SWIM-816(SWIM-816) - 在研适应症：新型冠状病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗、mRNA疫苗

别名

SWIM 816、SWIM816

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症

新型冠状病毒感染

非在研适应症-

原研机构

斯微（上海）生物科技股份有限公司初创企业

在研机构

斯微（上海）生物科技股份有限公司初创企业

非在研机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

1

项与 SWIM-816 相关的临床试验

NCT05911087 / Not yet recruiting临床2/3期

A Phase 2/3, Randomized, Double-blinded , Parallel Controlled Trial to Evaluate the Immunogenicity, Safety and Efficacy of A Heterologous Booster Dose With COVID-19 mRNA Vaccines (Bivalent) , in Previously Vaccinated Subjects Against COVID-19 With 2/3 Doses COVID-19 Vaccine Compared to a Booster Dose With mRNA COVID-19 Vaccine（Pfizer Bivalent Vaccine）in Adults.

Primary Immunogenicity Objective：Cohort 1: GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.Cohort 2: To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers (GMT) of COVID-19 mRNA vaccine(SWIM816) compare with mRNA COVID-19 vaccine(Pfizer Bivalent vaccine) 14 days post dose.
Primary Safety Objective：To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 doses of COVID-19 vaccine with or without previously diagnosed with COVID-19.
Secondary Immunogenicity Objectives：To describe the neutralizing antibody response at D29, D91 and D181.To describe binding antibody profile at D01, D15, D29, D91 and D181 of each study group.
Secondary Safety Objective：To assess the reactogenicity and safety of third or fourth booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 COVID-19 vaccine doses.
Exploratory Objective：1.Documented confirmed SARS-CoV-2 symptomatic infection；2.Todemonstrate the cellular immune response profile at study group (30 subjects per each group for cellular immune testing).

开始日期2023-06-20

申办/合作机构