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

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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.