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凯撒华盛顿疫苗和治疗提供资金 评估单位 (VTEU) 作为 DMID 研究 21-0012 的临床中心，这是一项 1/2 期延迟研究 接受 EUA 疫苗后进行异源 SARS-CoV-2 疫苗剂量（加强）。该临床试验将评估 接受 EUA 的患者中不同异源延迟剂量（加强剂量）的安全性和免疫原性 疫苗（在参与本试验之前，或作为本试验的一部分）。 自 20 世纪 60 年代以来，VTEU 就针对传染病开展了疫苗和候选治疗药物的试验。 具有公共卫生重要性的疾病（艾滋病毒除外），包括流感、疟疾、天花、 炭疽和肺炎球菌感染。自此以来，Kaiser Washington 作为 VTEU 站点持续获得资助 2007年和2019年作为新园区十个VTEU基地之一获得了为期七年的合作协议 成立 NIAID 传染病临床研究联盟 (IDCRC)。 2020 年，NIH 和 IDCRC 为应对 COVID-19 大流行，启动了第一个试验 (20-0003) 候选 COVID-19 疫苗 (mRNA-1273)，一种由 NIH 疫苗研究中心共同开发的 mRNA 疫苗 Center 和 Moderna, Inc，于 2020 年 3 月进行。Kaiser Washington VTEU 最初是该试验的唯一地点 后来在招生和地点方面进行了扩大，还包括埃默里大学学院 医学 VTEU 和 NIH 疫苗研究中心所在地。 mRNA-1273已获准紧急使用 获得授权的还有辉瑞公司的 mRNA 疫苗和杨森公司的腺病毒载体疫苗。 了解使用异源平台的加强疫苗的安全性、耐受性和免疫原性 EUA 初次给药​​后施用的同源或变异尖峰谱系是关键部分 为公共卫生决策提供信息所需的信息。异源增强策略还将提供 有机会彻底评估多种因素引起的先天、细胞和体液免疫反应 使用非常相似的免疫原、利用 mRNA、腺病毒载体和蛋白质来进行初免加强组合 为基础的平台。随着新疫苗针对新兴变种的生产，这些基础数据将成为关键 评估未来的变体和异源初免-加强策略。