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VXA-RSV-f

Phase 1

Respiratory Syncytial Virus (RSV) | Biologics | Infectious Disease |Vaxart, Inc|Trials Updated: Aug 16, 2018

VXA-RSV-f target and mechanism

ModalityBiologics

Also known as VXA-RSV-f Tablets (high dose)

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-RSV-f clinical trials

VXA-RSV-f · 1 trial · 1 indication

Phase 1 1
NCT02830932Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)Respiratory Syncytial Virus (RSV)
COMPLETED66 Analytics
PHASE1COMPLETED
Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)
Respiratory Syncytial Virus (RSV)
NCT0283093266
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Study Endpoints

Primary Endpoints

Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.
Day 7

Number of Patients with Systemic Reactogenicity Symptoms

Secondary Endpoints

Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.
Day 28
Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMT)
Days 7 and 28
Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMFR)
Days 7 and 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VXA-RSV-f Tablets (high dose)EXPERIMENTALSinge dose of orally administered VXA-RSV-f Tablets (high dose). VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.
VXA-RSV-f Tablets (low dose)EXPERIMENTALSinge dose of VXA-RSV-f Tablets (low dose).VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.
VXA Placebo TabletsPLACEBO_COMPARATORSinge dose of matching placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered.

Interventions

NameTypeDescription
VXA-RSV-f Tablets (high dose)BIOLOGICALThe drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the high dose.
VXA Placebo TabletsOTHERThe placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
VXA-RSV-f Tablets (low dose)BIOLOGICALThe drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the low dose
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female volunteers aged 18 - 49 years, inclusive 2. Able to give written informed consent 3. Healthy (no clinically significant health concerns) 4. Safety laboratory values within the following range criteria normal range 5. Body mass index between 17 and 35 at screeni...

Countries:United States
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