CoVPN LOC Cross-Protocol Infrastructure Supplement for GY15 and GY16

适用于 GY15 和 GY16 的 CoVPN LOC 跨协议基础设施补充

基本信息

批准号：
10571201
负责人：
Dan H. Barouch
金额：
$ 532.4万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-30 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10571201
关键词：
2019-nCoV Africa Africa South of the Sahara Asia Award COVID-19 COVID-19 Prevention Network COVID-19 impact COVID-19 outbreak COVID-19 pandemic COVID-19 vaccine Clinic Clinical Clinical Trials Code Communities Community Health Data Diagnostic Disease Management Drug Industry Emergency Situation Enrollment Ensure Epidemic HIV Vaccine Trials Network HIV vaccine Immunocompromised Host Immunologics Information Dissemination Infrastructure International Laboratories Latin America Marketing Monitor Parents Persons Phase Population Protocols documentation Public Health Publishing Recurrence Risk SARS-CoV-2 infection Series Site Testing Therapeutic Time United States United States National Institutes of Health Vaccines Work clinical research site efficacy trial experience health economics high risk high risk population improved operation pandemic disease vaccine candidate

项目摘要

NOSI: NOT-AI-20-034 FOA: PA-20-135 – Emergency Competitive Revision to Existing NIH Awards Activity Code/Award: UM1/A1068614-15 (parent award) ------------------------------------------------------------------------------------ Project 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 continue work begun in several COVID-19 vaccine efficacy trials, perform necessary bridging studies for select populations, and continue to study the immunological effects of SARS- CoV-2 in an evolving epidemic landscape. Due to its experience in implementation of global HIV vaccine efficacy trials and its operational capacity to respond to a new global pandemic, the HVTN has been chosen as the vaccine operations center for the newly constituted COVID-19 Prevention Network (CoVPN). Continuing work begun in the spring of 2020 in a series of large scale efficacy trials, this proposal outlines four specific aims required to support the infrastructural capacity to continue this work over the coming months: to support the CoVPN vaccine operations center for implementation and management of COVID-19 vaccine phase 3 efficacy and bridging trials, to rapidly publish trial data, to build external relations networks in high-risk groups, and to work with media outlets to advertise and promote ongoing enrollment. This proposal will ensure that 74 clinical trials sites in the United States and over 50 trial sites in Latin America and Sub-Saharan Africa are fully support in continuing implementation of NIH supported COVID-19 vaccine efficacy trials and bridging studies planned for implementation over the next year.

NOSI：不是-AI-20-034 FOA：PA-20-135 – 对现有 NIH 奖项的紧急竞争性修订活动代码/奖项：UM1/A1068614-15（家长奖） -------------------------------------------------- ---------------------------------- 项目摘要鉴于 SARS-CoV-2 感染的迅速传播、持续的全球大流行以及季节性流感的风险复发迫切需要继续开展几项 COVID-19 疫苗功效试验中开始的工作，执行对特定人群进行必要的桥接研究，并继续研究 SARS 的免疫学影响由于其在实施全球艾滋病毒疫苗方面的经验，冠状病毒（CoV-2）处于不断变化的流行病格局中。 HVTN 被选为功效试验及其应对新的全球大流行的运作能力新成立的 COVID-19 预防网络 (CoVPN) 的疫苗运营中心。该提案于 2020 年春季开始进行一系列大规模功效试验，该提案概述了四个具体内容支持基础设施能力以在未来几个月继续这项工作所需的目标： CoVPN 疫苗运营中心，负责实施和管理 COVID-19 疫苗第 3 阶段功效和桥接试验，快速发布试验数据，在高危人群中建立外部网络关系，并与媒体合作宣传和促进持续招生。74 美国的临床试验中心以及拉丁美洲和撒哈拉以南非洲地区的 50 多个试验中心已全面启动支持继续实施 NIH 支持的 COVID-19 疫苗功效试验和桥接研究计划于明年实施。