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 该提案概述了新冠肺炎预防网络疫苗的科学议程 统计和数据管理中心(SDMC)，执行跨协议工作，以支持 新冠肺炎三期疗效试验。 由于全球新冠肺炎大流行，非常需要一种预防性的SARS-CoV-2疫苗。 为了弥补这一差距，HVTN加入了其他4个国家卫生研究所(NIH)的临床试验网络，以 成立CoVPN，这是一个增强的网络，致力于开发全球有效的SARS-CoV-2疫苗。 CoVPN统计中心在所有CoVPN COVID疫苗试验的方案开发方面进行跨研究 并负责确保试验过程中数据和方法的统一。因此，我们有很好的 洞察试验终点与其测量、基线之间的可比性 特征，以及研究人群。此外，CoVPN统计中心将其独特的资源 我们小组的背景和专业知识：我们在疫苗评估的统计方法方面处于领先地位， 尤其是对免疫相关指标的评估。我们的工作得益于我们长期而深入的合作 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级的实验室、生物统计学和疫苗试验 使用尖端跨协议评估新冠肺炎疫苗诱导的应答的领导专业知识 评估疫苗效力、疫苗安全信号、感染和疾病发生率的统计方法， 和免疫学上的保护性关联。