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.

此补充资金申请申请为Kaiser Washington疫苗和治疗提供资金 评估单元(VTEU)将作为DMID研究21-0012的临床站点，延迟的1/2期研究 接受EUA疫苗后的异种SARS-CoV-2疫苗剂量(Boost)。这项临床试验将评估 不同异种延迟剂量(增强)在接受EUA患者中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一直在进行传染病疫苗和治疗候选药物的试验 对公共卫生具有重要意义的疾病(艾滋病毒除外)，包括例如流感、疟疾、天花、 炭疽病和肺炎球菌感染。自那以后，凯撒·华盛顿作为VTEU地点一直得到资助 2007年，并于2019年作为新的VTEU十个地点之一获得了一份为期七年的合作协议 成立了NIAID传染病临床研究联盟(IDCRC)。 2020年，美国国立卫生研究院和国际疾病控制与预防中心为应对新冠肺炎大流行，启动了首个试验(20003) 美国国立卫生研究院疫苗研究中心联合开发的新冠肺炎候选疫苗 Center和Modelna，Inc.，2020年3月。德皇华盛顿VTEU最初是那次审判的唯一地点 它后来在招生和地点方面进行了扩大，也包括埃默里大学学院 医学VTEU和美国国立卫生研究院疫苗研究中心网站。MRNA-1273已被批准紧急使用 授权，AS有来自辉瑞的mRNA疫苗和来自Janssen的腺病毒载体疫苗。 使用异源平台的增强疫苗的安全性、耐受性和免疫原性的知识 在EUA一次给药后给药的同源或变异的棘波谱系是 为公共卫生决策提供信息所需的信息。异源助推策略还将提供 彻底评估先天、细胞和体液免疫反应的机会 Prime Boost组合使用非常相似的免疫原，利用mRNA、腺病毒载体和蛋白质- 基于平台的。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 对未来变种和异种质数-升压策略的评估。