CoVPN Vaccine Site Preparation

CoVPN 疫苗现场准备

• 批准号: 10187741
• 负责人: MYRON Scott COHEN
• 金额: $ 16958.77万
• 依托单位: FAMILY HEALTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-14 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10187741
• 关键词: 2019-nCoV; Administrative Supplement; Africa South of the Sahara; COVID-19; COVID-19 vaccine; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Diagnostic; Disease; Disease Management; Disease Outbreaks; Drug Industry; Enrollment; Ethics; Funding; HIV Vaccine Trials Network; Infection; Infrastructure; International; Measures; Monitor; Monoclonal Antibodies; Phase; Population; Preparation; Prevention; Public Health; Recurrence; Request for Applications; Risk; Series; Site; South America; Testing; Time; United States; United States National Institutes of Health; Vaccines; Work; clinical infrastructure; clinical research site; cost; efficacy trial; experience; health economics; high risk; human subject protection; implementation trial; pandemic disease; prevent; prevention efficacy trial; response; vaccine candidate

Project Summary/Abstract Given the rapid spread of SARS-CoV-2 infection, the on-going global pandemic, and the risk for seasonal recurrence there is a critical need to test emerging vaccine candidates in phase 3 efficacy trials. Due to its experience in implementation of global HIVAIDS prevention efficacy trials and its operational capacity to respond to a new global pandemic, the HPTN, in collaboration with the HVTN, is providing operational support for the newly constituted COVID-19 Prevention Network (CoVPN). Preparing for a series of large scale efficacy trials, this application outlines aims required to build the infrastructure capacity to rapidly implement them over the coming month. The requested funds are to prepare clinical trial sites for implementation of these trials. The HPTN will support 30 clinical trials sites in the United States, South America, and Sub-Saharan Africa so they can begin enrollment in NIH supported COVID-19 vaccine and monoclonal trials planned for implementation over the next 6 months.

项目总结/摘要 鉴于SARS-CoV-2感染的快速传播，正在进行的全球大流行，以及季节性 复发迫切需要在3期效力试验中测试新出现的候选疫苗。由于 开展全球艾滋病预防效果试验的经验和业务能力 为了应对新的全球流行病，HPTN与HVTN合作， 支持新成立的COVID-19预防网络（CoVPN）。准备一系列的 大规模疗效试验，该应用程序概述了建立基础设施能力所需的目标， 在接下来的一个月里迅速实施。申请的资金用于准备临床试验场地 进行这些试验。HPTN将支持美国的30个临床试验地点， 南美洲和撒哈拉以南非洲，以便他们能够开始招募NIH支持的COVID-19疫苗 以及计划在未来6个月内实施的单克隆试验。