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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ monitoring for one year post last dose administration

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

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