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Virus Therapy

VXA-CoV2-1.1-S for Coronavirus

Phase 2
Waitlist Available
Research Sponsored by Vaxart
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitoring for one year post last dose administration
Awards & highlights

Summary

This trial tests an oral pill vaccine called VXA-CoV2-1.1-S in healthy adults aged 18-75, including those who have and haven't received mRNA vaccines. The pill helps the body learn to fight COVID-19 by using a harmless virus to show it a small part of the real virus.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitoring for one year post last dose administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and monitoring for one year post last dose administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Solicited Symptoms of Reactogenicity Collected via a Diary Card (Part 1 and Part 2)
Rate of Unsolicited Adverse Events (Part 1 and Part 2)
Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs)
Secondary study objectives
To assess the induction of ASC IgA in (PBMCs)
To assess the induction of ASC IgG in (PBMCs)
To assess the induction of SARS-CoV2-specific IgA antibody levels by MSD assay
+4 more

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041
8%
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

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 Healthy Adults: Active vaccineExperimental Treatment1 Intervention
Repeat dose vaccinations with VXA-CoV2-1.1-S at dose selected from Part 1 in healthy male and female adult volunteers 18 to 75 years old
Group II: Part 1 Cohort 2d (Prior vaccinated, high dose, older adult)Experimental Treatment1 Intervention
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who have received prior vaccinations with an mRNA vaccine
Group III: Part 1 Cohort 2c (Prior vaccinated, low dose, older adult)Experimental Treatment1 Intervention
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who have received prior vaccinations with an mRNA vaccine
Group IV: Part 1 Cohort 2b (Prior vaccinated, high dose, young adult)Experimental Treatment1 Intervention
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who have received prior vaccinations with an mRNA vaccine
Group V: Part 1 Cohort 2a (Prior vaccinated, low dose, young adult)Experimental Treatment1 Intervention
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who have received prior vaccinations with an mRNA vaccine
Group VI: Part 1 Cohort 1d (Naïve, high dose, older adult)Experimental Treatment1 Intervention
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who are vaccine naïve
Group VII: Part 1 Cohort 1c (Naïve, low dose, older adult)Experimental Treatment1 Intervention
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who are vaccine naïve
Group VIII: Part 1 Cohort 1b (Naïve, high dose, young adult)Experimental Treatment1 Intervention
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who are vaccine naïve
Group IX: Part 1 Cohort 1a (Naïve, low dose, young adult)Experimental Treatment1 Intervention
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who are vaccine naïve
Group X: Part 2 Healthy Adults: Placebo controlPlacebo Group1 Intervention
Repeat dose administration with matching placebo tablets in healthy male and female adult volunteers 18 to 75 years old
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VXA-CoV2-1.1-S
2021
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

VaxartLead Sponsor
20 Previous Clinical Trials
1,362 Total Patients Enrolled
James Cummings, MDStudy DirectorVaxart, Inc.
6 Previous Clinical Trials
865 Total Patients Enrolled

Media Library

VXA-CoV2-1.1-S (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05067933 — Phase 2
Coronavirus Research Study Groups: Part 1 Cohort 2b (Prior vaccinated, high dose, young adult), Part 1 Cohort 1c (Naïve, low dose, older adult), Part 1 Cohort 1d (Naïve, high dose, older adult), Part 1 Cohort 2c (Prior vaccinated, low dose, older adult), Part 1 Cohort 2a (Prior vaccinated, low dose, young adult), Part 2 Healthy Adults: Active vaccine, Part 2 Healthy Adults: Placebo control, Part 1 Cohort 2d (Prior vaccinated, high dose, older adult), Part 1 Cohort 1a (Naïve, low dose, young adult), Part 1 Cohort 1b (Naïve, high dose, young adult)
Coronavirus Clinical Trial 2023: VXA-CoV2-1.1-S Highlights & Side Effects. Trial Name: NCT05067933 — Phase 2
VXA-CoV2-1.1-S (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05067933 — Phase 2
~17 spots leftby Sep 2025
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