← Back to Search

Virus Therapy

VXA-CoV2-1.1-S for COVID-19

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

Study Summary

This trial will test the safety and effectiveness of a new vaccine for COVID-19.

Eligible Conditions
  • COVID-19
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

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
1 Trials studying COVID-19
35 Patients Enrolled for COVID-19

Media Library

VXA-CoV2-1.1-S (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05067933 — Phase 2
COVID-19 Research Study Groups: Part 1 Cohort 1c (Naïve, low dose, older adult), Part 1 Cohort 2a (Prior vaccinated, low dose, young adult), Part 1 Cohort 1d (Naïve, high dose, older adult), Part 1 Cohort 2c (Prior vaccinated, low dose, older adult), Part 1 Cohort 2b (Prior vaccinated, high 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)
COVID-19 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any other health care facilities conducting this investigation within the state?

"Currently, AMR Wichita East in Wichita, Velocity Clinical Research Inc. in Cleveland and AMR Knoxville in Knoxville are amongst the four sites actively recruiting for this study. Additionally, there is availability at other locations as well."

Answered by AI

Is this the inaugural endeavor for such a trial?

"VXA-CoV2-1.1-S was first studied in 2021, with the opening study funded by Vaxart and involving 896 participants. After completing its Phase 2 drug approval stage that year, today there is only one active trial for this medication which is being sponsored again by Vaxart."

Answered by AI

Have prior research initiatives investigated VXA-CoV2-1.1-S?

"VXA-CoV2-1.1-S was first researched at Ark Clinical Research in 2021, with 16 trials having been completed. The current studies are centred around Wichita, Kansas and there is one still active trial."

Answered by AI

May I become a participant in this clinical investigation?

"To be admitted to this clinical study, the participant must have been infected with covid-19 and they must fall between 18 - 75 years. This trial is set to include 896 people in total."

Answered by AI

Does this clinical experiment allow for participation from individuals of 18 years and older?

"This research study is open to individuals over the age of majority and below 75 years old."

Answered by AI

What is the primary objective of this experiment?

"This research trial, which is estimated to take up to 36 days, aims to evaluate the incidence of unsolicited adverse events. Additionally, four weeks post second immunization (Day 57), Mesoscale Discovery assays will be used to assess changes in SARS-CoV2 specific Immunoglobulin G and A antibodies from baseline levels at Day 29."

Answered by AI

What is the participant turnout for this research experiment?

"To ensure the successful completion of this clinical trial, 896 participants must be recruited who meet all specified inclusion criteria. Vaxart will run the study from two sites: AMR Wichita East in Kansas and Velocity Clinical Research Inc. located in Ohio."

Answered by AI

Are there vacancies in this clinical research for volunteers?

"The information displayed on clinicaltrials.gov verifies that this medical trial is actively looking for participants, and was originally published on October 1st 2021 before being revised as recently as September 19th 2022."

Answered by AI

What risks does VXA-CoV2-1.1-S pose to those who administer it?

"Given the Phase 2 trial status of VXA-CoV2-1.1-S, Power assigned it a safety ranking of 2 due to some data indicating its security but none demonstrating effectiveness."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Tennessee
California
What portion of applicants met pre-screening criteria?
Met criteria
How old are they?
18 - 65
What site did they apply to?
AMR Knoxville
~19 spots leftby Apr 2025