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VXA-CoV2-1

Phase 1

Covid19 | Biologics | Infectious Disease |Vaxart, Inc|Trials Updated: Jun 21, 2024

VXA-CoV2-1 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

VXA-CoV2-1 clinical trials

VXA-CoV2-1 · 1 trial · 1 indication

Phase 1 1
NCT04563702Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of SubjectsCovid19
COMPLETED35 Analytics
PHASE1COMPLETED
Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects
Covid19Unlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of solicited symptoms of reactogenicity
Day 1 through Day 8 post each immunization

Subject reported symptoms of local and systemic reactogenicity

Grade of solicited symptoms of reactogenicity
Day 1 through Day 8 post each immunization

Subject reported symptoms of local and systemic reactogenicity

Frequency of unsolicited adverse events
Day 1 through Day 29 post each immunization

Any adverse events observed or reported following vaccination

Grade of unsolicited adverse events
Day 1 through Day 29 post each immunization

Any adverse events observed or reported following vaccination

Frequency of serious adverse events (SAEs)
Day 1 through Day 390

Any adverse events reported following vaccination meeting definition of serious

Frequency of medically-attended adverse events (MAAEs)
Day 1 through Day 390

Any adverse events reported following vaccination meeting definition of serious

Secondary Endpoints

SARS-CoV-2 specific IgG/IgA
Day 1 through Day 390
Neutralizing antibody titers to SARS-CoV-2
Day 1 through Day 390
Antigen-specific IgG/IgA antibody secreting (ASCs)
Day 1 through Day 44
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Low Dose VXA-CoV2-1EXPERIMENTALLow dose (1E10 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1. A subset will also receive a second dose at Day 29
High DoseEXPERIMENTALHigh Dose (1E11 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1

Interventions

NameTypeDescription
VXA-CoV2-1BIOLOGICALnon replicating Ad5 adjuvanted oral tableted vaccine
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Eligibility Criteria

Age Range18 Years to 54 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female between the ages of 18 to 54 years, inclusive. 2. Negative for SARS-CoV-2 infection at the time of screening 3. In generally good health, without significant medical illness 4. Demonstrates comprehension of the protocol procedures and is able to provide written...

Countries:United States
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