Trials Sponsors Conditions Drugs Pricing

Conditions

Norovirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

Evaluate the safety of different dosing regimens of VXA-G1.1-NN vaccine as determined by the incidence of treatment-emergent adverse events, physical exams, vital signs, and clinical laboratory test results (hematology, serum chemistry, and urinalysis).
Safety will be evaluated by local and systemic reactogenicity (solicited symptoms), and clinical and laboratory assessments including physical exams, vital signs, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and adverse events (AEs).
Day 1 thru Day 57

Secondary Outcomes (1)

Evaluate the effect of different dosing regimens of VXA-G1.1-NN vaccine on its immunogenicity as determined by cellular and humoral immune function assays performed on blood samples collected at preselected study visits.
Day 1 thru Day 180

Study Arms (4)

Dose Group 1

EXPERIMENTAL

Multiple doses of low dose VXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1 and 8

Biological: VXA-G1.1-NN Oral Vaccine

Dose Group 2

EXPERIMENTAL

Multiple doses of low doseVXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1, 3, and 5

Biological: VXA-G1.1-NN Oral Vaccine

Interventions

VXA-G1.1-NN Oral VaccineBiological

The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high total doses.

Also known as: Active VXA-G.1.1-NN Oral Tablet Vaccine

Dose Group 1Dose Group 2Dose Group 3Dose Group 4

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

Eligibility Criteria

Age19 Years - 49 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female volunteers aged 19 - 49 years
Able to give written informed consent.

Sponsors & Collaborators

Vaxart
Industrylead

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Study Officials

Laura Sterling, MD
Celerion
PRINCIPAL INVESTIGATOR

Enrollment

66 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 24, 2017

Study Start

April 7, 2017

Actual (reported)

Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Dose Group 1

Dose Group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Dose Group 3

Dose Group 4

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Dose Group 1

Dose Group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Dose Group 3

Dose Group 4

You may not qualify if:

Source record

Locations