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ND1.1

Phase 1

Avian Influenza | Biologics | Infectious Disease |Vaxart, Inc|Trials Updated: Dec 10, 2014

ND1.1 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Apr 2011

ND1.1 target and mechanism

ModalityBiologics

Also known as Ad-HA-dsRNA

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment66

FDA Designations

No designations recorded

ND1.1 clinical trials

ND1.1 · 2 trials · 2 indications

Phase 1 2
NCT01698060Immunogenicity of ND1.1 by Delivery Directly to the IleumAvian Influenza
COMPLETED12 Analytics
NCT01335347Safety Study of an Oral Vaccine to Prevent Avian InfluenzaAvian Influenza
COMPLETED54 Analytics
PHASE1COMPLETED
Immunogenicity of ND1.1 by Delivery Directly to the Ileum
Avian Influenza
NCT0169806012
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PHASE1COMPLETED
Safety Study of an Oral Vaccine to Prevent Avian Influenza
Avian Influenza
NCT0133534754
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Study Endpoints

Primary Endpoints

Safety
1 year

Frequency and magnitude of adverse events

Frequency or severity of vaccine related events as measured through reported AEs
up to 1 year

Secondary Endpoints

Immunogenicity
1 year
Magnitude of humoral immune responses to avian influenza as measured by functional assays
up to 1 year
Magnitude of cellular immune responses to avian influenza as measured by functional assays
up to 1 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Intestinal DeliveryEXPERIMENTALND1.1
Experimental Low DoseEXPERIMENTALBiological: One dose of a live replication incompetent adenovirus given in a capsule
Experimental Medium DoseEXPERIMENTALBiological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape
Experimental High DoseEXPERIMENTALBiological: One dose of replication incompetent adenovirus in a capsule
Placebo ControlPLACEBO_COMPARATORCapsules of the same size and shape as the experimental

Interventions

NameTypeDescription
ND1.1BIOLOGICAL -
Placebo controlBIOLOGICALCapsules of the same size and shape as experimental groups
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Eligibility Criteria

Age Range18 Years to 49 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Able and willing to complete informed consent * Healthy, as established by medical history, physical exam, and laboratory assessments * Has normal bowel movements * Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after di...

Countries:United States
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