CoVPN Cross-Protocol Analyses

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），用于实施跨方案工作，以支持 COVID-19 3期疗效试验。 由于全球COVID-19大流行，对预防性SARS-CoV-2疫苗的需求非常大。 为了解决这一差距，HVTN加入了其他4个国家卫生研究所（NIH）临床试验网络， CoVPN是一个致力于开发全球有效的SARS-CoV-2疫苗的增强型网络。 CoVPN统计中心在所有CoVPN COVID疫苗试验的方案开发中开展研究 并负责确保试验间数据和方法的协调。因此，我们有很大的 深入了解试验之间在终点及其测量、基线 特征和研究人群。此外，CoVPN统计中心将其独特的资源 就我们小组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， 特别是用于免疫相关性评估。我们的工作得益于我们长期深入的合作， 与CoVPN中的临床和实验室组的关系。 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 领导专业知识，使用尖端的跨协议评估COVID-19疫苗诱导的反应 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， 和免疫相关的保护。

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.