University of Washington Vaccine and Treatment Evaluation Unit - DMID 21-0012

华盛顿大学疫苗和治疗评估单位 - DMID 21-0012

• 批准号: 10410301
• 负责人: Raymond Scott McClelland
• 金额: $ 125.93万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-24 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10410301
• 关键词: 2019-nCoV; Adenovirus Vector; Adult; Antigens; COVID-19; COVID-19 pandemic; COVID-19 vaccine; Centers for Disease Control and Prevention (U.S.); Cessation of life; Data; Dose; Evaluation; FDA Emergency Use Authorization; Foundations; Future; Immune response; Immunity; Knowledge; Longterm Follow-up; Messenger RNA; Multi-Institutional Clinical Trial; Phase; Phase I/II Clinical Trial; Policies; Proteins; Public Health; Research Priority; Safety; Schedule; United States; Universities; Vaccines; Variant; Washington; base; coronavirus disease; efficacy trial; immunogenicity; novel vaccines; open label

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), causative agent of the coronavirus disease of 2019 (COVID-19) pandemic, has infected over 126 million people worldwide and resulted in over 2.7 million deaths, including > 548,000 in the United States (March 27, 2021, WHO; www.who.int). Multiple Phase 3 efficacy trials of SARS-CoV-2 vaccine constructs are underway or in long-term follow-up in the U.S, and these studies have supported 3 Emergency Use Authorizations (EUAs) for COVID vaccines. The emergence of variant strains has raised concerns about the breadth of immunity and protection achieved by the current vaccines. WHO SAGE and CDC ACIP have identified the safety and immunogenicity of mixed schedules as a critical and immediate research priority to inform policy on the use of mixed schedules. 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. This phase 1/2 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).

严重急性呼吸综合征冠状病毒2型，冠状病毒的病原体 2019年疾病(新冠肺炎)大流行，已感染全球1.26亿人，导致 270万人死亡，其中包括美国的54.8万人(2021年3月27日，世卫组织；www.hor.int)。多重 美国正在进行SARS-CoV-2疫苗结构的第三阶段疗效试验或进行长期随访， 这些研究支持了COVID疫苗的3项紧急使用授权(EUA)。这个 变异株的出现引起了人们对以下病毒实现的免疫和保护的广泛关注 目前的疫苗。WHO SAGE和CDC ACIP已经确定了混合疫苗的安全性和免疫原性 将时间表作为一个关键和直接的研究优先事项，以便向政策通报混合时间表的使用情况。 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。这项1/2期临床试验将 评估不同异种延迟剂量(加强)在以下人群中的安全性和免疫原性 接种EUA疫苗(参加本试验之前或作为本试验的一部分)。