Could a pill replace the COVID-19 booster shot?

NCT ID NCT06672055

Vaccine Sponsor: Vaxart Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental oral COVID-19 vaccine tablet (VXA-CoV2-3.3) against approved mRNA booster shots in about 5,500 adults who have already been vaccinated. The goal is to see if the tablet can prevent symptomatic COVID-19 as well as or better than the injectable vaccine. Participants will be randomly assigned to receive either the oral tablet or an mRNA booster, and researchers will track infections and side effects for up to a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: oral SARS-CoV-2 vaccine tablet (VXA-CoV2-3.3, KP.2 strain)
What this could lead to: If successful, this could offer a needle-free, easier-to-store COVID-19 booster option that may be more acceptable to people who avoid injections.
What could go wrong: This is a mid-stage trial, so the oral vaccine may not prove as effective as mRNA shots. Side effects or immune response differences could limit its use.

Why investors are watching

Vaxart is testing an oral COVID-19 vaccine tablet against a standard mRNA booster in a 5,485-person phase 2b trial. For a micro-cap company with no approved products, this readout is the main event: a positive result would show its tablet can protect against a current variant, while a negative one would leave the company without a clear path forward.

If it works: If the oral vaccine matches or beats the mRNA booster, Vaxart could have a product that is easier to store and administer, which might attract partners or buyers. That outcome would validate its technology and give the company a real asset.

If it fails: Trials fail often, and this one compares directly against a proven vaccine, so the bar is high. A failure or delay could leave Vaxart with no approved product and little reason for investors to stay.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 5,485 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults 18 years of age and above, at time of screening. 2. Completed primary approved/authorized COVID-19 vaccination series and have received ≥ 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. 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 trials (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 antigen Covid test at the screening visit and on Day 1 prior to vaccine dosing. An indeterminate should be considered as positive for the purposes of screen-failing participants. 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: 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). Gout managed only for elevated uric acid without gout flares would not be exclusionary, provided no prohibited medications were used. 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 if any of the following is met: History of severe or uncontrolled gastroesophageal reflux disease (GERD) at any point during this period History of complicated GERD at any point during this period Was on treatment for 12 continuous weeks at any point during this period Has been with chronic or frequent GERD symptoms (e.g., more than twice per week) in the past year * peptic ulcer if any of the following is met: History of severe or uncontrolled peptic ulcer at any point during this period History of complicated peptic ulcer at any point during this period Was on treatment for 12 continuous weeks at any point during this period Has been with chronic or frequent peptic ulcer symptoms (e.g., more than twice per week) in the past year * cholecystectomy, if any of the following is met: Procedure was performed within 1 year of dosing, or The participant has ongoing/unresolved post-cholecystectomy digestive symptoms within 30 days prior to dosing 15. Use of oral or parenterally administered 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. The participant may resume GLP-1 receptor agonists only if all solicited symptoms have completely resolved, with the earliest restart date being Day 9. 17. Daily use (2 or more consecutive days) of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration through Day 8 (7 days post-vaccination). Low dose daily ASA ≤ 100 mg for cardio-protection is not exclusionary. 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. Confirmation of positive results with molecular testing is not required. 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 in case of occasional marijuana use. Chronic marijuana use (as determined by the investigator's discretion) or a known history of marijuana abuse in the setting of a positive test is exclusionary. 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 with the Medical Monitor's approval. 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. A personal history of stroke, myocardial infarction, or similar condition may not be exclusionary if the participant is medically stable and not receiving a prohibited medication such as an anticoagulant or thrombolytic (low dose prophylactic aspirin is permitted) 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, excision/ biopsy of cutaneous lesions or other procedures that do not require general anesthetic and/or prolonged immobility * 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 (low dose aspirin is permitted) * 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).

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 SARS-COV2

Contacts and locations

Locations

AMR - El Dorado - Heartland Research Associates

El Dorado, Kansas, 67042, United States
AMR - Fort Myers - Clinical Physiology Associates

Fort Myers, Florida, 33912, United States
AMR - Lexington (Central Kentucky Research Associates)

Lexington, Kentucky, 40509, United States
AMR - Miami (Clinical Research of South Florida)

Coral Gables, Florida, 33134, United States
AMR - New Orleans - Center for Clinical Research

New Orleans, Louisiana, 70119, United States
AMR - Newton (Heartland Research Associates)

Newton, Kansas, 67114, United States
AMR - Norfolk (Clinical Research Associates of Tidewater)

Norfolk, Virginia, 23502, United States
AMR - Wichita East - Heartland Research Associates

Wichita, Kansas, 67207, United States
AMR - Wichita West - Heartland Research Associates

Wichita, Kansas, 67205, United States
AXCES Research & Health - Santa Fe

Santa Fe, New Mexico, 87505, United States
Accel Research Sites (ARS) - St. Petersburg - Largo

Largo, Florida, 33777, United States
Accel Research Sites - Lakeland

Lakeland, Florida, 33803, United States
Accel Research Sites - Maitland

Maitland, Florida, 32751, United States
Accellacare - Charleston

Mt. Pleasant, South Carolina, 29464, United States
Accellacare - Duly Health and Care

Lombard, Illinois, 60148, United States
Accellacare - Hickory

Hickory, North Carolina, 28601, United States
Accellacare - McFarland Clinic

Ames, Iowa, 50010, United States
Accellacare - PMG Research of Bristol

Bristol, Tennessee, 37620, United States
Accellacare - Piedmont Healthcare

Statesville, North Carolina, 28625, United States
Accellacare - Raleigh

Raleigh, North Carolina, 27609, United States
Accellacare - Rocky Mount

Rocky Mount, North Carolina, 27804, United States
Accellacare - Salisbury

Salisbury, North Carolina, 28144, United States
Accellacare - Tradd Court

Wilmington, North Carolina, 28401, United States
Accellacare - Winston-Salem

Winston-Salem, North Carolina, 27103, United States
Accellacare of Knoxville

Knoxville, Tennessee, 37912, United States
Alliance for Multispecialty Research (AMR) - Corporate

Knoxville, Tennessee, 37909, United States
Altasciences Los Angeles (Formerly WCCT Global)

Cypress, California, 90630, United States
Ark Clinical Research - Fountain Valley, CA

Fountain Valley, California, 92708, United States
Ark Clinical Research - Long Beach, CA

Long Beach, California, 90815, United States
Atlas Clinical Research - Rochester Clinical Research

Rochester, New York, 14609, United States
Atlas Clinical Research - Suburban Research Associates - Media Office

Media, Pennsylvania, 19063, United States
Atlas Clinical Research - Suncoast Clinical Research - Pasco County

New Port Richey, Florida, 34652, United States
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States
Avacare (CCT) - Advanced Primary and Geriatric Care

Rockville, Maryland, 20850, United States
Avacare (CCT) - Clay Platte Family Medicine Clinic

Kansas City, Missouri, 64151, United States
Avacare (CCT) - Fiel Family & Sports Medicine

Tempe, Arizona, 85283, United States
Avacare (CCT) - Hatboro Medical Associates

Hatboro, Pennsylvania, 19040, United States
Avacare (CCT) - Lifeline Primary Care

Lilburn, Georgia, 30047, United States
Avacare (CCT) - Ogden Clinic - Grand View

Roy, Utah, 84067, United States
Avacare (CCT) - Olympus Family Medicine

Salt Lake City, Utah, 84117, United States
Avacare (CCT) - Skyline Medical Center

Elkhorn, Nebraska, 68022, United States
Avacare - Benchmark Research - Metairie

Metairie, Louisiana, 70006, United States
Avacare - Benchmark Research - New Orleans-North Shore

Covington, Louisiana, 70433, United States
Avacare - Benchmark Research - SOCAL-Colton

Colton, California, 92324, United States
Avacare - Benchmark Research - Sacramento

Sacramento, California, 95864, United States
Avacare - Benchmark Research Fort Worth

Fort Worth, Texas, 76135, United States
Avacare - Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, 80228, United States
Avacare - Lenzmeier Family Medicine

Glendale, Arizona, 85308, United States
Baptist Health Center for Clinical Research - Little Rock

Little Rock, Arkansas, 72205, United States
Be Well Clinical Studies - Nebraska

Lincoln, Nebraska, 68516, United States
Biscayne Clinical Research

North Miami Beach, Florida, 33169, United States
Boca Raton Clinical Research (BRCR) Global - Weston

Plantation, Florida, 33322, United States
Boca Raton Clinical Research (BRCR) Global USA - New Orleans

Gretna, Louisiana, 70053, United States
CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States
Cary Medical Group

Cary, North Carolina, 27518, United States
Cedar Health Research - Arlington/Euless

Euless, Texas, 76040, United States
Centricity Research (IACT Health) - Suffolk Primary Care

Suffolk, Virginia, 23435, United States
Chase Medical Research

Waterbury, Connecticut, 06708, United States
Coastal Clinical Research

Mobile, Alabama, 36608, United States
Core Clinical Trials - Central Alabama Research LLC

Birmingham, Alabama, 35209-8401, United States
DM Clinical Research - CyFair Clinical Research Center

Houston, Texas, 77065, United States
DM Clinical Research - Jersey City

Jersey City, New Jersey, 07306, United States
DM Clinical Research - Tomball - Multiple Specialties

Tomball, Texas, 77375, United States
Desert Clinical Research

Mesa, Arizona, 85213, United States
ENCORE - Nature Coast Clinical Research Inverness

Inverness, Florida, 34452, United States
ENCORE - St. Johns Center for Clinical Research

Saint Augustine, Florida, 32086, United States
ENCORE - Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States
Elite Research Network (ERN) - Legacy Clinical Trials

Colorado Springs, Colorado, 80909, United States
Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group

Cerritos, California, 90703, United States
EmVenio Research - Fort Worth, TX

Fort Worth, Texas, 76134, United States
Fleming Island Center For Clinical Research

Fleming Island, Florida, 32003, United States
Foothills Research Center

Phoenix, Arizona, 85044, United States
Headlands Research - JEM Research - Lake Worth

Lake Worth, Florida, 33462, United States
Health Research of Hampton Roads

Newport News, Virginia, 23606, United States
IMA Clinical Research - Albany, Suite 202

Albany, New York, 12205, United States
IMA Clinical Research - Austin

Austin, Texas, 78745, United States
IMA Clinical Research - Chicago

Chicago, Illinois, 60602, United States
IMA Clinical Research - Manhattan

New York, New York, 10036, United States
IMA Clinical Research - St. Petersburg

St. Petersburg, Florida, 33704, United States
Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States
Javara Research - Mankato Clinic

Mankato, Minnesota, 56001, United States
Javara Research - Privia Medical Group Georgia

Fayetteville, Georgia, 30214, United States
Javara Research - Privia Medical Group Mid-Atlantic - Annapolis

Annapolis, Maryland, 21401, United States
Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States
K2 Medical Research - Maitland

Maitland, Florida, 32751, United States
K2 Medical Research - South Orlando

Orlando, Florida, 32806, United States
Northern California Research

Sacramento, California, 95821, United States
Orion Clinical Research

Austin, Texas, 78759, United States
PanAmerican Clinical Research - Brownsville, Levee Street

Brownsville, Texas, 78520, United States
Paradigm Clinical Research - Wheat Ridge

Wheat Ridge, Colorado, 80033, United States
Pharmaron

Baltimore, Maryland, 21201, United States
Pinnacle Research Group

Anniston, Alabama, 36207, United States
Privia Health - SouthCoast Health

Fayetteville, Georgia, 30214, United States
SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates

Miami, Florida, 33173, United States
South Ogden Family Medicine

South Ogden, Utah, 84405, United States
Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States
Tekton Research - Austin

Austin, Texas, 78745, United States
Tekton Research - Beaumont

Beaumont, Texas, 77706, United States
Tekton Research - Colorado - Longmont

Longmont, Colorado, 80501, United States
Tekton Research - Delaware Pointe

Tulsa, Oklahoma, 74137, United States
Tekton Research - Fort Collins

Fort Collins, Colorado, 80528, United States
Tekton Research - Fredericksburg Road

San Antonio, Texas, 78229, United States
Tekton Research - Oklahoma - Magnolia Court

Moore, Oklahoma, 73160, United States
Tekton Research - Oklahoma - Primary Health Partners

Yukon, Oklahoma, 73099, United States
Trial Management Associates - Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States
Universal Axon Clinical Research

Doral, Florida, 33166, United States
Velocity (Meridian) Clinical Research - Baton Rouge

Baton Rouge, Louisiana, 70809, United States
Velocity (Meridian) Clinical Research - Grand Island

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

Omaha, Nebraska, 68134, United States
Velocity (Meridian) Clinical Research - Rockville

Rockville, Maryland, 20854, United States
Velocity (Meridian) Clinical Research - Sioux City

Sioux City, Iowa, 51106, United States
Velocity Clinical Research (National Research Institute) - Panorama City

Los Angeles, California, 90057, United States
Velocity Clinical Research - Abilene

Abilene, Texas, 79606, United States
Velocity Clinical Research - Alburquerque

Albuquerque, New Mexico, 87107, United States
Velocity Clinical Research - Anderson

Anderson, South Carolina, 29621, United States
Velocity Clinical Research - Austin

Austin, Texas, 78759, United States
Velocity Clinical Research - Boise (Meridian)

Meridian, Idaho, 83642, United States
Velocity Clinical Research - Charleston

Charleston, South Carolina, 29414, United States
Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)

Chula Vista, California, 91911, United States
Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)

Cincinnati, Ohio, 45242, United States
Velocity Clinical Research - Cleveland (Rapid Medical Research)

Beachwood, Ohio, 44122, United States
Velocity Clinical Research - Columbia (VitaLink)

Columbia, South Carolina, 29204, United States
Velocity Clinical Research - Durham

Durham, North Carolina, 27701, United States
Velocity Clinical Research - Gardena

Santa Ana, California, 92704, United States
Velocity Clinical Research - Grants Pass

Grants Pass, Oregon, 97527, United States
Velocity Clinical Research - Hallandale Beach (MD Clinical)

Hallandale, Florida, 33009, United States
Velocity Clinical Research - MedPharmics - Covington

Covington, Louisiana, 70433, United States
Velocity Clinical Research - MedPharmics - Gulfport

Gulfport, Mississippi, 39503, United States
Velocity Clinical Research - MedPharmics - Lafayette

Lafayette, Louisiana, 70508, United States
Velocity Clinical Research - MedPharmics - Phoenix

Phoenix, Arizona, 85020, United States
Velocity Clinical Research - Medford

Spokane, Washington, 99204, United States
Velocity Clinical Research - New Smyrna Beach

Edgewater, Florida, 32132, United States
Velocity Clinical Research - Providence (East Greenwich)

East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research - San Diego (eStudySite - La Mesa)

La Mesa, California, 91942, United States
Velocity Clinical Research - Savannah

Savannah, Georgia, 31406, United States
Velocity Clinical Research - Spokane

Spokane, Washington, 99204, United States
Velocity Clinical Research - Syracuse

East Syracuse, New York, 13057, United States
Velocity Clinical Research - Union (Vitalink)

Union, South Carolina, 29379, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)

Valparaiso, Indiana, 46383, United States
Velocity Clinical Research - Waco (formerly: Impact Research Institute)

Waco, Texas, 76710, United States
Velocity Clinical Research - Washington DC

Washington D.C., District of Columbia, 20016, United States
hyperCORE - ActivMed Practices and Research - Portsmouth

Portsmouth, New Hampshire, 03801, United States
hyperCORE - Centricity Research (IACT Health) - Rincon

Rincon, Georgia, 31326, United States
hyperCORE - Centricity Research Columbus

Columbus, Georgia, 31904, United States
hyperCORE International - Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

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