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Virus Therapy
Oral Vaccine for COVID-19
Phase 2
Recruiting
Research Sponsored by Vaxart
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Completed primary approved/authorized COVID-19 vaccination series with ≥ 2 mRNA vaccine doses
Be older than 18 years old
Must not have
Use of drugs known to affect gastrointestinal motility including glucagon-like peptide 1 (GLP-1) receptor agonists within 30 days prior to drug administration
Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to compare how well a new oral COVID-19 vaccine (VXA-CoV2-3.1) works in preventing symptomatic COVID-19 compared to the currently recommended vaccine."
Who is the study for?
This trial is for adults who have already been vaccinated against COVID-19. Participants should be in good health and not currently infected with COVID-19. The full eligibility criteria are not provided, so additional requirements may apply.
What is being tested?
The study is testing the effectiveness of a new oral vaccine tablet called VXA-CoV2-3.1 compared to an existing mRNA booster shot, COMIRNATY®, for preventing symptoms of COVID-19 in previously immunized adults.
What are the potential side effects?
Specific side effects are not listed, but generally, vaccines can cause reactions at the injection or pill intake site, fever, fatigue, headache, muscle pain, chills, joint pain and possibly other mild to moderate symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed the COVID-19 vaccination series with 2 or more mRNA doses.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken drugs affecting stomach movement, like GLP-1 agonists, in the last 30 days.
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I have not taken NSAIDs in the last 7 days and do not plan to during the study.
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I have a history of inflammatory bowel disease or similar conditions.
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I have had unexplained or unevaluated GI bleeding, including blood or black stool.
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I haven't received or donated blood products within the last 60 days.
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I do not have any autoimmune or severe immune deficiency conditions.
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I haven't received any COVID-19 prevention products in the last 6 months.
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I cannot have injections, blood draws, or swallow pills due to medical reasons.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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I have a history of blood clots or my family has a history of clotting disorders.
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I have had myocarditis or pericarditis in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Percentage of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Side effects data
From 2023 Phase 4 trial • 267 Patients • NCT050070418%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VXA-CoV2-3.1Experimental Treatment1 Intervention
Participants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 tablet oral vaccine.
Group II: COMIRNATY®Active Control1 Intervention
Participants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® injectable COVID-19 vaccine.
Find a Location
Who is running the clinical trial?
VaxartLead Sponsor
21 Previous Clinical Trials
1,428 Total Patients Enrolled
James Cummings, MDStudy DirectorVaxart, Inc.
7 Previous Clinical Trials
931 Total Patients Enrolled