Rho Federal Systems Division, Inc. NIAID DAIT SACCC

项目摘要/摘要 SARS-CoV-2病毒引发了一场全球大流行，超过2800万例和超过 截至2021年3月1日，美国有500,000人死亡(疾病控制和预防中心 数据跟踪器)。美国食品和药物管理局(FDA)已向两名 基因疫苗、辉瑞-生物技术新冠肺炎疫苗和现代新冠肺炎疫苗。两种疫苗 使用新的信使核糖核酸脂质纳米粒递送系统，并已被证明在 在大型临床试验中预防疾病。 自从在更广泛的人群中引入这些疫苗以来，就有严重过敏反应的报道。 用这些产品接种疫苗。根据已公布的消息来源，过敏反应的发生率 辉瑞-生物科技新冠肺炎疫苗估计为百万分之十的疫苗剂量，约为10- 比通常使用的疫苗的过敏率高出一倍，过敏反应的发生率 据报道，摩迪纳新冠肺炎疫苗的发病率为百万分之2.5。这些反应中的大多数已经 发生在有过敏背景的个人中，大量发生在有 过敏反应。 本项目的目的是为RHO联邦系统司作为统计部门提供支持 和临床协调中心，负责方案的制定、实施、数据分析和报告 结果这是一项多中心、随机、初始盲的2期研究，有两个主要目标。第一个是 评估辉瑞生物科技和现代新冠肺炎的全身过敏反应比例 对食物、毒液、药物或疫苗有严重过敏反应史的个人接种疫苗(高- 过敏[HA])，或肥大细胞病史(MCD)。第二，如果HA/MCD人群的风险是 可以证明的是，确定HA/MCD人群中的比例是否高于 非特应性研究人群。如果出现大量的直接全身过敏反应 或者两种疫苗都有，本研究的另一个重点是开始评估过敏的机制(S) 新冠肺炎疫苗的反应，并确定特定的风险因素是否可以通过患者病史来确定 或者生物标记物测试。 这些信息对于正确建议高度过敏患者和肥大细胞疾病患者是至关重要的。 关于这些疫苗，保持公众对这些疫苗的安全性的信任，并尽量减少疫苗 对于使用这项新技术的这些和未来的疫苗，人们犹豫不决。

PROJECT SUMMARY / ABSTRACT The SARS-CoV-2 virus has triggered a world-wide pandemic with over 28 million cases and more than 500,000 deaths in the United States as of March 1, 2021 (Centers for Disease Control and Prevention, COVID Data Tracker). The Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) to two mRNA vaccines, the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine. Both vaccines use the new mRNA lipid nanoparticle delivery system and have been proven to be strikingly effective in preventing disease in large clinical trials. Since introduction of these vaccines in a wider population, there have been reports of severe allergic reactions to vaccination with these products. According to published sources, the incidence rate of anaphylaxis for the Pfizer-BioNTech COVID-19 Vaccine is estimated at 10/1,000,000 vaccine doses, which is approximately 10- fold higher than the rate typically seen with commonly used vaccines, and the rate of anaphylaxis for the Moderna COVID-19 Vaccine has been reported as 2.5/1,000,000. The majority of these reactions have occurred in individuals with an allergic background and a large number in individuals with a history of anaphylaxis. The purpose of this project is to provide support for Rho Federal Systems Division to serve as the Statistical and Clinical Coordinating Center for protocol development, implementation, data analysis, and reporting of results for a multicenter, randomized, initially blinded, phase 2 study with two principal aims. The first is to estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech and the Moderna COVID-19 vaccines in individuals with a history of severe allergic reactions to foods, venoms, drugs, or vaccines (High- Allergy [HA]), or a history of mast cell disorders (MCD). The second, if the risk in the HA/MCD population is demonstrable, is to determine whether the proportions are higher in the HA/MCD population compared to a non-atopic study population. In the event a significant number of immediate systemic allergic reactions to either or both vaccines are seen, another focus of this study is to begin evaluating the mechanism(s) of allergic reactions to the COVID-19 vaccines, and to determine if specific risk factors can be identified by patient history or biomarker testing. This information will be crucial to properly advise highly allergic individuals and those with mast cell disorders regarding these vaccines, to maintain public trust in the safety of these vaccines, and to minimize vaccine hesitancy for these and future vaccines using this new technology.