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-CoV2-3.3 compared to a currently recommended vaccine for the prevention ofsymptomatic Coronavirus Disease 2019 (COVID-19).In order to represent a more recently circulating SARS-CoV-2 variant, the main studyendpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not theVXA-CoV2-3.1 (XBB.1.5 strain) vaccine.
Not Provided
Biological: VXA-CoV2-3.1
Tablets for oral use.
Biological: COMIRNATY®
Intramuscular (IM) injection.
Other Name: Pfizer-BioNTech mRNA Vaccine
Biological: VXA-CoV2-3.3
Tablets for oral use.
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 study vaccination.
5. Male participants must refrain from sperm donation from the day of study vaccination
through the end of the study. Female participants must refrain from egg donation at
least 30 days prior to study vaccination through the end of the study.
6. 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. Screening platelet count must be >140,000/μL.
7. Agree to not participate in any other SARS-CoV-2 infection prevention trial
(vaccine, drug, biologic, PrEP) during participation in the study.
8. Willing and able to provide informed consent prior to initiation of study
procedures.
9. 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.
10. 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) as determined by the site
investigator, within 72 hours prior to vaccination as follows:
1. 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.
2. Presence of a fever ≥ 38.0°C (100.4°F) measured orally at baseline, on Day 1
prior to vaccination.
3. 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 the above medications during the study.
7. Concomitant allergen immunotherapy (AIT) will be allowed only if the
participant is stable in the maintenance phase of AIT. Maintenance AIT should
not be dosed for at least 7 days before and 7 days after study vaccine dosing,
and the PI must document the treating allergist's approval.
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 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:
1. Any history of:
- GI malignancy
- malabsorption
- pancreatobiliary disorders
- inflammatory bowel disease
- irritable bowel disease
- hiatal hernia
- surgical resection
2. History of diagnosis or treatment in past 5 years of:
- esophageal or gastric motility disorder
- gastroesophageal reflux disorder
- peptic ulcer
- cholecystectomy.
15. Use of antibiotics, proton pump inhibitors, H2 blockers, or antacids within 7 days
prior to study drug administration or planned use from dosing through Day 31.
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 occasional
marijuana use). Concurrent or planned use of marijuana from dosing through Day 31 is
prohibited. 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:
- Recent surgery other than fully healed cesarean delivery or excision/
biopsy of cutaneous lesions
- Immobility (confined to bed or wheelchair for 3 or more successive days)
- Head trauma with loss of consciousness or documented brain injury
- Receipt of anticoagulants for prophylaxis of thrombosis
- 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 4830198, Alabama 4829764, United States
Core Clinical Trials - Central Alabama Research LLC
Birmingham 4049979, Alabama 4829764, United States
Coastal Clinical Research
Mobile 4076598, Alabama 4829764, United States
Avacare - Lenzmeier Family Medicine
Glendale 5295985, Arizona 5551752, United States
Desert Clinical Research
Mesa 5304391, Arizona 5551752, United States
Velocity Clinical Research - MedPharmics - Phoenix
Phoenix 5308655, Arizona 5551752, United States
Foothills Research Center
Phoenix 5308655, Arizona 5551752, United States
Avacare (CCT) - Fiel Family & Sports Medicine
Tempe 5317058, Arizona 5551752, United States
Baptist Health Center for Clinical Research - Little Rock
Little Rock 4119403, Arkansas 4099753, United States
Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group
Cerritos 5335663, California 5332921, United States
Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)
Chula Vista 5336899, California 5332921, United States
Avacare - Benchmark Research - SOCAL-Colton
Colton 5338783, California 5332921, United States
Altasciences Los Angeles (Formerly WCCT Global)
Cypress 5341256, California 5332921, United States
Ark Clinical Research - Fountain Valley, CA
Fountain Valley 5350207, California 5332921, United States
Velocity Clinical Research - San Diego (eStudySite - La Mesa)
La Mesa 5363990, California 5332921, United States
Ark Clinical Research - Long Beach, CA
Long Beach 5367929, California 5332921, United States
Velocity Clinical Research (National Research Institute) - Panorama City
Los Angeles 5368361, California 5332921, United States
Northern California Research
Sacramento 5389489, California 5332921, United States
Avacare - Benchmark Research - Sacramento
Sacramento 5389489, California 5332921, United States
Velocity Clinical Research - Gardena
Santa Ana 5392900, California 5332921, United States
Elite Research Network (ERN) - Legacy Clinical Trials
Colorado Springs 5417598, Colorado 5417618, United States
Tekton Research - Fort Collins
Fort Collins 5577147, Colorado 5417618, United States
Avacare - Critical Care, Pulmonary and Sleep Associates
Lakewood 5427946, Colorado 5417618, United States
Tekton Research - Colorado - Longmont
Longmont 5579276, Colorado 5417618, United States
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge 5443948, Colorado 5417618, United States
Stamford Therapeutics Consortium
Stamford 4843564, Connecticut 4831725, United States
Chase Medical Research
Waterbury 4845193, Connecticut 4831725, United States
Velocity Clinical Research - Washington DC
Washington D.C. 4140963, District of Columbia 4138106, United States
AMR - Miami (Clinical Research of South Florida)
Coral Gables 4151871, Florida 4155751, United States
Universal Axon Clinical Research
Doral 4153471, Florida 4155751, United States
Velocity Clinical Research - New Smyrna Beach
Edgewater 4154205, Florida 4155751, United States
Fleming Island Center For Clinical Research
Fleming Island 4155594, Florida 4155751, United States
AMR - Fort Myers - Clinical Physiology Associates
Fort Myers 4155995, Florida 4155751, United States
Velocity Clinical Research - Hallandale Beach (MD Clinical)
Hallandale 4157898, Florida 4155751, United States
ENCORE - Nature Coast Clinical Research Inverness
Inverness 4159786, Florida 4155751, United States
ENCORE - Westside Center for Clinical Research
Jacksonville 4160021, Florida 4155751, United States
Jacksonville Center for Clinical Research
Jacksonville 4160021, Florida 4155751, United States
Headlands Research - JEM Research - Lake Worth
Lake Worth 4161422, Florida 4155751, United States
Accel Research Sites - Lakeland
Lakeland 4161438, Florida 4155751, United States
Accel Research Sites (ARS) - St. Petersburg - Largo
Largo 4161580, Florida 4155751, United States
Accel Research Sites - Maitland
Maitland 4163220, Florida 4155751, United States
K2 Medical Research - Maitland
Maitland 4163220, Florida 4155751, United States
SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates
Miami 4164138, Florida 4155751, United States
Atlas Clinical Research - Suncoast Clinical Research - Pasco County
New Port Richey 4165869, Florida 4155751, United States
Biscayne Clinical Research
North Miami Beach 4166233, Florida 4155751, United States
K2 Medical Research - South Orlando
Orlando 4167147, Florida 4155751, United States
Boca Raton Clinical Research (BRCR) Global - Weston
Plantation 4168782, Florida 4155751, United States
ENCORE - St. Johns Center for Clinical Research
Saint Augustine 4170894, Florida 4155751, United States
IMA Clinical Research - St. Petersburg
St. Petersburg 4171563, Florida 4155751, United States
hyperCORE - Centricity Research Columbus
Columbus 4188985, Georgia 4197000, United States
Javara Research - Privia Medical Group Georgia
Fayetteville 4194474, Georgia 4197000, United States
Privia Health - SouthCoast Health
Fayetteville 4194474, Georgia 4197000, United States
Avacare (CCT) - Lifeline Primary Care
Lilburn 4205724, Georgia 4197000, United States
hyperCORE - Centricity Research (IACT Health) - Rincon
Rincon 4218882, Georgia 4197000, United States
Velocity Clinical Research - Savannah
Savannah 4221552, Georgia 4197000, United States
Velocity Clinical Research - Boise (Meridian)
Meridian 5600685, Idaho 5596512, United States
IMA Clinical Research - Chicago
Chicago 4887398, Illinois 4896861, United States
Accellacare - Duly Health and Care
Lombard 4900373, Illinois 4896861, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
Valparaiso 4927537, Indiana 4921868, United States
Accellacare - McFarland Clinic
Ames 4846834, Iowa 4862182, United States
Velocity (Meridian) Clinical Research - Sioux City
Sioux City 4876523, Iowa 4862182, United States
AMR - El Dorado - Heartland Research Associates
El Dorado 4270863, Kansas 4273857, United States
Johnson County Clin-Trials
Lenexa 4274356, Kansas 4273857, United States
AMR - Newton (Heartland Research Associates)
Newton 4276248, Kansas 4273857, United States
AMR - Wichita West - Heartland Research Associates
Wichita 4281730, Kansas 4273857, United States
AMR - Wichita East - Heartland Research Associates
Wichita 4281730, Kansas 4273857, United States
AMR - Lexington (Central Kentucky Research Associates)
Lexington 4297983, Kentucky 6254925, United States
Velocity (Meridian) Clinical Research - Baton Rouge
Baton Rouge 4315588, Louisiana 4331987, United States
Avacare - Benchmark Research - New Orleans-North Shore
Covington 4321005, Louisiana 4331987, United States
Velocity Clinical Research - MedPharmics - Covington
Covington 4321005, Louisiana 4331987, United States
Boca Raton Clinical Research (BRCR) Global USA - New Orleans
Gretna 4326575, Louisiana 4331987, United States
Velocity Clinical Research - MedPharmics - Lafayette
Lafayette 4330145, Louisiana 4331987, United States
Avacare - Benchmark Research - Metairie
Metairie 4333177, Louisiana 4331987, United States
AMR - New Orleans - Center for Clinical Research
New Orleans 4335045, Louisiana 4331987, United States
Javara Research - Privia Medical Group Mid-Atlantic - Annapolis
Annapolis 4347242, Maryland 4361885, United States
Pharmaron
Baltimore 4347778, Maryland 4361885, United States
Avacare (CCT) - Advanced Primary and Geriatric Care
Rockville 4367175, Maryland 4361885, United States
Velocity (Meridian) Clinical Research - Rockville
Rockville 4367175, Maryland 4361885, United States
Javara Research - Mankato Clinic
Mankato 5036420, Minnesota 5037779, United States
Velocity Clinical Research - MedPharmics - Gulfport
Gulfport 4428667, Mississippi 4436296, United States
Avacare (CCT) - Clay Platte Family Medicine Clinic
Kansas City 4393217, Missouri 4398678, United States
Avacare (CCT) - Skyline Medical Center
Elkhorn 5067545, Nebraska 5073708, United States
Velocity (Meridian) Clinical Research - Grand Island
Grand Island 5069297, Nebraska 5073708, United States
Be Well Clinical Studies - Nebraska
Lincoln 5072006, Nebraska 5073708, United States
Velocity (Meridian) Clinical Research - Omaha
Omaha 5074472, Nebraska 5073708, United States
hyperCORE - ActivMed Practices and Research - Portsmouth
Portsmouth 5091383, New Hampshire 5090174, United States
DM Clinical Research - Jersey City
Jersey City 5099836, New Jersey 5101760, United States
Velocity Clinical Research - Alburquerque
Albuquerque 5454711, New Mexico 5481136, United States
AXCES Research & Health - Santa Fe
Santa Fe 5490263, New Mexico 5481136, United States
IMA Clinical Research - Albany, Suite 202
Albany 5106834, New York 5128638, United States
Velocity Clinical Research - Syracuse
East Syracuse 5116079, New York 5128638, United States
IMA Clinical Research - Manhattan
New York 5128581, New York 5128638, United States
Atlas Clinical Research - Rochester Clinical Research
Rochester 5134086, New York 5128638, United States
Cary Medical Group
Cary 4459467, North Carolina 4482348, United States
Velocity Clinical Research - Durham
Durham 4464368, North Carolina 4482348, United States
Accellacare - Hickory
Hickory 4470778, North Carolina 4482348, United States
Accellacare - Raleigh
Raleigh 4487042, North Carolina 4482348, United States
Accellacare - Rocky Mount
Rocky Mount 4488762, North Carolina 4482348, United States
Accellacare - Salisbury
Salisbury 4489985, North Carolina 4482348, United States
Accellacare - Piedmont Healthcare
Statesville 4493316, North Carolina 4482348, United States
Accellacare - Tradd Court
Wilmington 4499379, North Carolina 4482348, United States
Accellacare - Winston-Salem
Winston-Salem 4499612, North Carolina 4482348, United States
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Winston-Salem 4499612, North Carolina 4482348, United States
Velocity Clinical Research - Cleveland (Rapid Medical Research)
Beachwood 5146711, Ohio 5165418, United States
CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418, United States
Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)
Cincinnati 4508722, Ohio 5165418, United States
Tekton Research - Oklahoma - Magnolia Court
Moore 4542975, Oklahoma 4544379, United States
Tekton Research - Delaware Pointe
Tulsa 4553433, Oklahoma 4544379, United States
Tekton Research - Oklahoma - Primary Health Partners
Yukon 4556165, Oklahoma 4544379, United States
Velocity Clinical Research - Grants Pass
Grants Pass 5729080, Oregon 5744337, United States
Avacare (CCT) - Hatboro Medical Associates
Hatboro 5192863, Pennsylvania 6254927, United States
Atlas Clinical Research - Suburban Research Associates - Media Office
Media 4559575, Pennsylvania 6254927, United States
Velocity Clinical Research - Providence (East Greenwich)
East Greenwich 5221875, Rhode Island 5224323, United States
Velocity Clinical Research - Anderson
Anderson 4569298, South Carolina 4597040, United States
Velocity Clinical Research - Charleston
Charleston 4574324, South Carolina 4597040, United States
Velocity Clinical Research - Columbia (VitaLink)
Columbia 4575352, South Carolina 4597040, United States
Accellacare - Charleston
Mt. Pleasant 4588165, South Carolina 4597040, United States
Trial Management Associates - Myrtle Beach
Myrtle Beach 4588718, South Carolina 4597040, United States
hyperCORE International - Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040, United States
Velocity Clinical Research - Union (Vitalink)
Union 4599214, South Carolina 4597040, United States
Accellacare - PMG Research of Bristol
Bristol 4608657, Tennessee 4662168, United States
Alliance for Multispecialty Research (AMR) - Corporate
Knoxville 4634946, Tennessee 4662168, United States
Accellacare of Knoxville
Knoxville 4634946, Tennessee 4662168, United States
Velocity Clinical Research - Abilene
Abilene 4669635, Texas 4736286, United States
IMA Clinical Research - Austin
Austin 4671654, Texas 4736286, United States
Tekton Research - Austin
Austin 4671654, Texas 4736286, United States
Orion Clinical Research
Austin 4671654, Texas 4736286, United States
Velocity Clinical Research - Austin
Austin 4671654, Texas 4736286, United States
Tekton Research - Beaumont
Beaumont 4672989, Texas 4736286, United States
PanAmerican Clinical Research - Brownsville, Levee Street
Brownsville 4676740, Texas 4736286, United States
Cedar Health Research - Arlington/Euless
Euless 4689550, Texas 4736286, United States
EmVenio Research - Fort Worth, TX
Fort Worth 4691930, Texas 4736286, United States
Avacare - Benchmark Research Fort Worth
Fort Worth 4691930, Texas 4736286, United States
DM Clinical Research - CyFair Clinical Research Center
Houston 4699066, Texas 4736286, United States
Tekton Research - Fredericksburg Road
San Antonio 4726206, Texas 4736286, United States
DM Clinical Research - Tomball - Multiple Specialties
Tomball 4737094, Texas 4736286, United States
Velocity Clinical Research - Waco (formerly: Impact Research Institute)
Waco 4739526, Texas 4736286, United States
Avacare (CCT) - Ogden Clinic - Grand View
Roy 5780802, Utah 5549030, United States
Avacare (CCT) - Olympus Family Medicine
Salt Lake City 5780993, Utah 5549030, United States
South Ogden Family Medicine
South Ogden 5781783, Utah 5549030, United States
Health Research of Hampton Roads
Newport News 4776024, Virginia 6254928, United States
AMR - Norfolk (Clinical Research Associates of Tidewater)
Norfolk 4776222, Virginia 6254928, United States
Centricity Research (IACT Health) - Suffolk Primary Care
Suffolk 4788158, Virginia 6254928, United States
Velocity Clinical Research - Medford
Spokane 5811696, Washington 5815135, United States
Velocity Clinical Research - Spokane
Spokane 5811696, Washington 5815135, United States
Maria Apkarian
650-392-3109
ClinicalTrials@Vaxart.com
Nick D'Amato
650-392-3109
ClinicalTrials@Vaxart.com
James Cummings, MD, Study Director
Vaxart, Inc.