VXA-G2-4-NS(VXA-G2-4-NS) - 在研适应症：诺如病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

GII.4 oral vaccine tablet、Monovalent GII.4 tableted vaccine、Norovirus GII.4 vaccine

+ [3]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

诺如病毒感染

非在研适应症-

原研机构

Vaxart, Inc.

在研机构

Vaxart, Inc.

非在研机构-

最高研发阶段临床2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

2

项与 VXA-G2-4-NS 相关的临床试验

NCT05626803

/ Active, not recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.

This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

开始日期2022-02-28

申办/合作机构

Vaxart, Inc.

NCT03897309

/ Completed临床1期

A Ph 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 With Monovalent or Bivalent Dosing

VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for
4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group
4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.

开始日期2019-03-20

申办/合作机构

Vaxart, Inc.

100 项与 VXA-G2-4-NS 相关的临床结果

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100 项与 VXA-G2-4-NS 相关的专利（医药）

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100 项与 VXA-G2-4-NS 相关的药物交易

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