Kaiser Washington Vaccine and Treatment Evaluation Unit - DMID 21-0012

凯撒华盛顿疫苗和治疗评估单位 - DMID 21-0012

• 批准号: 10414676
• 负责人: LISA A JACKSON
• 金额: $ 201.46万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-12 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10414676
• 关键词: Adenovirus Vector; Anthrax disease; Antigens; Award; COVID-19 pandemic; COVID-19 vaccine; Clinical Research; Clinical Trials; Communicable Diseases; Conduct Clinical Trials; Data; Diagnostic; Dose; Emerging Communicable Diseases; Enrollment; Evaluation; FDA Emergency Use Authorization; Foundations; Funding; Future; Grant; HIV; Immune response; Influenza; Knowledge; Malaria; Messenger RNA; Moderna COVID-19 vaccine; NIH Vaccine Research Center; National Institute of Allergy and Infectious Disease; Persons; Phase; Pneumococcal Infections; Proteins; Protocols documentation; Public Health; RNA vaccine; Request for Applications; Safety; Series; Site; Smallpox; Therapeutic; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Vaccines; Variant; Washington; base; clinical research site; immunogenicity; medical schools; novel vaccines; research study; therapeutic candidate; vaccine candidate; vaccine trial; vector vaccine

This Supplemental Funding application requests funding for the Kaiser Washington Vaccine and Treatment Evaluation Unit (VTEU) to function as a clinical site for DMID study 21-0012, a Phase 1/2 study of delayed heterologous SARS-CoV-2 vaccine dosing (boost) after receipt of EUA vaccines. This clinical trial will evaluate the safety and immunogenicity of different heterologous delayed doses (boosts) in those who received an EUA vaccine (either prior to participation in this trial, or as part of this trial). Since the 1960s the VTEUs have conducted trials of vaccines and therapeutic candidates for infectious diseases of public health importance (other than HIV) including, for example, influenza, malaria, smallpox, anthrax, and pneumococcal infection. Kaiser Washington has been continuously funded as a VTEU site since 2007, and in 2019 was awarded a seven-year cooperative agreement as one of ten VTEU sites in the newly formed NIAID Infectious Diseases Clinical Research Consortium (IDCRC). In 2020, the NIH and the IDCRC responded to the COVID-19 pandemic by launching the first trial (20-0003) of a candidate COVID-19 vaccine (mRNA-1273), an mRNA vaccine co-developed by the NIH Vaccine Research Center and Moderna, Inc, in March 2020. The Kaiser Washington VTEU was originally the sole site for that trial which was later expanded in terms of enrollment and sites, to also include the Emory University School of Medicine VTEU and the NIH Vaccine Research Center sites. mRNA-1273 has been granted Emergency Use Authorization, as has an mRNA vaccine from Pfizer and an adenovirus-vectored vaccine from Janssen. Knowledge of the safety, tolerability, and immunogenicity of a boost vaccine using a heterologous platform with the homologous or variant spike lineage administered after an EUA primary dosing is a critical piece of information needed to inform public health decisions. The heterologous boost strategy will also provide an opportunity to thoroughly evaluate innate, cellular, and humoral immune responses elicited from the multiple prime boost combinations using very similar immunogens, utilizing mRNA, adenovirus- vectored, and protein- based platforms. As new vaccines are manufactured to emerging variants, these foundational data will be key to the evaluation of future variant and heterologous prime-boost strategies.

此补充资金申请要求为Kaiser Washington疫苗和治疗提供资金 评估单元（VTEU）充当DMID研究的临床部位21-0012，延迟的1/2阶段研究 接收EUA疫苗后，异源SARS-COV-2疫苗给药（增强）。该临床试验将评估 那些接受EUA的人的不同异源延迟剂量（增强）的安全性和免疫原性 疫苗（在参加本试验之前，或作为本试验的一部分）。 自1960年代以来，VTEU进行了疫苗和治疗候选的试验 公共健康重要性疾病（艾滋病毒以外），包括流感，疟疾，天花， 炭疽和肺炎球菌感染。自从Kaiser Washington自从以来一直被作为VTEU地点提供资金 2007年，并在2019年被授予一项为期7年的合作协议，作为新的十个VTEU网站之一 形成的NIAID传染病临床研究联盟（IDCRC）。 2020年，NIH和IDCRC通过启动首次审判（20-0003）来回应Covid-19的大流行 候选Covid-19疫苗（mRNA-1273），一种由NIH疫苗研究共发育的mRNA疫苗 Center and Moderna，Inc，2020年3月。凯瑟·华盛顿VTEU最初是该试验的唯一场所 后来在入学和站点方面进行了扩展，还包括埃默里大学学校 Medicine VTEU和NIH疫苗研究中心地点。 mRNA-1273已被授予紧急使用 授权，来自辉瑞公司的mRNA疫苗和詹森的腺病毒载体疫苗。 了解使用异源平台的增强疫苗的安全性，耐受性和免疫原性的了解 EUA初级剂量后施用的同源或变体尖峰谱系是关键的一部分 为公共卫生决定提供信息所需的信息。异源提升策略还将提供 有机会彻底评估来自多重的先天，细胞和体液免疫反应的机会 使用非常相似的免疫原子，使用mRNA，腺病毒和蛋白质 - 基于平台。由于新的疫苗被制造为新兴变体，因此这些基础数据将是关键 评估未来的变体和异源的促进策略。