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.

项目总结