.统计和临床协调中心支持（Rho联邦系统） a. 450万美元用于在合同于2022年4月30日结束后从Emory分包给Rho。 B. Rho将单独提交一份详细的预算（预计为400万美元），用于在 初期。 3. ACV 02 COVID-19疫苗在自身免疫性疾病患者中的观察性临床研究。 a.与主要研究者和研究中心完成200万美元的研究计划方案;额外 将招聘调查员。 B.目前，预算从抽血等几个基本程序增加， 抗血清测量以及处理和储存。 C.这些样本将用于更复杂的检测，这超出了范围 目前的计划，不支持目前的预算。 D.附录：研究计划 申请总额= 2 600万美元 ACV 01临床试验将招募患有5种不同自身免疫性疾病（SLE、RA、MS、SSc、 天疱疮）接受3种不同的免疫抑制治疗（aCD 20、MTX、MMF），随机分配至 几个试验臂（例如，在接种疫苗期间停止治疗）使用至少3种 主要疫苗供应商（辉瑞/BioNTech、Moderna、杨森，预期还有其他供应商）。患者就诊价格 4个参数的组合：疾病+治疗+疫苗+试验组。疾病和治疗 具体细节目前正在根据访问时间，人员和评估性质进行估计。