CoVPN LOC Cross-Protocol Infrastructure Supplement for GY15 and GY16

NOSI：不是-AI-20-034 FOA：PA-20-135-对现有NIH奖项的紧急竞争修订 活动代码/奖项：UM1/A1068614-15(家长奖) ---------------------------------- 项目摘要 鉴于SARS-CoV-2感染的快速传播、正在进行的全球大流行以及季节性流感的风险 复发迫切需要继续在几个新冠肺炎疫苗疗效试验中开始的工作，执行 为选定的人群进行必要的衔接研究，并继续研究SARS的免疫学影响- 不断演变的疫情格局中的CoV-2。由于其在实施全球艾滋病毒疫苗方面的经验 在药效试验及其应对新的全球大流行的业务能力方面，HVTN被选为 新成立的新冠肺炎预防网络(CoVPN)的疫苗运营中心。继续 在2020年春季开始的一系列大规模疗效试验中，这项建议概述了四个具体的 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：支持 新冠肺炎疫苗三期实施和管理协同VPN疫苗运营中心 疗效和桥梁试验，快速公布试验数据，在高危人群中建立外部关系网络， 并与媒体合作，为正在进行的招生做广告和推广。这项提议将确保74 美国的临床试验地点以及拉丁美洲和撒哈拉以南非洲的50多个试验地点完全 支持继续实施美国国立卫生研究院资助的新冠肺炎疫苗效力试验和衔接研究 计划在明年实施。

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.