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Purpose

The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.1 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Adults 18 years of age and above, at time of screening. 2. Completed primary approved/authorized COVID-19 vaccination series with ≥ 2 mRNA vaccine doses. 3. Last COVID-19 vaccine received ≥6 months prior to study vaccination. 4. Male and female participants of childbearing potential must agree to consistently use a highly effective method of contraception from at least 30 days prior to enrollment and through 3 months after the last study vaccination. 5. Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination) with screening lab values within normal limits or abnormalities assessed as not clinically significant. 6. Agree to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, PrEP) during participation in the study. 7. Willing and able to provide informed consent prior to initiation of study procedures. 8. Available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study. 9. Negative rapid molecular Covid test at the screening visit and on Day 1 prior to vaccine dosing.

Exclusion Criteria

  1. Participant has an acute illness as defined by any of the following (note: assessment may be repeated once during screening period): a. As determined by the site investigator, within 72 hours prior to vaccination. i. An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol. b. Presence of a fever ≥ 38.0°C (100.4°F) measured orally at baseline, on Day 1 prior to vaccination. c. Receipt of antipyretic/analgesic medications within 24 hours prior to vaccine administration. 2. Participant has had a positive COVID test within 90 days prior to screening. 3. Current or planned participation in any other interventional clinical trial. 4. Participation in research involving any investigational product within 45 days prior to study vaccination. 5. Receipt of any approved or authorized products intended to prevent SARS-CoV2 infection within 6 months prior to study vaccination. 6. Receipt or donation of blood products or immunoglobulins within 60 days prior to enrollment or planned administration during the study. 7. Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination. 8. Any autoimmune or immunodeficiency disease/condition (including and not limited to untreated or advanced HIV infection with CD4 counts <200 cells/mm^3, history of AIDS defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV, severe combined immunodeficiency (SCID), hypogammaglobulinemia, asplenia or functional asplenia). 9. Unstable medical or psychiatric illness (acute or chronic illness) requiring significant medical monitoring and intervention during the 90 days prior to enrollment. Note: diabetes mellitus (Types 1 & 2) are not excluded if assessed by the principal investigator (PI) as well-controlled. 10. Administration of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within the following timeframes: 1. B-cell therapies within the 6 months prior to first study vaccination 2. Prednisone, ≥20 mg for more than 2 weeks, within the 30 days prior to study vaccination 3. Other medications in this category, including but not limited to high-dose inhaled corticosteroids (>800 mcg/day of beclomethasone dipropionate or equivalent); antimetabolites; transplant immunosuppressive agents; alkylating agents; cell-depleting agents; or cancer chemotherapeutics, within the 90 days prior to study vaccination. 4. Any medication for any period of time that, in the opinion of the site investigator, could impede immune response to vaccination. 5. Use of any dose montelukast OR inhaled, intranasal, intra-articular, or systemic corticosteroids within 2 weeks prior to study vaccination. 6. Planned use of any of these medications during the study. 11. Known contraindication to IM injection or blood draws (e.g. bleeding diathesis, acquired coagulopathy, significant bleeding or bruising) or to oral route of administration (unable to swallow tablets). 12. Any known allergies to components contained in the investigational product (including fish gelatin) or comparator or latex allergy (including polyethylene glycol [PEG] allergies) and/or history of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain. 13. Women who are pregnant (pregnancy tests will be performed at screening and prior to dosing), breastfeeding, or who plan to become pregnant during the study. 14. History of irritable bowel disease or other inflammatory digestive or gastrointestinal condition that could affect the distribution/safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine. Such conditions may include but are not limited to: a. Any history of: i. GI malignancy ii. malabsorption iii. pancreatobiliary disorders iv. inflammatory bowel disease v. irritable bowel disease vi. hiatal hernia vii. surgical resection b. History of diagnosis or treatment in past 5 years of: i. esophageal or gastric motility disorder ii. gastroesophageal reflux disorder iii. peptic ulcer iv. cholecystectomy. 15. Use of antibiotics, proton pump inhibitors, H2 blockers, or antacids within 7 days prior to study drug administration or planned use during the study. 16. Use of drugs known to affect gastrointestinal motility including glucagon-like peptide 1 (GLP-1) receptor agonists including tirzepatide (Mounjaro) and semaglutide (Wegovy, Ozempic) within 30 days prior to drug administration. 17. Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the study. 18. Personal or familial history of hypercoagulable states to include personal past history of deep vein thrombosis (DVT). 19. Personal history of myocarditis or pericarditis. 20. Positive Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at the screening visit. 21. History of drug, alcohol, or chemical abuse within 1 year of screening. 22. Positive urine drug screen for drugs of abuse at screening (except for previous marijuana use); concurrent or planned use of marijuana during the active study period are excluded. Positive urine drug screen (UDS) at screening due to prescribed stimulants will be reviewed on a case by case basis. 23. Cancer, or treatment for cancer, within the past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma). 24. History of any form of angioedema. 25. History of GI bleeding including hematochezia (blood in stool) or melena (black stool) of unknown etiology or that has not been evaluated. 26. Any history or conditions that may lead to a higher risk of clotting events and/or thrombocytopenia, including: 1. Familial coagulopathy or personal history of bleeding disorder or thrombosis 2. History of heparin-related thrombotic events, and/or receiving heparin treatments 3. History of autoimmune or inflammatory disease 4. Presence of any of the following conditions known to increase the risk of thrombosis within 6 months prior to screening: i. Recent surgery other than fully healed cesarean delivery or excision/ biopsy of cutaneous lesions ii. Immobility (confined to bed or wheelchair for 3 or more successive days) iii. Head trauma with loss of consciousness or documented brain injury iv. Receipt of anticoagulants for prophylaxis of thrombosis v. Recent clinically significant infection including hospitalization for COVID-19 related illness. 27. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the investigational product or interpretation of study results. 28. Study team member or first-degree relative of any study team member (inclusive of sponsor and site personnel involved in the study).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VXA-CoV2-3.1 		Participants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 tablet oral vaccine.
  • Biological: VXA-CoV2-3.1
    Tablets for oral use.
Active Comparator
COMIRNATY® 		Participants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® injectable COVID-19 vaccine.
  • Biological: COMIRNATY®
    Intramuscular (IM) injection.
    Other names:
    • Pfizer-BioNTech mRNA Vaccine

Recruiting Locations

Pinnacle Research Group
Anniston, Alabama 36207

Core Clinical Trials - Central Alabama Research LLC
Birmingham, Alabama 35209-8401

Coastal Clinical Research
Mobile, Alabama 36608

Avacare - Lenzmeier Family Medicine
Glendale, Arizona 85308

Desert Clinical Research
Mesa, Arizona 85213

Velocity Clinical Research - MedPharmics - Phoenix
Phoenix, Arizona 85020

Foothills Research Center
Phoenix, Arizona 85044

Avacare (CCT) - Fiel Family & Sports Medicine
Tempe, Arizona 85283

Baptist Health Center for Clinical Research - Little Rock
Little Rock, Arkansas 72205

Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group
Cerritos, California 90703

Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)
Chula Vista, California 91911

Avacare - Benchmark Research - SOCAL-Colton
Colton, California 92324

Altasciences Los Angeles (Formerly WCCT Global)
Cypress, California 90630

Ark Clinical Research - Fountain Valley, CA
Fountain Valley, California 92708

Velocity Clinical Research - San Diego (eStudySite - La Mesa)
La Mesa, California 91942

Ark Clinical Research - Long Beach, CA
Long Beach, California 90815

Velocity Clinical Research (National Research Institute) - Panorama City
Los Angeles, California 90057

Northern California Research
Sacramento, California 95821

Avacare - Benchmark Research - Sacramento
Sacramento, California 95864

Velocity Clinical Research - Gardena
Santa Ana, California 92704

Elite Research Network (ERN) - Legacy Clinical Trials
Colorado Springs, Colorado 80909

Tekton Research - Fort Collins
Fort Collins, Colorado 80528

Avacare - Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado 80228

Tekton Research - Colorado - Longmont
Longmont, Colorado 80501

Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado 80033

Stamford Therapeutics Consortium
Stamford, Connecticut 06905

Chase Medical Research
Waterbury, Connecticut 06708

Velocity Clinical Research - Washington DC
Washington, District of Columbia 20016

AMR - Miami (Clinical Research of South Florida)
Coral Gables, Florida 33134

Universal Axon Clinical Research
Doral, Florida 33166

Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida 32132

Fleming Island Center For Clinical Research
Fleming Island, Florida 32003

AMR - Fort Myers - Clinical Physiology Associates
Fort Myers, Florida 33912

Velocity Clinical Research - Hallandale Beach (MD Clinical)
Hallandale Beach, Florida 33009

ENCORE - Nature Coast Clinical Research Inverness
Inverness, Florida 34452

ENCORE - Westside Center for Clinical Research
Jacksonville, Florida 32205

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216

Headlands Research - JEM Research - Lake Worth
Lake Worth, Florida 33462

Accel Research Sites - Lakeland
Lakeland, Florida 33803

Accel Research Sites (ARS) - St. Petersburg - Largo
Largo, Florida 33777

Accel Research Sites - Maitland
Maitland, Florida 32751

K2 Medical Research - Maitland
Maitland, Florida 32751

SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates
Miami, Florida 33173

Atlas Clinical Research - Suncoast Clinical Research - Pasco County
New Port Richey, Florida 34652

Biscayne Clinical Research
North Miami Beach, Florida 33169

K2 Medical Research - South Orlando
Orlando, Florida 32806

Boca Raton Clinical Research (BRCR) Global - Weston
Plantation, Florida 33322

ENCORE - St. Johns Center for Clinical Research
Saint Augustine, Florida 32086

IMA Clinical Research - St. Petersburg
Saint Petersburg, Florida 33704

hyperCORE - Centricity Research Columbus
Columbus, Georgia 31904

Javara Research - Privia Medical Group Georgia
Fayetteville, Georgia 30214

Privia Health - SouthCoast Health
Fayetteville, Georgia 30214

Avacare (CCT) - Lifeline Primary Care
Lilburn, Georgia 30047

hyperCORE - Centricity Research (IACT Health) - Rincon
Rincon, Georgia 31326

Velocity Clinical Research - Savannah
Savannah, Georgia 31406

Velocity Clinical Research - Boise (Meridian)
Meridian, Idaho 83642

IMA Clinical Research - Chicago
Chicago, Illinois 60602

Accellacare - Duly Health and Care
Lombard, Illinois 60148

Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
Valparaiso, Indiana 46383

Accellacare - McFarland Clinic
Ames, Iowa 50010

Velocity (Meridian) Clinical Research - Sioux City
Sioux City, Iowa 51106

AMR - El Dorado - Heartland Research Associates
El Dorado, Kansas 67042

Johnson County Clin-Trials
Lenexa, Kansas 66219

AMR - Newton (Heartland Research Associates)
Newton, Kansas 67114

AMR - Wichita West - Heartland Research Associates
Wichita, Kansas 67205

AMR - Wichita East - Heartland Research Associates
Wichita, Kansas 67207

AMR - Lexington (Central Kentucky Research Associates)
Lexington, Kentucky 40509

Velocity (Meridian) Clinical Research - Baton Rouge
Baton Rouge, Louisiana 70809

Avacare - Benchmark Research - New Orleans-North Shore
Covington, Louisiana 70433

Velocity Clinical Research - MedPharmics - Covington
Covington, Louisiana 70433

Boca Raton Clinical Research (BRCR) Global USA - New Orleans
Gretna, Louisiana 70053

Velocity Clinical Research - MedPharmics - Lafayette
Lafayette, Louisiana 70508

Avacare - Benchmark Research - Metairie
Metairie, Louisiana 70006

AMR - New Orleans - Center for Clinical Research
New Orleans, Louisiana 70119

Javara Research - Privia Medical Group Mid-Atlantic - Annapolis
Annapolis, Maryland 21401

Pharmaron
Baltimore, Maryland 21201

Avacare (CCT) - Advanced Primary and Geriatric Care
Rockville, Maryland 20850

Velocity (Meridian) Clinical Research - Rockville
Rockville, Maryland 20854

Javara Research - Mankato Clinic
Mankato, Minnesota 56001

Velocity Clinical Research - MedPharmics - Gulfport
Gulfport, Mississippi 39503

Avacare (CCT) - Clay Platte Family Medicine Clinic
Kansas City, Missouri 64151

Avacare (CCT) - Skyline Medical Center
Elkhorn, Nebraska 68022

Velocity (Meridian) Clinical Research - Grand Island
Grand Island, Nebraska 68803

Be Well Clinical Studies - Nebraska
Lincoln, Nebraska 68516

Velocity (Meridian) Clinical Research - Omaha
Omaha, Nebraska 68134

hyperCORE - ActivMed Practices and Research - Portsmouth
Portsmouth, New Hampshire 03801

DM Clinical Research - Jersey City
Jersey City, New Jersey 07306

Velocity Clinical Research - Alburquerque
Albuquerque, New Mexico 87107

AXCES Research & Health - Santa Fe
Santa Fe, New Mexico 87505

IMA Clinical Research - Albany, Suite 202
Albany, New York 12205

Velocity Clinical Research - Syracuse
East Syracuse, New York 13057

IMA Clinical Research - Manhattan
New York, New York 10036

Atlas Clinical Research - Rochester Clinical Research
Rochester, New York 14609

Cary Medical Group
Cary, North Carolina 27518

Velocity Clinical Research - Durham
Durham, North Carolina 27701

Accellacare - Hickory
Hickory, North Carolina 28601

Accellacare - Raleigh
Raleigh, North Carolina 27609

Accellacare - Rocky Mount
Rocky Mount, North Carolina 27804

Accellacare - Salisbury
Salisbury, North Carolina 28144

Accellacare - Piedmont Healthcare
Statesville, North Carolina 28625

Accellacare - Tradd Court
Wilmington, North Carolina 28401

Accellacare - Winston-Salem
Winston-Salem, North Carolina 27103

Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Winston-Salem, North Carolina 27157

Velocity Clinical Research - Cleveland (Rapid Medical Research)
Beachwood, Ohio 44122

CTI Clinical Research Center
Cincinnati, Ohio 45212

Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)
Cincinnati, Ohio 45242

Tekton Research - Oklahoma - Magnolia Court
Moore, Oklahoma 73160

Tekton Research - Delaware Pointe
Tulsa, Oklahoma 74137

Tekton Research - Oklahoma - Primary Health Partners
Yukon, Oklahoma 73099

Velocity Clinical Research - Grants Pass
Grants Pass, Oregon 97527

Avacare (CCT) - Hatboro Medical Associates
Hatboro, Pennsylvania 19040

Atlas Clinical Research - Suburban Research Associates - Media Office
Media, Pennsylvania 19063

Velocity Clinical Research - Providence (East Greenwich)
East Greenwich, Rhode Island 02818

Velocity Clinical Research - Anderson
Anderson, South Carolina 29621

Velocity Clinical Research - Charleston
Charleston, South Carolina 29414

Velocity Clinical Research - Columbia (VitaLink)
Columbia, South Carolina 29204

Accellacare - Charleston
Mount Pleasant, South Carolina 29464

Trial Management Associates - Myrtle Beach
Myrtle Beach, South Carolina 29572

hyperCORE International - Coastal Carolina Research Center
North Charleston, South Carolina 29405

Velocity Clinical Research - Union (Vitalink)
Union, South Carolina 29379

Accellacare - PMG Research of Bristol
Bristol, Tennessee 37620

Alliance for Multispecialty Research (AMR) - Corporate
Knoxville, Tennessee 37909

Accellacare of Knoxville
Knoxville, Tennessee 37912

Velocity Clinical Research - Abilene
Abilene, Texas 79606

IMA Clinical Research - Austin
Austin, Texas 78745

Tekton Research - Austin
Austin, Texas 78745

Orion Clinical Research
Austin, Texas 78759

Velocity Clinical Research - Austin
Austin, Texas 78759

Tekton Research - Beaumont
Beaumont, Texas 77706

PanAmerican Clinical Research - Brownsville, Levee Street
Brownsville, Texas 78520

Cedar Health Research - Arlington/Euless
Euless, Texas 76040

EmVenio Research - Fort Worth, TX
Fort Worth, Texas 76134

Avacare - Benchmark Research Fort Worth
Fort Worth, Texas 76135

DM Clinical Research - CyFair Clinical Research Center
Houston, Texas 77065

Tekton Research - Fredericksburg Road
San Antonio, Texas 78229

DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas 77375

Velocity Clinical Research - Waco (formerly: Impact Research Institute)
Waco, Texas 76710

Avacare (CCT) - Ogden Clinic - Grand View
Roy, Utah 84067

Avacare (CCT) - Olympus Family Medicine
Salt Lake City, Utah 84117

South Ogden Family Medicine
South Ogden, Utah 84405

Health Research of Hampton Roads
Newport News, Virginia 23606

AMR - Norfolk (Clinical Research Associates of Tidewater)
Norfolk, Virginia 23502

Centricity Research (IACT Health) - Suffolk Primary Care
Suffolk, Virginia 23435

Velocity Clinical Research - Medford
Spokane, Washington 99204

Velocity Clinical Research - Spokane
Spokane, Washington 99204

More Details

NCT ID
NCT06672055
Status
Recruiting
Sponsor
Vaxart

Study Contact

Melanie Drayton
650-392-3109
ClinicalTrials@Vaxart.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.