CoVPN 3001 A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine SDMC

CoVPN 3001 评估 mRNA-1273 SARS-CoV-2 疫苗 SDMC 的功效、安全性和免疫原性的 3 期、随机、分层、观察者盲法、安慰剂对照研究

• 批准号: 10217912
• 负责人: Peter B. Gilbert
• 金额: $ 141.43万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-20 至 2021-07-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10217912
• 关键词: 18 year old; 2019-nCoV; Address; Adult; Age-Years; Biological Assay; Biometry; COVID-19; COVID-19 pandemic; COVID-19 vaccine; Cause of Death; Cellular Assay; Clinic; Clinical; Clinical Trials; Clinical Trials Network; Cohort Studies; Communicable Diseases; Communities; Data Analytics; Development; Diagnosis; Disease; Disease Outbreaks; Double-Blind Method; End Point Assay; Enrollment; Exposure to; Eye; Future; Goals; HIV Vaccine Trials Network; HIV vaccine; Health; Home environment; Hospitalization; Immune; Immune response; Immunity; Immunologic Monitoring; Immunology; Individual; Infection; Infection Control; Infection prevention; Injections; Intervention; Kinetics; Knowledge; Laboratories; Lead; Leadership; Lipids; Malaria; Meat; Mediating; Monitor; Morbidity - disease rate; Participant; Persons; Phase; Placebos; Plants; Population; Preparation; Prevention; Preventive; Proteins; Protocols documentation; Quality Control; RNA; Randomized; Randomized Clinical Trials; Research Methodology; Risk; Safety; Sampling; Serological; Severities; Site; System; Testing; Therapeutic Monoclonal Antibodies; Typhoid Fever; United States National Institutes of Health; Vaccines; Validation; Virus; Virus Diseases; adaptive immune response; base; blind; clinical trial analysis; design; efficacy study; efficacy testing; efficacy trial; experience; high risk; immune function; immunogenicity; improved; mortality; operation; placebo controlled study; prevent; programs; quality assurance; racial and ethnic; racial diversity; recruit; response; screening; vaccine trial

Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for implementation of the first COVID-19 vaccine efficacy trial “A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older.” With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. Addressing this gap, the HVTN has joined 4 other National Institute of Health (NIH) clinical trial networks to form the CoVPN, an enhanced network dedicated to developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience implementing HIV vaccine trials, the HIV Vaccine Trials Network (HVTN) LOC was selected to as the CoVPN vaccine LOC. This trial, a phase 3, placebo-controlled, double-blinded study will test the efficacy of mRNA-1273 SARS-CoV- 2, a lipid co-formulated messenger ribonucleic acid (mRNA) vaccine encoding the SARS-CoV-2 spike protein (S), to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from clinical trial sites across the US, using data analytics to target high risk individuals with a diverse racial and ethnic profile. In addition, the CoVPN will use accessory community-based sites, staffed by clinical teams from the home sites and employ mobile clinics to enroll individuals in new high risk settings (e.g., meat packing plants). Participants will receive symptomatic screening for SARS-CoV-2 infection, and if they become infected will be monitored with frequent clinical check-ins and remote monitoring of vital signs. Infected individuals who progress to moderate-severe COVID-19 will be referred for hospitalization. All trial endpoint assays will be done at CoVPN laboratories, using validated assays for diagnosis and immune monitoring. Specific aims of this study are to demonstrate efficacy of mRNA-1273 SARS-CoV-2 to prevent COVID-19, to evaluate the safety and reactogenicity of 2 injections given 28 days apart, the assess the ability to prevent infection with SARS-CoV-2, the assess the ability to modify COVID-19 infection, to evaluate viral infection kinetics, and to evaluate the vaccine induced immune response. This initial efficacy trial will tell us much about the adaptive immune response in persons who receive a SARS-CoV-2 S protein based vaccine and about their ability to modify the disease course of COVID-19. In addition, it will improve our understanding of the dynamics and duration of these responses and will inform rational design and testing of preventive and therapeutic monoclonal antibody interventions. Lastly, the results of this trial will be used to assess registration of this vaccine product as well as to modify future COVID-19 vaccine trials planned over the next 12 months.

项目摘要 该提案概述了 COVID-19 预防网络 (CoVPN) 疫苗的科学议程 领导运营中心 (LOC) 实施首个 COVID-19 疫苗功效试验“A 阶段” 3、随机、分层、观察者盲法、安慰剂对照研究，以评估疗效、安全性和 mRNA-1273 SARS-CoV-2 疫苗对 18 岁及以上成年人的免疫原性。” 随着全球 COVID-19 大流行，我们认识到对改变 COVID-19 的疫苗的巨大需求 为了解决这一差距，HVTN 加入了其他 4 个国家研究所的行列。 美国国立卫生研究院 (NIH) 临床试验网络组建 CoVPN，这是一个致力于全球发展的增强网络 凭借实施 HIV 疫苗试验的丰富经验，HIV 疫苗已成为针对 SARS-CoV-2 的有效疫苗。 疫苗试验网络 (HVTN) LOC 被选为 CoVPN 疫苗 LOC。 这项试验是一项 3 期、安慰剂对照、双盲研究，将测试 mRNA-1273 SARS-CoV- 的功效 2，一种脂质复合配方的信使核糖核酸（mRNA）疫苗，编码 SARS-CoV-2 刺突蛋白 (S)，为了改变 18 岁及以上成人的 COVID-19 疾病，将从临床招募参与者。 美国各地的试验地点，利用数据分析来针对不同种族和民族的高风险人群 此外，CoVPN 将使用基于社区的附属站点，由来自医疗机构的临床团队组成。 家庭地点并使用流动诊所来招募新的高风险环境中的个人（例如肉类包装厂）。 参与者将接受 SARS-CoV-2 感染症状筛查，如果被感染，将接受 通过频繁的临床检查和远程监测感染者的生命体征进行监测。 进展为中度至重度 COVID-19 将转送住院治疗。 在 CoVPN 实验室完成，使用经过验证的分析进行诊断和免疫监测。 本研究的具体目的是证明 mRNA-1273 SARS-CoV-2 预防 COVID-19 的功效，以 评估间隔 28 天进行 2 次注射的安全性和反应原性，评估预防的能力 感染 SARS-CoV-2、修改 COVID-19 感染的能力、评估病毒感染 动力学，并评估疫苗诱导的免疫反应，这一初步功效试验将告诉我们很多有关的信息。 接受基于 SARS-CoV-2 S 蛋白的疫苗的人的适应性免疫反应及其相关信息 此外，它将提高我们对疾病动态的了解。 以及这些反应的持续时间，并将为预防和治疗的合理设计和测试提供信息 最后，该试验的结果将用于评估该注册。 疫苗产品，并修改计划在未来 12 个月内进行的 COVID-19 疫苗试验。