The primary objective of the study is to determine the relative efficacy of theinvestigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccinetablet VXA-CoV2-3.1 compared to a currently recommended vaccine for the prevention ofsymptomatic Coronavirus Disease 2019 (COVID-19).
Not Provided
Biological: VXA-CoV2-3.1
Tablets for oral use.
Biological: COMIRNATY®
Intramuscular (IM) injection.
Other Name: Pfizer-BioNTech mRNA Vaccine
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).
Pinnacle Research Group
Anniston, Alabama, United States
Core Clinical Trials - Central Alabama Research LLC
Birmingham, Alabama, United States
Coastal Clinical Research
Mobile, Alabama, United States
Avacare - Lenzmeier Family Medicine
Glendale, Arizona, United States
Desert Clinical Research
Mesa, Arizona, United States
Velocity Clinical Research - MedPharmics - Phoenix
Phoenix, Arizona, United States
Foothills Research Center
Phoenix, Arizona, United States
Avacare (CCT) - Fiel Family & Sports Medicine
Tempe, Arizona, United States
Baptist Health Center for Clinical Research - Little Rock
Little Rock, Arkansas, United States
Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group
Cerritos, California, United States
Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)
Chula Vista, California, United States
Avacare - Benchmark Research - SOCAL-Colton
Colton, California, United States
Altasciences Los Angeles (Formerly WCCT Global)
Cypress, California, United States
Ark Clinical Research - Fountain Valley, CA
Fountain Valley, California, United States
Velocity Clinical Research - San Diego (eStudySite - La Mesa)
La Mesa, California, United States
Ark Clinical Research - Long Beach, CA
Long Beach, California, United States
Velocity Clinical Research (National Research Institute) - Panorama City
Los Angeles, California, United States
Northern California Research
Sacramento, California, United States
Avacare - Benchmark Research - Sacramento
Sacramento, California, United States
Velocity Clinical Research - Gardena
Santa Ana, California, United States
Elite Research Network (ERN) - Legacy Clinical Trials
Colorado Springs, Colorado, United States
Tekton Research - Fort Collins
Fort Collins, Colorado, United States
Avacare - Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, United States
Tekton Research - Colorado - Longmont
Longmont, Colorado, United States
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Chase Medical Research
Waterbury, Connecticut, United States
Velocity Clinical Research - Washington DC
Washington, District of Columbia, United States
AMR - Miami (Clinical Research of South Florida)
Coral Gables, Florida, United States
Universal Axon Clinical Research
Doral, Florida, United States
Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, United States
Fleming Island Center For Clinical Research
Fleming Island, Florida, United States
AMR - Fort Myers - Clinical Physiology Associates
Fort Myers, Florida, United States
Velocity Clinical Research - Hallandale Beach (MD Clinical)
Hallandale Beach, Florida, United States
ENCORE - Nature Coast Clinical Research Inverness
Inverness, Florida, United States
ENCORE - Westside Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Headlands Research - JEM Research - Lake Worth
Lake Worth, Florida, United States
Accel Research Sites - Lakeland
Lakeland, Florida, United States
Accel Research Sites (ARS) - St. Petersburg - Largo
Largo, Florida, United States
Accel Research Sites - Maitland
Maitland, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates
Miami, Florida, United States
Atlas Clinical Research - Suncoast Clinical Research - Pasco County
New Port Richey, Florida, United States
Biscayne Clinical Research
North Miami Beach, Florida, United States
K2 Medical Research - South Orlando
Orlando, Florida, United States
Boca Raton Clinical Research (BRCR) Global - Weston
Plantation, Florida, United States
ENCORE - St. Johns Center for Clinical Research
Saint Augustine, Florida, United States
IMA Clinical Research - St. Petersburg
Saint Petersburg, Florida, United States
hyperCORE - Centricity Research Columbus
Columbus, Georgia, United States
Javara Research - Privia Medical Group Georgia
Fayetteville, Georgia, United States
Privia Health - SouthCoast Health
Fayetteville, Georgia, United States
Avacare (CCT) - Lifeline Primary Care
Lilburn, Georgia, United States
hyperCORE - Centricity Research (IACT Health) - Rincon
Rincon, Georgia, United States
Velocity Clinical Research - Savannah
Savannah, Georgia, United States
Velocity Clinical Research - Boise (Meridian)
Meridian, Idaho, United States
IMA Clinical Research - Chicago
Chicago, Illinois, United States
Accellacare - Duly Health and Care
Lombard, Illinois, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
Valparaiso, Indiana, United States
Accellacare - McFarland Clinic
Ames, Iowa, United States
Velocity (Meridian) Clinical Research - Sioux City
Sioux City, Iowa, United States
AMR - El Dorado - Heartland Research Associates
El Dorado, Kansas, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
AMR - Newton (Heartland Research Associates)
Newton, Kansas, United States
AMR - Wichita West - Heartland Research Associates
Wichita, Kansas, United States
AMR - Wichita East - Heartland Research Associates
Wichita, Kansas, United States
AMR - Lexington (Central Kentucky Research Associates)
Lexington, Kentucky, United States
Velocity (Meridian) Clinical Research - Baton Rouge
Baton Rouge, Louisiana, United States
Avacare - Benchmark Research - New Orleans-North Shore
Covington, Louisiana, United States
Velocity Clinical Research - MedPharmics - Covington
Covington, Louisiana, United States
Boca Raton Clinical Research (BRCR) Global USA - New Orleans
Gretna, Louisiana, United States
Velocity Clinical Research - MedPharmics - Lafayette
Lafayette, Louisiana, United States
Avacare - Benchmark Research - Metairie
Metairie, Louisiana, United States
AMR - New Orleans - Center for Clinical Research
New Orleans, Louisiana, United States
Javara Research - Privia Medical Group Mid-Atlantic - Annapolis
Annapolis, Maryland, United States
Pharmaron
Baltimore, Maryland, United States
Avacare (CCT) - Advanced Primary and Geriatric Care
Rockville, Maryland, United States
Velocity (Meridian) Clinical Research - Rockville
Rockville, Maryland, United States
Javara Research - Mankato Clinic
Mankato, Minnesota, United States
Velocity Clinical Research - MedPharmics - Gulfport
Gulfport, Mississippi, United States
Avacare (CCT) - Clay Platte Family Medicine Clinic
Kansas City, Missouri, United States
Avacare (CCT) - Skyline Medical Center
Elkhorn, Nebraska, United States
Velocity (Meridian) Clinical Research - Grand Island
Grand Island, Nebraska, United States
Be Well Clinical Studies - Nebraska
Lincoln, Nebraska, United States
Velocity (Meridian) Clinical Research - Omaha
Omaha, Nebraska, United States
hyperCORE - ActivMed Practices and Research - Portsmouth
Portsmouth, New Hampshire, United States
DM Clinical Research - Jersey City
Jersey City, New Jersey, United States
Velocity Clinical Research - Alburquerque
Albuquerque, New Mexico, United States
AXCES Research & Health - Santa Fe
Santa Fe, New Mexico, United States
IMA Clinical Research - Albany, Suite 202
Albany, New York, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, United States
IMA Clinical Research - Manhattan
New York, New York, United States
Atlas Clinical Research - Rochester Clinical Research
Rochester, New York, United States
Cary Medical Group
Cary, North Carolina, United States
Velocity Clinical Research - Durham
Durham, North Carolina, United States
Accellacare - Hickory
Hickory, North Carolina, United States
Accellacare - Raleigh
Raleigh, North Carolina, United States
Accellacare - Rocky Mount
Rocky Mount, North Carolina, United States
Accellacare - Salisbury
Salisbury, North Carolina, United States
Accellacare - Piedmont Healthcare
Statesville, North Carolina, United States
Accellacare - Tradd Court
Wilmington, North Carolina, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, United States
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Velocity Clinical Research - Cleveland (Rapid Medical Research)
Beachwood, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)
Cincinnati, Ohio, United States
Tekton Research - Oklahoma - Magnolia Court
Moore, Oklahoma, United States
Tekton Research - Delaware Pointe
Tulsa, Oklahoma, United States
Tekton Research - Oklahoma - Primary Health Partners
Yukon, Oklahoma, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, United States
Avacare (CCT) - Hatboro Medical Associates
Hatboro, Pennsylvania, United States
Atlas Clinical Research - Suburban Research Associates - Media Office
Media, Pennsylvania, United States
Velocity Clinical Research - Providence (East Greenwich)
East Greenwich, Rhode Island, United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, United States
Velocity Clinical Research - Charleston
Charleston, South Carolina, United States
Velocity Clinical Research - Columbia (VitaLink)
Columbia, South Carolina, United States
Accellacare - Charleston
Mount Pleasant, South Carolina, United States
Trial Management Associates - Myrtle Beach
Myrtle Beach, South Carolina, United States
hyperCORE International - Coastal Carolina Research Center
North Charleston, South Carolina, United States
Velocity Clinical Research - Union (Vitalink)
Union, South Carolina, United States
Accellacare - PMG Research of Bristol
Bristol, Tennessee, United States
Alliance for Multispecialty Research (AMR) - Corporate
Knoxville, Tennessee, United States
Accellacare of Knoxville
Knoxville, Tennessee, United States
Velocity Clinical Research - Abilene
Abilene, Texas, United States
IMA Clinical Research - Austin
Austin, Texas, United States
Tekton Research - Austin
Austin, Texas, United States
Orion Clinical Research
Austin, Texas, United States
Velocity Clinical Research - Austin
Austin, Texas, United States
Tekton Research - Beaumont
Beaumont, Texas, United States
PanAmerican Clinical Research - Brownsville, Levee Street
Brownsville, Texas, United States
Cedar Health Research - Arlington/Euless
Euless, Texas, United States
EmVenio Research - Fort Worth, TX
Fort Worth, Texas, United States
Avacare - Benchmark Research Fort Worth
Fort Worth, Texas, United States
DM Clinical Research - CyFair Clinical Research Center
Houston, Texas, United States
Tekton Research - Fredericksburg Road
San Antonio, Texas, United States
DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas, United States
Velocity Clinical Research - Waco (formerly: Impact Research Institute)
Waco, Texas, United States
Avacare (CCT) - Ogden Clinic - Grand View
Roy, Utah, United States
Avacare (CCT) - Olympus Family Medicine
Salt Lake City, Utah, United States
South Ogden Family Medicine
South Ogden, Utah, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
AMR - Norfolk (Clinical Research Associates of Tidewater)
Norfolk, Virginia, United States
Centricity Research (IACT Health) - Suffolk Primary Care
Suffolk, Virginia, United States
Velocity Clinical Research - Medford
Spokane, Washington, United States
Velocity Clinical Research - Spokane
Spokane, Washington, United States
James Cummings, MD, Study Director
Vaxart, Inc.