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).

严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2)，冠状病毒的病原体 2019 年疾病 (COVID-19) 大流行，已感染全球超过 1.26 亿人，并导致超过 270 万人死亡，其中美国死亡人数超过 548,000 人（2021 年 3 月 27 日，世界卫生组织；www.who.int）。多种的 SARS-CoV-2 疫苗结构的 3 期功效试验正在进行或在美国进行长期随访， 这些研究支持了 3 项新冠疫苗紧急使用授权 (EUA)。这 变异菌株的出现引起了人们对免疫和保护范围的担忧 目前的疫苗。 WHO SAGE 和 CDC ACIP 已确定混合疫苗的安全性和免疫原性 时间表作为关键和直接的研究优先事项，为混合时间表的使用政策提供信息。 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 有机会彻底评估由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。本次1/2期临床试验将 评估不同异源延迟剂量（加强剂量）对以下患者的安全性和免疫原性 接受了 EUA 疫苗（在参与本试验之前或作为本试验的一部分）。