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Virus Therapy
A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
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
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 moreTrial 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
21 Previous Clinical Trials
11,362 Total Patients Enrolled
James Cummings, MDStudy DirectorVaxart, Inc.
7 Previous Clinical Trials
10,865 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had bleeding in your digestive system before or during the active period of the study.You have taken or plan to take medications to treat viruses, such as HIV, within a week before the study or during the study period.You cannot take certain medications like aspirin or ibuprofen for a week before or during the study.You have a history or condition that increases the risk of blood clots, such as a family history of bleeding or clotting, previous blood clotting events, autoimmune or inflammatory disease, recent surgery or immobility for over 3 days, head trauma with loss of consciousness, use of blood thinners, or recent significant infection.You cannot have taken antibiotics, acid reducers or heartburn medication a week before or during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Cohort 2b (Prior vaccinated, high dose, young adult)
- Group 2: Part 1 Cohort 1c (Naïve, low dose, older adult)
- Group 3: Part 1 Cohort 1d (Naïve, high dose, older adult)
- Group 4: Part 1 Cohort 2c (Prior vaccinated, low dose, older adult)
- Group 5: Part 1 Cohort 2a (Prior vaccinated, low dose, young adult)
- Group 6: Part 2 Healthy Adults: Active vaccine
- Group 7: Part 2 Healthy Adults: Placebo control
- Group 8: Part 1 Cohort 2d (Prior vaccinated, high dose, older adult)
- Group 9: Part 1 Cohort 1a (Naïve, low dose, young adult)
- Group 10: Part 1 Cohort 1b (Naïve, high dose, young adult)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.