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

• 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
• 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

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：NOT-AI-20-034 FOA：PA-20-135 -现有NIH奖项的紧急竞争修订 活动代码/奖项：UM 1/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 复发，迫切需要继续开展在几项COVID-19疫苗有效性试验中开始的工作， 对选定人群进行必要的桥接研究，并继续研究SARS的免疫效应- CoV-2在不断变化的流行病格局中。由于其在实施全球艾滋病毒疫苗方面的经验， 有效性试验及其应对新的全球流行病的运营能力，HVTN已被选为 新成立的COVID-19预防网络（CoVPN）的疫苗运营中心。继续 这项工作始于2020年春季，在一系列大规模疗效试验中，该提案概述了四个具体的 支持基础设施能力所需的目标，以便在今后几个月继续开展这项工作： CoVPN疫苗运营中心，用于实施和管理COVID-19疫苗第3阶段 有效性和桥接试验，快速发布试验数据，在高危人群中建立外部关系网络， 并与媒体合作，宣传和促进正在进行的招生。该提案将确保74 美国的临床试验中心以及拉丁美洲和撒哈拉以南非洲的50多个试验中心完全 支持继续实施NIH支持的COVID-19疫苗有效性试验和桥接研究 计划明年实施。