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Vxa-G1.1-Nn, Vxa-G2.4-Ns, Vxa G1.1 Nn-T, Vxa G2.4 Ns-T
Norovirus Infections
Phase I
Active Not Recruiting
A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old
Apr 17, 2025
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Vxa-Cov2-3.1, Comirnaty®, Vxa-Cov2-3.3
Covid-19, Sars-Cov2
Phase II
Recruiting
A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection
Nov 01, 2024
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Open Label Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 Medium Dose Vaccine 1×10 To The Power 11 Iu/Dose
Norovirus Infections
Phase II
Completed
A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
Nov 15, 2022
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Vxa-G1.1-Nn, Norovirus Gi.1 Norwalk Virus Inoculum
Norovirus Infections
Phase I/II
Completed
Norovirus Challenge Study
Jan 25, 2022
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Vxa-G1.1-Nn
Norovirus Infections
Phase I
Completed
A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers
Jan 18, 2022
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Vxa-Cov2-1.1-S
Covid-19
Phase II
Terminated
A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
Sep 16, 2021
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Vxa-Gi.1.Nn
Norovirus Infections
Phase I
Completed
Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine
Apr 19, 2021
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Vxa-G1.1-Nn
Norovirus Infections
Phase I/II
Completed
Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines
Apr 19, 2021
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Vxa-Cov2-1
COVID19
Phase I
Completed
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
Sep 21, 2020
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Vxa-G1.1-Nn, Vxa-G2.4-Ns
Norovirus Infection
Phase I
Completed
Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines
Mar 28, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Vaxart Inc (VXRT) have in its pipeline
VXRT is currently developing the following drugs: Vxa-G1.1-Nn, Vxa-G2.4-Ns, Vxa G1.1 Nn-T, Vxa G2.4 Ns-T, Vxa-Cov2-3.1, Comirnaty®, Vxa-Cov2-3.3, Open Label Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 High Dose Vaccine 2×10 To The Power 11 Iu/Dose, Bivalent Gii.4/Gi.1 Medium Dose Vaccine 1×10 To The Power 11 Iu/Dose. These drug candidates are in various stages of clinical development as the company works toward FDA approval.