Vaccine and Treatment Evaluation Units (VTEU)

疫苗和治疗评估单位 (VTEU)

• 批准号: 10296949
• 负责人: HANA M EL SAHLY
• 金额: $ 261.48万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-23 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10296949
• 关键词: 18 year old; 2019-nCoV; Adjuvant; Adult; COVID-19; Evaluation; Location; Novavax COVID-19 vaccine; Participant; Phase; Proteins; Randomized; Recombinants; Recording of previous events; Risk; SARS-CoV-2 infection; Safety; Vaccine Clinical Trial; Vaccines; blind; efficacy evaluation; immunogenicity; nanoparticle; placebo controlled study

ABSTRACT This supplement request is for a Phase 3, randomized, observer-blind, placebo-controlled study to evaluate the efficacy, safety and immunogenicity, of a SARS-CoV-2 recombinant spoke protein nanoparticle vaccine (SARS-CoV-2 rS) with Matric-M1TM adjuvant in adult participants over 18 years of age who have no known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection. This request also relates to other COVID 19 activities.

抽象的 此补充请求适用于第 3 阶段、随机、观察者盲法、安慰剂对照研究 评估 SARS-CoV-2 重组辐条的功效、安全性和免疫原性 成人参与者使用 Matric-M1TM 佐剂的蛋白质纳米颗粒疫苗 (SARS-CoV-2 rS) 年满 18 岁，没有已知的 SARS-CoV-2 感染史，但其所在位置 或情况使他们面临感染 COVID-19 和/或 SARS-CoV-2 的明显风险 感染。此请求还涉及其他 COVID 19 活动。