Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site:21-0011

实施疫苗和治疗评估单位 (VTEU) 临床站点：21-0011

• 批准号: 10414457
• 负责人: Karen L. Kotloff
• 金额: $ 1166.99万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-11 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414457
• 关键词: 2019-nCoV; Address; Adjuvant; Adolescent; Adult; Ancillary Study; Blinded; COVID-19; COVID-19 pandemic; COVID-19 vaccine; Childhood; Dose; Evaluation; Goals; Health; Individual; Infection; Investigation; Knowledge; Measures; Novavax COVID-19 vaccine; Outcome; Participant; Phase; Placebos; Population; Proteins; Proxy; Randomized; Recombinants; Reverse Transcriptase Polymerase Chain Reaction; Risk; SARS-CoV-2 infection; Safety; Swab; Testing; Vaccines; Viral Load result; clinical research site; clinically significant; efficacy evaluation; immunogenicity; nanoparticle; novel strategies; placebo controlled study; symptomatology; transmission process; vaccine efficacy; vaccine trial

Project Summary The primary goal of current COVID-19 vaccine trials is to measure vaccine efficacy (VE) against clinically significant infection. However, on a population level, vaccine efficacy against all infection, including asymptomatic or very mildly symptomatic infection, is an important endpoint. This proposal outlines an ancillary swab study to the Novavax Phase 3 SARS-CoV-2 vaccine trial (PREVENT-19) to address these knowledge gaps. With the global SARS-CoV-2 pandemic, we recognize a significant need for vaccines that not only modify COVID-19 in SARS-CoV-2 infected individuals but also reduce infection/transmission regardless of symptomatology. In this study, participants will self-swab twice weekly starting at or shortly after their second dose of either SARS-CoV-2 rS/M1 or placebo. These swabs will be tested for SARS-CoV-2 by RT-PCR. Specific Aims of this study are to estimate the efficacy of SARS-CoV-2 rS/M1 vaccine against infection, to estimate the efficacy of SARS-CoV-2 rS/M1 vaccine against asymptomatic/very mildly symptomatic infection, to determine the sequence of breakthrough SARS-CoV-2 infections, to estimate the vaccine efficacy on duration of infection, to estimate the vaccine efficacy against SARS-CoV-2 viral load as a proxy of transmission, and to explore whether observed vaccine efficacy against COVID-19 illness reflects a transition from symptomatic into asymptomatic infections versus an absolute reduction in all SARS-CoV-2 infections. This ancillary swab study will tell us much about the ability of SARS-CoV-2 rS/M1 to reduce infection regardless of symptomatology. In addition, it will provide important information on the ability of the vaccine to reduce duration of infection and transmission.

项目摘要 当前COVID-19疫苗试验的主要目标是测量疫苗对临床 严重感染。然而，在人群水平上，疫苗对所有感染的效力，包括 无症状或症状非常轻微的感染是一个重要的终点。该提案概述了一个辅助 诺华3期SARS-CoV-2疫苗试验（PREVENT-19）的拭子研究，以解决这些知识 差距。 随着全球SARS-CoV-2大流行，我们认识到对疫苗的巨大需求， COVID-19在SARS-CoV-2感染者中的作用，但无论 医学。在这项研究中，参与者将在第二次或第二次之后不久开始每周自我擦拭两次。 剂量的SARS-CoV-2 rS/M1或安慰剂。这些拭子将通过RT-PCR检测SARS-CoV-2。 本研究的具体目的是评估SARS-CoV-2 rS/M1疫苗抗感染的有效性， 评估SARS-CoV-2 rS/M1疫苗对无症状/极轻度症状感染的有效性， 确定突破性SARS-CoV-2感染的顺序，以估计疫苗在持续时间上的效力 的感染，以估计疫苗对SARS-CoV-2病毒载量的有效性作为传播的代理，并 探索观察到的疫苗对COVID-19疾病的有效性是否反映了从症状性转变为 无症状感染与所有SARS-CoV-2感染的绝对减少。 这项辅助拭子研究将告诉我们SARS-CoV-2 rS/M1减少感染的能力， 的医学。此外，它还将提供有关疫苗减少持续时间能力的重要信息 感染和传播。