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Study Summary
This trial will test the safety and effectiveness of a new vaccine for COVID-19.
- COVID-19
- Coronavirus
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 6104 Patients • NCT01346592Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Part 1 Cohort 1c (Naïve, low dose, older adult)
- Group 2: Part 1 Cohort 2a (Prior vaccinated, low dose, young 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 2b (Prior vaccinated, high 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)
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How old are they?
What site did they apply to?
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