CoVPN Cross-Protocol Analyses

CoVPN 跨协议分析

• 批准号: 10247368
• 负责人: Peter B. Gilbert
• 金额: $ 136.73万
• 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: 2020-11-13 至 2021-07-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247368
• 关键词: Address; Antibodies; Biometry; COVID-19; COVID-19 Prevention Network; COVID-19 outbreak; COVID-19 pandemic; COVID-19 vaccine; Characteristics; Clinical; Clinical Trials Network; Disease; Enrollment; Ensure; HIV Vaccine Trials Network; Health; Immune; Immune response; Immunity; Immunologics; Incidence; Individual; Infection; Laboratories; Lead; Leadership; Measurement; Mediator of activation protein; Methods; Modeling; Monitor; Participant; Periodicity; Phase; Population; Protocols documentation; Reporting; Reproducibility; Resources; Risk; SARS-CoV-2 infection; Signal Transduction; Site; Standardization; Statistical Methods; United States National Institutes of Health; Ursidae Family; Vaccination; Vaccines; Work; base; cohort; computer code; coronavirus disease; data harmonization; data management; design; efficacy trial; epidemiological model; immunogenicity; improved; insight; protocol development; recruit; response; statistical center; study population; tool; vaccine efficacy; vaccine evaluation; vaccine safety; vaccine trial

Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Statistical and Data Management Center (SDMC) for implementation of cross-protocol work in support of COVID-19 phase 3 efficacy trials. Due to the global COVID-19 pandemic, there is a significant need for a preventative SARS-CoV-2 vaccine. 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. The CoVPN Statistical Center works across studies in protocol development for all CoVPN COVID vaccine trials and bears responsibility for ensuring harmonization of data and methods across trials. Thus, we have great insight into the comparability between trials with respect to endpoints and their measurement, baseline characteristics, and study populations. Additionally, the CoVPN Statistical Center brings its unique resources in terms of the background and expertise of our group: we are leaders in statistical methods in vaccine evaluation, especially for immune correlates assessment. Our work is informed by our long-standing and deep collaborative relationships with the clinical and lab groups in the CoVPN. In this study, the CoVPN Statistical Center will apply its world class laboratory, biostatistical and vaccine trial leadership expertise to assess COVID-19 vaccine-induced responses using cutting-edge cross-protocol statistical methods for evaluating vaccine efficacy, vaccine safety signals, incidence of infection and disease, and immunological correlates of protection.

项目摘要 该提案概述了 COVID-19 预防网络 (CoVPN) 疫苗的科学议程 统计和数据管理中心（SDMC），用于实施跨协议工作以支持 COVID-19 3 期疗效试验。 由于全球 COVID-19 大流行，非常需要预防性 SARS-CoV-2 疫苗。 为了解决这一差距，HVTN 加入了另外 4 个美国国立卫生研究院 (NIH) 临床试验网络，以 组建 CoVPN，这是一个致力于开发全球有效的 SARS-CoV-2 疫苗的增强网络。 CoVPN 统计中心致力于所有 CoVPN COVID 疫苗试验的方案开发研究 并负责确保试验中数据和方法的统一。因此，我们有伟大的 深入了解试验之间关于终点及其测量、基线的可比性 特征和研究人群。此外，CoVPN统计中心还带来了其独特的资源 就我们团队的背景和专业知识而言：我们是疫苗评估统计方法的领导者， 特别是对于免疫相关评估。我们的工作源于我们长期深入的合作 与 CoVPN 中的临床和实验室小组的关系。 在这项研究中，CoVPN统计中心将应用其世界一流的实验室、生物统计和疫苗试验 使用尖端跨协议评估 COVID-19 疫苗引起的反应的领导专业知识 用于评估疫苗功效、疫苗安全信号、感染和疾病发生率的统计方法， 和保护的免疫相关性。