A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection
A Phase 2b, Double-Blind, Multi-Center, Randomized, Comparator-Controlled Trial to Determine the Relative Efficacy, Safety, and Immunogenicity of the Investigational Oral SARS-CoV-2 Vaccine Tablet Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection
1 other identifier
interventional
10,400
1 country
145
Brief Summary
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-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2024
CompletedFirst Submitted
Initial submission to the registry
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
October 22, 2025
October 1, 2025
2.1 years
November 1, 2024
October 20, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic Polymerase Chain Reaction (PCR)-Positive COVID-19 at 14 Days Post-vaccination
Up to approximately Day 14
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 at 12 Months Post-vaccination
Up to approximately 12 months
XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination
Up to approximately Day 7
XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination
Up to approximately Day 7
XBB Sentinel Cohorts: Percentage of Participants who Experience Unsolicited Adverse Events (AEs) Through 30 Days Post-vaccination
Up to approximately Day 30
XBB Sentinel Cohorts: Percentage of Participants who Experience Treatment-emergent Adverse Events (TEAEs) Through 12 Months Post-vaccination
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. An AE of special interest (AESI) is an AE (serious or non-serious) of scientific and medical concern specific to the sponsor's product or program. Medically attended AEs (MAAEs) are defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic. A serious TEAE (SAE) is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Up to approximately 12 months
XBB Sentinel Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination
Up to approximately Day 7
Secondary Outcomes (23)
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 Within 14 Days and 12 Months Post-vaccination in Participants with Specified Body Mass Index (BMI)
Up to approximately 12 months
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 0 and 6 Months Post-vaccination
Up to approximately 6 months
KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 6 and 12 Months Post-vaccination
Up to approximately 12 months
KP.2 Cohorts: Number of Participants with First Occurrence of Asymptomatic PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination
Up to approximately 12 months
KP.2 Cohorts: Number of Participants with First Occurrence of Severe PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination
Up to approximately 12 months
- +18 more secondary outcomes
Study Arms (4)
VXA-CoV2-3.1 Safety Sentinel Cohort
EXPERIMENTALParticipants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 (XBB.1.5 vaccine) tablet oral vaccine.
COMIRNATY® Safety Sentinel Cohort
ACTIVE COMPARATORParticipants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® (variant matched vaccine 2023-2024 formula) injectable COVID-19 vaccine.
VXA-CoV2-3.3
EXPERIMENTALIf no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of VXA-CoV2-3.3 (KP.2 vaccine).
COMIRNATY®
ACTIVE COMPARATORIf no dose-related toxicities are observed, and upon the recommendation of the Data and Safety Monitoring Board following review of Day 31 safety data in the initial safety cohorts (and possibly immunogenicity data), enrollment will continue with the remaining participants who will be randomized to receive a single dose of 2024-2025 formula of COMIRNATY® mRNA COVID-19 injectable vaccine.
Interventions
Intramuscular (IM) injection.
Eligibility Criteria
You may qualify if:
- Adults 18 years of age and above, at time of screening.
- Completed primary approved/authorized COVID-19 vaccination series with ≥ 2 mRNA vaccine doses.
- Last COVID-19 vaccine received ≥6 months prior to study vaccination.
- 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.
- 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.
- 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.
- Agree to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, PrEP) during participation in the study.
- Willing and able to provide informed consent prior to initiation of study procedures.
- 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.
- Negative rapid molecular Covid test at the screening visit and on Day 1 prior to vaccine dosing.
You may not qualify if:
- 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:
- 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.
- Presence of a fever ≥ 38.0°C (100.4°F) measured orally at baseline, on Day 1 prior to vaccination.
- Receipt of antipyretic/analgesic medications within 24 hours prior to vaccine administration.
- Participant has had a positive COVID test within 90 days prior to screening.
- Current or planned participation in any other interventional clinical trial.
- Participation in research involving any investigational product within 45 days prior to study vaccination.
- Receipt of any approved or authorized products intended to prevent SARS-CoV2 infection within 6 months prior to study vaccination.
- Receipt or donation of blood products or immunoglobulins within 60 days prior to enrollment or planned administration during the study.
- Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination.
- 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).
- 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.
- Administration of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within the following timeframes:
- B-cell therapies within the 6 months prior to first study vaccination
- Prednisone, ≥20 mg for more than 2 weeks, within the 30 days prior to study vaccination
- +45 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vaxartlead
Study Sites (145)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Core Clinical Trials - Central Alabama Research LLC
Birmingham, Alabama, 35209-8401, United States
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Avacare - Lenzmeier Family Medicine
Glendale, Arizona, 85308, United States
Desert Clinical Research
Mesa, Arizona, 85213, United States
Velocity Clinical Research - MedPharmics - Phoenix
Phoenix, Arizona, 85020, United States
Foothills Research Center
Phoenix, Arizona, 85044, United States
Avacare (CCT) - Fiel Family & Sports Medicine
Tempe, Arizona, 85283, United States
Baptist Health Center for Clinical Research - Little Rock
Little Rock, Arkansas, 72205, United States
Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group
Cerritos, California, 90703, United States
Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)
Chula Vista, California, 91911, United States
Avacare - Benchmark Research - SOCAL-Colton
Colton, California, 92324, 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
Velocity Clinical Research - San Diego (eStudySite - La Mesa)
La Mesa, California, 91942, United States
Ark Clinical Research - Long Beach, CA
Long Beach, California, 90815, United States
Velocity Clinical Research (National Research Institute) - Panorama City
Los Angeles, California, 90057, United States
Northern California Research
Sacramento, California, 95821, United States
Avacare - Benchmark Research - Sacramento
Sacramento, California, 95864, United States
Velocity Clinical Research - Gardena
Santa Ana, California, 92704, United States
Elite Research Network (ERN) - Legacy Clinical Trials
Colorado Springs, Colorado, 80909, United States
Tekton Research - Fort Collins
Fort Collins, Colorado, 80528, United States
Avacare - Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, 80228, United States
Tekton Research - Colorado - Longmont
Longmont, Colorado, 80501, United States
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado, 80033, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Chase Medical Research
Waterbury, Connecticut, 06708, United States
Velocity Clinical Research - Washington DC
Washington D.C., District of Columbia, 20016, United States
AMR - Miami (Clinical Research of South Florida)
Coral Gables, Florida, 33134, United States
Universal Axon Clinical Research
Doral, Florida, 33166, United States
Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, 32132, United States
Fleming Island Center For Clinical Research
Fleming Island, Florida, 32003, United States
AMR - Fort Myers - Clinical Physiology Associates
Fort Myers, Florida, 33912, United States
Velocity Clinical Research - Hallandale Beach (MD Clinical)
Hallandale, Florida, 33009, United States
ENCORE - Nature Coast Clinical Research Inverness
Inverness, Florida, 34452, United States
ENCORE - Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Headlands Research - JEM Research - Lake Worth
Lake Worth, Florida, 33462, United States
Accel Research Sites - Lakeland
Lakeland, Florida, 33803, United States
Accel Research Sites (ARS) - St. Petersburg - Largo
Largo, Florida, 33777, United States
Accel Research Sites - Maitland
Maitland, Florida, 32751, United States
K2 Medical Research - Maitland
Maitland, Florida, 32751, United States
SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates
Miami, Florida, 33173, United States
Atlas Clinical Research - Suncoast Clinical Research - Pasco County
New Port Richey, Florida, 34652, United States
Biscayne Clinical Research
North Miami Beach, Florida, 33169, United States
K2 Medical Research - South Orlando
Orlando, Florida, 32806, United States
Boca Raton Clinical Research (BRCR) Global - Weston
Plantation, Florida, 33322, United States
ENCORE - St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086, United States
IMA Clinical Research - St. Petersburg
St. Petersburg, Florida, 33704, United States
hyperCORE - Centricity Research Columbus
Columbus, Georgia, 31904, United States
Javara Research - Privia Medical Group Georgia
Fayetteville, Georgia, 30214, United States
Privia Health - SouthCoast Health
Fayetteville, Georgia, 30214, United States
Avacare (CCT) - Lifeline Primary Care
Lilburn, Georgia, 30047, United States
hyperCORE - Centricity Research (IACT Health) - Rincon
Rincon, Georgia, 31326, United States
Velocity Clinical Research - Savannah
Savannah, Georgia, 31406, United States
Velocity Clinical Research - Boise (Meridian)
Meridian, Idaho, 83642, United States
IMA Clinical Research - Chicago
Chicago, Illinois, 60602, United States
Accellacare - Duly Health and Care
Lombard, Illinois, 60148, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
Valparaiso, Indiana, 46383, United States
Accellacare - McFarland Clinic
Ames, Iowa, 50010, United States
Velocity (Meridian) Clinical Research - Sioux City
Sioux City, Iowa, 51106, United States
AMR - El Dorado - Heartland Research Associates
El Dorado, Kansas, 67042, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
AMR - Newton (Heartland Research Associates)
Newton, Kansas, 67114, United States
AMR - Wichita West - Heartland Research Associates
Wichita, Kansas, 67205, United States
AMR - Wichita East - Heartland Research Associates
Wichita, Kansas, 67207, United States
AMR - Lexington (Central Kentucky Research Associates)
Lexington, Kentucky, 40509, United States
Velocity (Meridian) Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Avacare - Benchmark Research - New Orleans-North Shore
Covington, Louisiana, 70433, United States
Velocity Clinical Research - MedPharmics - Covington
Covington, Louisiana, 70433, United States
Boca Raton Clinical Research (BRCR) Global USA - New Orleans
Gretna, Louisiana, 70053, United States
Velocity Clinical Research - MedPharmics - Lafayette
Lafayette, Louisiana, 70508, United States
Avacare - Benchmark Research - Metairie
Metairie, Louisiana, 70006, United States
AMR - New Orleans - Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Javara Research - Privia Medical Group Mid-Atlantic - Annapolis
Annapolis, Maryland, 21401, United States
Pharmaron
Baltimore, Maryland, 21201, United States
Avacare (CCT) - Advanced Primary and Geriatric Care
Rockville, Maryland, 20850, United States
Velocity (Meridian) Clinical Research - Rockville
Rockville, Maryland, 20854, United States
Javara Research - Mankato Clinic
Mankato, Minnesota, 56001, United States
Velocity Clinical Research - MedPharmics - Gulfport
Gulfport, Mississippi, 39503, United States
Avacare (CCT) - Clay Platte Family Medicine Clinic
Kansas City, Missouri, 64151, United States
Avacare (CCT) - Skyline Medical Center
Elkhorn, Nebraska, 68022, United States
Velocity (Meridian) Clinical Research - Grand Island
Grand Island, Nebraska, 68803, United States
Be Well Clinical Studies - Nebraska
Lincoln, Nebraska, 68516, United States
Velocity (Meridian) Clinical Research - Omaha
Omaha, Nebraska, 68134, United States
hyperCORE - ActivMed Practices and Research - Portsmouth
Portsmouth, New Hampshire, 03801, United States
DM Clinical Research - Jersey City
Jersey City, New Jersey, 07306, United States
Velocity Clinical Research - Alburquerque
Albuquerque, New Mexico, 87107, United States
AXCES Research & Health - Santa Fe
Santa Fe, New Mexico, 87505, United States
IMA Clinical Research - Albany, Suite 202
Albany, New York, 12205, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057, United States
IMA Clinical Research - Manhattan
New York, New York, 10036, United States
Atlas Clinical Research - Rochester Clinical Research
Rochester, New York, 14609, United States
Cary Medical Group
Cary, North Carolina, 27518, United States
Velocity Clinical Research - Durham
Durham, North Carolina, 27701, United States
Accellacare - Hickory
Hickory, North Carolina, 28601, 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 - Piedmont Healthcare
Statesville, North Carolina, 28625, United States
Accellacare - Tradd Court
Wilmington, North Carolina, 28401, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
Velocity Clinical Research - Cleveland (Rapid Medical Research)
Beachwood, Ohio, 44122, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)
Cincinnati, Ohio, 45242, United States
Tekton Research - Oklahoma - Magnolia Court
Moore, Oklahoma, 73160, United States
Tekton Research - Delaware Pointe
Tulsa, Oklahoma, 74137, United States
Tekton Research - Oklahoma - Primary Health Partners
Yukon, Oklahoma, 73099, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97527, United States
Avacare (CCT) - Hatboro Medical Associates
Hatboro, Pennsylvania, 19040, United States
Atlas Clinical Research - Suburban Research Associates - Media Office
Media, Pennsylvania, 19063, United States
Velocity Clinical Research - Providence (East Greenwich)
East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research - Anderson
Anderson, South Carolina, 29621, United States
Velocity Clinical Research - Charleston
Charleston, South Carolina, 29414, United States
Velocity Clinical Research - Columbia (VitaLink)
Columbia, South Carolina, 29204, United States
Accellacare - Charleston
Mt. Pleasant, South Carolina, 29464, United States
Trial Management Associates - Myrtle Beach
Myrtle Beach, South Carolina, 29572, United States
hyperCORE International - Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Velocity Clinical Research - Union (Vitalink)
Union, South Carolina, 29379, United States
Accellacare - PMG Research of Bristol
Bristol, Tennessee, 37620, United States
Alliance for Multispecialty Research (AMR) - Corporate
Knoxville, Tennessee, 37909, United States
Accellacare of Knoxville
Knoxville, Tennessee, 37912, United States
Velocity Clinical Research - Abilene
Abilene, Texas, 79606, United States
IMA Clinical Research - Austin
Austin, Texas, 78745, United States
Tekton Research - Austin
Austin, Texas, 78745, United States
Orion Clinical Research
Austin, Texas, 78759, United States
Velocity Clinical Research - Austin
Austin, Texas, 78759, United States
Tekton Research - Beaumont
Beaumont, Texas, 77706, United States
PanAmerican Clinical Research - Brownsville, Levee Street
Brownsville, Texas, 78520, United States
Cedar Health Research - Arlington/Euless
Euless, Texas, 76040, United States
EmVenio Research - Fort Worth, TX
Fort Worth, Texas, 76134, United States
Avacare - Benchmark Research Fort Worth
Fort Worth, Texas, 76135, United States
DM Clinical Research - CyFair Clinical Research Center
Houston, Texas, 77065, United States
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78229, United States
DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas, 77375, United States
Velocity Clinical Research - Waco (formerly: Impact Research Institute)
Waco, Texas, 76710, 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
South Ogden Family Medicine
South Ogden, Utah, 84405, United States
Health Research of Hampton Roads
Newport News, Virginia, 23606, United States
AMR - Norfolk (Clinical Research Associates of Tidewater)
Norfolk, Virginia, 23502, United States
Centricity Research (IACT Health) - Suffolk Primary Care
Suffolk, Virginia, 23435, United States
Velocity Clinical Research - Medford
Spokane, Washington, 99204, United States
Velocity Clinical Research - Spokane
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Cummings, MD
Vaxart, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2024
First Posted
November 4, 2024
Study Start
October 8, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
October 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share