Trials Sponsors Conditions Drugs Pricing

Conditions

Norovirus Infections

Outcome Measures

Primary Outcomes (5)

Rate of Solicited Symptoms of Reactogenicity
To assess the safety and tolerability of an oral tableted vaccine by collection of solicited symptoms of vaccine reactogenicity recorded daily using a subject diary card for 1 week post initial vaccination at Day 1.
Up to Day 8
To assess the induction of VP1-specific Immunoglobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay
Change from baseline in VP1-specific Immunogolobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay will be evaluated at Day 8
Change from baseline at Day 8
To assess histo-blood group antigen (HBGA) blocking antibodies by blockade titer (BT50)
Change from baseline in histo-blood group antigen (HBGA) blocking antibodies evaluated at Day 29
Change from baseline at Day 29
To assess VP1-specific serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay
Change from baseline in VP1-specific Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay will be evaluated at Day 29
Change from baseline at Day 29
To assess the VP1-specific serum Immunoglobin A (IgA) by Mesoscale Discovery (MSD) assay
Change from baseline in VP1-specific serum IgG by Mesoscale Discovery (MSD) will be evaluated at Day 29
Change from baseline at Day 29

Study Arms (1)

Cohort 1

EXPERIMENTAL

Single 1E11 dose administered via multiple sub-doses over a 4-hour period in adults (18-55 yrs).

Biological: VXA-G1.1-NN

Interventions

VXA-G1.1-NNBiological

Norovirus GI.1 Norwalk VP1 Vaccine (VXA-G1.1-NN) E1/E3-Deleted Replication-Defective Recombinant Adenovirus 5 with Adjuvant Oral Tablet Vaccine.

Also known as: Oral Tableted Ad5 Norovirus GI.1 Vaccine

Cohort 1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

to 55 years old, inclusive, at day of signing Informed Consent Form (ICF)
General good health, without significant uncontrolled medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the Research Monitor and Sponsor

Sponsors & Collaborators

Vaxart
Industrylead

Study Sites (1)

AltaSciences LA

Cypress, California, 90630, United States

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Study Officials

James Cummings, MD
Vaxart, Inc.
STUDY DIRECTOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Masking Details: Open Label
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 28, 2022

Study Start

January 24, 2022

Actual (reported)

A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (1)

Cohort 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (1)

Cohort 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations