Delving into the Latest Updates on VXA-G2-4-NS with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

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

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Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Norovirus Infections

Inactive Indication-

Originator Organization

Vaxart, Inc.

Active Organization

Vaxart, Inc.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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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.

Start Date28 Feb 2022

Sponsor / Collaborator

Vaxart, Inc.

NCT03897309

/ CompletedPhase 1

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.

Start Date20 Mar 2019

Sponsor / Collaborator

Vaxart, Inc.

100 Clinical Results associated with VXA-G2-4-NS

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100 Translational Medicine associated with VXA-G2-4-NS

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100 Patents (Medical) associated with VXA-G2-4-NS

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100 Deals associated with VXA-G2-4-NS

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