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

纽约大学疫苗和治疗评估中心（NYU VTEU）成立

• 批准号: 10228783
• 负责人: Mark Joseph Mulligan
• 金额: $ 921.48万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-21 至 2021-09-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10228783
• 关键词: 18 year old; 2019-nCoV; Address; Adenoviruses; Adult; Age-Years; Antibody Response; Antigens; Binding; Binding Proteins; Biological Assay; Biometry; COVID-19; COVID-19 pandemic; COVID-19 vaccine; Cells; Cellular Assay; Clinical; Clinical Trials; Cohort Studies; Combined Modality Therapy; Communicable Diseases; Data Analytics; Development; Disease; Disease Outbreaks; Dose; Double-Blind Method; Emergency department visit; Evaluation; Exposure to; Eye; Funding; Geographic Locations; Goals; HIV vaccine; Health; Household; Immune; Immune response; Immunity; Immunology; Individual; Infection; Infection Control; Knowledge; Laboratories; Lead; Leadership; Malaria; Mediating; Membrane Glycoproteins; Mission; Monoclonal Antibodies; Morbidity - disease rate; Multicenter Studies; New York; Nursing Homes; Pan Genus; Participant; Persons; Phase; Placebos; Population; Preparation; Prevention; Prophylactic treatment; Protocols documentation; Quality Control; Randomized; Randomized Clinical Trials; Readiness; Recombinants; Research; Research Methodology; Risk; Role; Safety; Sampling; Serological; Serum; Severities; Site; Symptoms; System; Typhoid Fever; Universities; Vaccines; Validation; Variant; Viral; adverse outcome; clinical trial analysis; coronavirus disease; design; efficacy study; efficacy testing; efficacy trial; high risk; immune function; immunogenicity; mortality; neutralizing antibody; placebo controlled study; prevent; programs; quality assurance; racial and ethnic; racial diversity; recruit; response; vaccine trial; vector vaccine; viral transmission

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).

项目摘要 本补充提案概述了COVID-19预防网络（CoVPN）的科学议程 研究将在纽约大学VTEU进行。我们将参与实施新冠疫苗 疗效试验“一项在成人中进行的III期、随机、双盲、安慰剂对照、多中心研究， 确定AZD 1222（一种非复制型ChAdOx 1载体疫苗）的安全性、有效性和免疫原性， 为预防COVID-19而努力。”除了上述要求外，作为进一步处理 为了完成CoVPN的使命，我们正在为其他CoVPN研究和其他COVID相关研究申请资金。 我们计划在CoVPN -单克隆抗体（mAb）研究中进行额外研究：III期， 随机、双盲、安慰剂对照研究，评估抗SARS病毒的有效性和安全性- 冠状病毒2型单克隆抗体预防家庭接触者SARS冠状病毒2型感染 感染了SARS-CoV-2。 随着全球COVID-19大流行，我们认识到对修饰COVID-19的疫苗的巨大需求， SARS-CoV-2感染者。我们将进行的疫苗试验是第三阶段，安慰剂对照，双重- 一项双盲研究将测试AZD 1222（一种重组复制缺陷型黑猩猩腺病毒）的疗效 表达SARS-CoV-2刺突（S）表面糖蛋白，以改变18岁以下成年人的COVID-19疾病 年龄和老年人。参与者将从美国多达100个临床试验中心招募， 分析以针对具有不同种族和民族特征的高风险个体。 我们将进行的MAB研究是一项关键的III期随机、双盲、安慰剂对照研究， 家庭接触暴露于SARS-CoV-2感染者的成年人， 活跃的COVID-19疫情。理想的预防剂应该是快速作用和高度有效的，并且应该 防止多种病毒变种。一种单克隆抗体（mAb）联合治疗， 结合SARS-CoV-2刺突蛋白部分的不同区域的单克隆抗体，所述刺突蛋白结合 并促进进入宿主细胞，以实现这些目标。mAb组合 针对SARS-CoV-2的暴露后预防，可以预防疾病的发展， 减少病毒获得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。 我们还申请了研究中心准备资金，并为Mulligan博士作为另一个人与生物圈计划的国家主要研究者提供资金。 研究（礼来MAB在养老院居民和工作人员中用于COVID-19预防）。