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

本补充资金申请要求为凯撒华盛顿疫苗和治疗提供资金 评价单位（VTEU）将作为DMID研究21-0012的临床研究中心，DMID研究21-0012是一项延迟的I/II期研究， 接受EUA疫苗后给予异源SARS-CoV-2疫苗（加强）。这项临床试验将评估 在接受EUA的患者中，不同异源延迟剂量（加强）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已经进行了感染性疾病疫苗和治疗候选物的试验。 对公共卫生有重要意义的疾病（艾滋病毒除外），包括流感、疟疾、天花、 炭疽和肺炎球菌感染自年以来，凯撒华盛顿一直作为VTEU站点获得资助。 2007年，并于2019年被授予为期七年的合作协议，成为新的十个VTEU站点之一 NIAID传染病临床研究联盟（IDCRC） 2020年，美国国立卫生研究院（NIH）和IDCRC为应对COVID-19疫情，启动了第一项试验（20-0003）， 一种候选COVID-19疫苗（mRNA-1273），由NIH疫苗研究所共同开发的mRNA疫苗 中心和Moderna，Inc，于2020年3月。凯撒华盛顿VTEU最初是该试验的唯一地点 后来在招生和地点方面扩大，也包括埃默里大学学院， Medicine VTEU和NIH疫苗研究中心。mRNA-1273已被批准紧急使用 辉瑞公司的mRNA疫苗和杨森公司的腺病毒载体疫苗都获得了授权。 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， 在EUA初次给药后给予的同源或变体加标谱系是 为公共卫生决策提供所需信息。异源加强策略还将提供一种免疫抑制剂。 有机会彻底评估先天性，细胞和体液免疫反应引起的多重 使用非常相似的免疫原，利用mRNA，腺病毒载体和蛋白质， 基于平台。随着新疫苗的生产出现变异，这些基础数据将是关键 对未来变体和异源初免-加强策略的评估。

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.