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VXA-GI.1.NN

Phase 1

Norovirus Infections | Biologics | Other |Vaxart, Inc|Trials Updated: Feb 13, 2023

VXA-GI.1.NN development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

VXA-GI.1.NN clinical trials

VXA-GI.1.NN · 1 trial · 1 indication

Phase 1 1
NCT04854746Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus VaccineNorovirus Infections
COMPLETED66 Analytics
PHASE1COMPLETED
Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine
Norovirus Infections
NCT0485474666
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Study Endpoints

Primary Endpoints

Rate of Solicited Adverse Events
Day 1 (Vaccination) to 7 days post vaccination

Safety

Rate of Unsolicited Adverse Events
Day 1 (Vaccination) to 28 days post vaccination

Safety

Secondary Endpoints

VP1 specific IgA ASC
Day 1 (Vaccination) to 7 days post vaccination
Norovirus GI.1 histo-blood group antigen GBGA blocking antibodies (BT50)
Day 1 (Vaccination) to 7 days post vaccination
VP1 specific serum IgG
Day 1 (Vaccination) to 7 days post vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Cohort 1 Low Dose ActiveACTIVE_COMPARATORVXA-GI.1-NN tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log10
Cohort 3 High Dose ActiveACTIVE_COMPARATORVXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log11
Cohort 1 Low Dose PlaceboPLACEBO_COMPARATORPlacebo tablets matching in number and appearance to active vaccine doses.
Cohort 3 High Dose PlaceboPLACEBO_COMPARATORPlacebo tablets matching in number and appearance to active vaccine doses.
Cohort 2 Medium Dose ActiveACTIVE_COMPARATORVXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 3x10Log10
Cohort 2 Medium Dose PlaceboPLACEBO_COMPARATORPlacebo tablets matching in number and appearance to active vaccine doses.

Interventions

NameTypeDescription
VXA-GI.1.NNBIOLOGICALGI.1 oral vaccine tablet
Placebo TabletBIOLOGICALTablets matching in number and appearance to active vaccine tablets
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Eligibility Criteria

Age Range55 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria To be eligible for this study, participants must meet all the following: Age 1. 55 to 80 years old inclusive at the time of signing the Informed Consent Form (ICF). Type of Participants 2. In stable and good general health, without significant medical illness, based on medi...

Countries:United States
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