Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU)

项目摘要 本补充提案概述了新冠肺炎预防网络的科学议程。 研究将在纽约大学VTEU进行。参与实施新冠肺炎疫苗。 疗效试验“一项第三阶段随机、双盲、安慰剂对照的成人多中心研究 检测非复制型ChAdOx1载体疫苗AZD1222的安全性、有效性和免疫原性 为了预防新冠肺炎的入侵。“除上述事项外，并作为补充要求进一步解决 鉴于CoVPN的使命，我们正在为其他CoVPN研究“和其他与CoVID相关的研究”申请资金。 我们计划在CoVPN-单抗(MAb)研究中进行另一项研究：阶段3， 随机、双盲、安慰剂对照研究--评估抗刺SARS的疗效和安全性 冠状病毒-2单抗预防家庭接触者感染SARS-CoV-2的研究 感染了SARS-CoV-2。 随着新冠肺炎的全球流行，我们认识到对修改新冠肺炎的疫苗的重大需求 SARS-CoV-2感染者。我们将进行的疫苗试验是3期，安慰剂对照，双倍- 盲法研究将测试AZD1222，一种复制缺陷的重组黑猩猩腺病毒的疗效 表达SARS-CoV-2刺突(S)表面糖蛋白，以修饰18岁成年人的新冠肺炎病 年龄越大越好。参与者将从美国各地多达100个临床试验地点招募，使用数据 分析以不同种族和民族特征的高危个人为目标。 我们将进行的MAB研究是一项关键的第三阶段随机、双盲、安慰剂对照研究 与SARS-CoV-2感染者有家庭接触的成年人 活跃的新冠肺炎爆发。理想的预防药剂应该是快速有效的，应该 预防多种病毒变种。一种单抗联合疗法，具有两种不同的 结合SARS-CoV-2刺突蛋白(S)结合部分不同区域的单抗 并促进进入宿主细胞，是为了实现这些目标而开发的。一种单抗组合 抗SARS-CoV-2暴露后预防，既可以防止疾病发展，也可以 减少病毒的获取或脱落可能是减少病毒传播和限制症状的关键 以及感染后的不良后果。 我们还要求现场准备资金，并为穆利根博士作为额外的人与生物圈计划的国家PI的作用提供资金 研究(礼来公司在养老院居民和工作人员中进行的MAB，用于新冠肺炎的预防)。

PROJECT ABSTRACT This supplement proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) research to be carried out at the NYU VTEU. We will participate in the implementation of a COVID-19 vaccine efficacy trial “A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, A Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19.” In addition to the above, and as a supplement request to further address the mission of the CoVPN, we are requesting funds for other CoVPN studies “and other COVID-related research”. We plan to conduct an additional study within the CoVPN – Monoclonal Antibody (mAb) Studies: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS- CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2. With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. The vaccine trial we will conduct is a phase 3, placebo-controlled, double- blinded study will test the efficacy of AZD1222, a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein, to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from up to 100 clinical trial sites across the US, using data analytics to target high risk individuals with a diverse racial and ethnic profile. The MAB study we will conduct is a pivotal phase 3 randomized, double-blind, placebo-controlled study in adults with household contact exposure to individuals with SARS-CoV-2 infection in geographic areas with an active COVID-19 outbreak. An ideal agent for prophylaxis should be fast acting and highly effective and should protect against multiple viral variants. A monoclonal antibody (mAb) combination therapy, with two different monoclonal antibodies that bind distinct regions of the portion of the SARS-CoV-2 spike (S) protein that bind to and facilitate entry into host cells, has been developed in order to achieve these goals. A mAb combination against SARS-CoV-2 for post-exposure prophylaxis that can either prevent the development of disease or reduce viral acquisition or shedding could be key to reducing transmission of the virus and limiting symptoms and adverse outcomes following infection. We also request site preparedness funds, and fund for Dr Mulligan’s role as national PI of an additional MAB study (Lilly MAB in nursing home residents and staff, for COVID-19 prevention).