AzTrials
AzTrials

SARS-CoV2Phase 2NCT06672055

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 2 study testing VXA-CoV2-3.1, COMIRNATY® and VXA-CoV2-3.3 in people with SARS-CoV2 and COVID-19, run by Vaxart at 145 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV2, COVID-19
What is being tested?
VXA-CoV2-3.1, COMIRNATY® and VXA-CoV2-3.3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,485 participants
Where
145 sitesUnited States
Study dates
8 Oct 2024to May 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults 18 years of age and above, at time of screening.
  • Completed primary approved/authorized COVID-19 vaccination series and have received ≥ 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 last 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.
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  • Agree to not participate in any other SARS-CoV-2 infection prevention trials (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 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.

Who cannot join

  • 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:
  • 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.
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  • 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). Gout managed only for elevated uric acid without gout flares would not be exclusionary, provided no prohibited medications were used.
  • 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
  • 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.
  • Any medication for any period of time that, in the opinion of the site investigator, could impede immune response to vaccination.
  • Use of any dose montelukast OR inhaled, intranasal, intra-articular, or systemic corticosteroids within 2 weeks prior to study vaccination.
  • Planned use of any of the above medications during the study.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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:
  • Any history of:
  • GI malignancy
  • malabsorption
  • pancreatobiliary disorders
  • inflammatory bowel disease
  • irritable bowel disease
  • hiatal hernia
  • surgical resection
  • 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
  • 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.
  • 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.
  • 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.
  • Personal or familial history of hypercoagulable states to include personal past history of deep vein thrombosis (DVT).
  • Personal history of myocarditis or pericarditis.
  • 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.
  • History of drug, alcohol, or chemical abuse within 1 year of screening.
  • 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.
  • Cancer, or treatment for cancer, within the past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma).
  • History of any form of angioedema.
  • History of GI bleeding including hematochezia (blood in stool) or melena (black stool) of unknown etiology or that has not been evaluated.
  • Any history or conditions that may lead to a higher risk of clotting events and/or thrombocytopenia, including:
  • 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)
  • History of heparin-related thrombotic events, and/or receiving heparin treatments
  • History of autoimmune or inflammatory disease
  • 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.
  • 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.
  • Study team member or first-degree relative of any study team member (inclusive of sponsor and site personnel involved in the study).

Trial locations and contacts

145 sites in 1 country.

145 sites in 1 country

United States145 sites

  • Velocity Clinical Research - Abilene

    Abilene, Texas, 79606

  • IMA Clinical Research - Albany, Suite 202

    Albany, New York, 12205

  • Velocity Clinical Research - Alburquerque

    Albuquerque, New Mexico, 87107

  • Accellacare - McFarland Clinic

    Ames, Iowa, 50010

  • Velocity Clinical Research - Anderson

    Anderson, South Carolina, 29621

  • Javara Research - Privia Medical Group Mid-Atlantic - Annapolis

    Annapolis, Maryland, 21401

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • IMA Clinical Research - Austin

    Austin, Texas, 78745

  • Tekton Research - Austin

    Austin, Texas, 78745

  • Orion Clinical Research

    Austin, Texas, 78759

  • Velocity Clinical Research - Austin

    Austin, Texas, 78759

  • Pharmaron

    Baltimore, Maryland, 21201

  • Velocity (Meridian) Clinical Research - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Velocity Clinical Research - Cleveland (Rapid Medical Research)

    Beachwood, Ohio, 44122

  • Tekton Research - Beaumont

    Beaumont, Texas, 77706

  • Core Clinical Trials - Central Alabama Research LLC

    Birmingham, Alabama, 35209-8401

  • Accellacare - PMG Research of Bristol

    Bristol, Tennessee, 37620

  • PanAmerican Clinical Research - Brownsville, Levee Street

    Brownsville, Texas, 78520

  • Cary Medical Group

    Cary, North Carolina, 27518

  • Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group

    Cerritos, California, 90703

  • Velocity Clinical Research - Charleston

    Charleston, South Carolina, 29414

  • IMA Clinical Research - Chicago

    Chicago, Illinois, 60602

  • Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)

    Chula Vista, California, 91911

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)

    Cincinnati, Ohio, 45242

  • Elite Research Network (ERN) - Legacy Clinical Trials

    Colorado Springs, Colorado, 80909

  • Avacare - Benchmark Research - SOCAL-Colton

    Colton, California, 92324

  • Velocity Clinical Research - Columbia (VitaLink)

    Columbia, South Carolina, 29204

  • hyperCORE - Centricity Research Columbus

    Columbus, Georgia, 31904

  • AMR - Miami (Clinical Research of South Florida)

    Coral Gables, Florida, 33134

  • Avacare - Benchmark Research - New Orleans-North Shore

    Covington, Louisiana, 70433

  • Velocity Clinical Research - MedPharmics - Covington

    Covington, Louisiana, 70433

  • Altasciences Los Angeles (Formerly WCCT Global)

    Cypress, California, 90630

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • Velocity Clinical Research - Durham

    Durham, North Carolina, 27701

  • Velocity Clinical Research - Providence (East Greenwich)

    East Greenwich, Rhode Island, 02818

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057

  • Velocity Clinical Research - New Smyrna Beach

    Edgewater, Florida, 32132

  • AMR - El Dorado - Heartland Research Associates

    El Dorado, Kansas, 67042

  • Avacare (CCT) - Skyline Medical Center

    Elkhorn, Nebraska, 68022

  • Cedar Health Research - Arlington/Euless

    Euless, Texas, 76040

  • Javara Research - Privia Medical Group Georgia

    Fayetteville, Georgia, 30214

  • Privia Health - SouthCoast Health

    Fayetteville, Georgia, 30214

  • Fleming Island Center For Clinical Research

    Fleming Island, Florida, 32003

  • Tekton Research - Fort Collins

    Fort Collins, Colorado, 80528

  • AMR - Fort Myers - Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • EmVenio Research - Fort Worth, TX

    Fort Worth, Texas, 76134

  • Avacare - Benchmark Research Fort Worth

    Fort Worth, Texas, 76135

  • Ark Clinical Research - Fountain Valley, CA

    Fountain Valley, California, 92708

  • Avacare - Lenzmeier Family Medicine

    Glendale, Arizona, 85308

  • Velocity (Meridian) Clinical Research - Grand Island

    Grand Island, Nebraska, 68803

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon, 97527

  • Boca Raton Clinical Research (BRCR) Global USA - New Orleans

    Gretna, Louisiana, 70053

  • Velocity Clinical Research - MedPharmics - Gulfport

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research - Hallandale Beach (MD Clinical)

    Hallandale, Florida, 33009

  • Avacare (CCT) - Hatboro Medical Associates

    Hatboro, Pennsylvania, 19040

  • Accellacare - Hickory

    Hickory, North Carolina, 28601

  • DM Clinical Research - CyFair Clinical Research Center

    Houston, Texas, 77065

  • ENCORE - Nature Coast Clinical Research Inverness

    Inverness, Florida, 34452

  • ENCORE - Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • DM Clinical Research - Jersey City

    Jersey City, New Jersey, 07306

  • Avacare (CCT) - Clay Platte Family Medicine Clinic

    Kansas City, Missouri, 64151

  • Alliance for Multispecialty Research (AMR) - Corporate

    Knoxville, Tennessee, 37909

  • Accellacare of Knoxville

    Knoxville, Tennessee, 37912

  • Velocity Clinical Research - San Diego (eStudySite - La Mesa)

    La Mesa, California, 91942

  • Velocity Clinical Research - MedPharmics - Lafayette

    Lafayette, Louisiana, 70508

  • Headlands Research - JEM Research - Lake Worth

    Lake Worth, Florida, 33462

  • Accel Research Sites - Lakeland

    Lakeland, Florida, 33803

  • Avacare - Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado, 80228

  • Accel Research Sites (ARS) - St. Petersburg - Largo

    Largo, Florida, 33777

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

  • AMR - Lexington (Central Kentucky Research Associates)

    Lexington, Kentucky, 40509

  • Avacare (CCT) - Lifeline Primary Care

    Lilburn, Georgia, 30047

  • Be Well Clinical Studies - Nebraska

    Lincoln, Nebraska, 68516

  • Baptist Health Center for Clinical Research - Little Rock

    Little Rock, Arkansas, 72205

  • Accellacare - Duly Health and Care

    Lombard, Illinois, 60148

  • Ark Clinical Research - Long Beach, CA

    Long Beach, California, 90815

  • Tekton Research - Colorado - Longmont

    Longmont, Colorado, 80501

  • Velocity Clinical Research (National Research Institute) - Panorama City

    Los Angeles, California, 90057

  • Accel Research Sites - Maitland

    Maitland, Florida, 32751

  • K2 Medical Research - Maitland

    Maitland, Florida, 32751

  • Javara Research - Mankato Clinic

    Mankato, Minnesota, 56001

  • Atlas Clinical Research - Suburban Research Associates - Media Office

    Media, Pennsylvania, 19063

  • Velocity Clinical Research - Boise (Meridian)

    Meridian, Idaho, 83642

  • Desert Clinical Research

    Mesa, Arizona, 85213

  • Avacare - Benchmark Research - Metairie

    Metairie, Louisiana, 70006

  • SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates

    Miami, Florida, 33173

  • Coastal Clinical Research

    Mobile, Alabama, 36608

  • Tekton Research - Oklahoma - Magnolia Court

    Moore, Oklahoma, 73160

  • Accellacare - Charleston

    Mt. Pleasant, South Carolina, 29464

  • Trial Management Associates - Myrtle Beach

    Myrtle Beach, South Carolina, 29572

  • AMR - New Orleans - Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Atlas Clinical Research - Suncoast Clinical Research - Pasco County

    New Port Richey, Florida, 34652

  • IMA Clinical Research - Manhattan

    New York, New York, 10036

  • Health Research of Hampton Roads

    Newport News, Virginia, 23606

  • AMR - Newton (Heartland Research Associates)

    Newton, Kansas, 67114

  • AMR - Norfolk (Clinical Research Associates of Tidewater)

    Norfolk, Virginia, 23502

  • hyperCORE International - Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Biscayne Clinical Research

    North Miami Beach, Florida, 33169

  • Velocity (Meridian) Clinical Research - Omaha

    Omaha, Nebraska, 68134

  • K2 Medical Research - South Orlando

    Orlando, Florida, 32806

  • Velocity Clinical Research - MedPharmics - Phoenix

    Phoenix, Arizona, 85020

  • Foothills Research Center

    Phoenix, Arizona, 85044

  • Boca Raton Clinical Research (BRCR) Global - Weston

    Plantation, Florida, 33322

  • hyperCORE - ActivMed Practices and Research - Portsmouth

    Portsmouth, New Hampshire, 03801

  • Accellacare - Raleigh

    Raleigh, North Carolina, 27609

  • hyperCORE - Centricity Research (IACT Health) - Rincon

    Rincon, Georgia, 31326

  • Atlas Clinical Research - Rochester Clinical Research

    Rochester, New York, 14609

  • Avacare (CCT) - Advanced Primary and Geriatric Care

    Rockville, Maryland, 20850

  • Velocity (Meridian) Clinical Research - Rockville

    Rockville, Maryland, 20854

  • Accellacare - Rocky Mount

    Rocky Mount, North Carolina, 27804

  • Avacare (CCT) - Ogden Clinic - Grand View

    Roy, Utah, 84067

  • Northern California Research

    Sacramento, California, 95821

  • Avacare - Benchmark Research - Sacramento

    Sacramento, California, 95864

  • ENCORE - St. Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

  • Accellacare - Salisbury

    Salisbury, North Carolina, 28144

  • Avacare (CCT) - Olympus Family Medicine

    Salt Lake City, Utah, 84117

  • Tekton Research - Fredericksburg Road

    San Antonio, Texas, 78229

  • Velocity Clinical Research - Gardena

    Santa Ana, California, 92704

  • AXCES Research & Health - Santa Fe

    Santa Fe, New Mexico, 87505

  • Velocity Clinical Research - Savannah

    Savannah, Georgia, 31406

  • Velocity (Meridian) Clinical Research - Sioux City

    Sioux City, Iowa, 51106

  • South Ogden Family Medicine

    South Ogden, Utah, 84405

  • Velocity Clinical Research - Medford

    Spokane, Washington, 99204

  • Velocity Clinical Research - Spokane

    Spokane, Washington, 99204

  • IMA Clinical Research - St. Petersburg

    St. Petersburg, Florida, 33704

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Accellacare - Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Centricity Research (IACT Health) - Suffolk Primary Care

    Suffolk, Virginia, 23435

  • Avacare (CCT) - Fiel Family & Sports Medicine

    Tempe, Arizona, 85283

  • DM Clinical Research - Tomball - Multiple Specialties

    Tomball, Texas, 77375

  • Tekton Research - Delaware Pointe

    Tulsa, Oklahoma, 74137

  • Velocity Clinical Research - Union (Vitalink)

    Union, South Carolina, 29379

  • Velocity Clinical Research - Valparaiso (Buynak Clinical Research)

    Valparaiso, Indiana, 46383

  • Velocity Clinical Research - Waco (formerly: Impact Research Institute)

    Waco, Texas, 76710

  • Velocity Clinical Research - Washington DC

    Washington D.C., District of Columbia, 20016

  • Chase Medical Research

    Waterbury, Connecticut, 06708

  • Paradigm Clinical Research - Wheat Ridge

    Wheat Ridge, Colorado, 80033

  • AMR - Wichita West - Heartland Research Associates

    Wichita, Kansas, 67205

  • AMR - Wichita East - Heartland Research Associates

    Wichita, Kansas, 67207

  • Accellacare - Tradd Court

    Wilmington, North Carolina, 28401

  • Accellacare - Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Atrium Health Wake Forest Baptist - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

  • Tekton Research - Oklahoma - Primary Health Partners

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: 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

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.

Conditions
SARS-CoV2, COVID-19
Being tested
VXA-CoV2-3.1, COMIRNATY®, VXA-CoV2-3.3
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VXA-CoV2-3.1Biological

    Tablets for oral use.

  • COMIRNATY®Biological

    Also called Pfizer-BioNTech mRNA Vaccine

    Intramuscular (IM) injection.

  • VXA-CoV2-3.3Biological

    Tablets for oral use.

Study groups in NCT06672055
Study groupRoleWhat they receive
VXA-CoV2-3.1 Safety Sentinel CohortExperimentalParticipants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 (XBB.1.5 vaccine) tablet oral vaccine.
Receives: Biological: VXA-CoV2-3.1
COMIRNATY® Safety Sentinel CohortActive comparatorParticipants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® (variant matched vaccine 2023-2024 formula) injectable COVID-19 vaccine.
Receives: Biological: COMIRNATY®
VXA-CoV2-3.3ExperimentalIf 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).
Receives: Biological: VXA-CoV2-3.3
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.
Receives: Biological: COMIRNATY®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic Polymerase Chain Reaction (PCR)-Positive COVID-19 at 14 Days Post-vaccination

    Measured: Up to approximately Day 14

  2. KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 at 12 Months Post-vaccination

    Measured: Up to approximately 12 months

  3. XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination

    Measured: Up to approximately Day 7

  4. XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination

    Measured: Up to approximately Day 7

  5. XBB Sentinel Cohorts: Percentage of Participants who Experience Unsolicited Adverse Events (AEs) Through 30 Days Post-vaccination

    Measured: Up to approximately Day 30

  6. 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.

    Measured: Up to approximately 12 months

  7. XBB Sentinel Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination

    Measured: Up to approximately Day 7

Secondary outcomes (27)

  1. 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)

    Measured: Up to approximately 12 months

  2. KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 0 and 180 Days Post-vaccination

    Measured: Up to approximately 180 days

  3. KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 181 and 365 Days Post-vaccination

    Measured: Up to approximately 365 days

  4. KP.2 Cohorts: Number of Participants with First Occurrence of Confirmed Asymptomatic PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination from Self-administered at Home Tests

    Measured: Up to approximately 12 months

  5. KP.2 Cohorts: Number of Participants with First Occurrence of Presumptive Asymptomatic PCR-Positive COVID-19 from Self-administered at Home Tests

    Measured: Up to approximately 12 months

  6. KP.2 Cohorts: Number of Participants with First Occurrence of Severe PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination

    Measured: Up to approximately 12 months

  7. KP.2 Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination

    Measured: Up to approximately Day 7

  8. KP.2 Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination

    Measured: Up to approximately Day 7

  9. KP.2 Cohorts: Percentage of Participants who Experience Unsolicited AEs Through 30 Days Post-vaccination

    Measured: Up to approximately Day 30

  10. KP.2 Cohorts: Percentage of Participants who Experience 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 AESI is an AE (serious or non-serious) of scientific and medical concern specific to the sponsor's product or program. MAAEs are defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic. An 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.

    Measured: Up to approximately 12 months

  11. KP.2 Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination

    Measured: Up to approximately Day 7

  12. KP.2 Cohorts: Geometric Mean titer (GMT) of SARS-CoV-2 Specific Serum Neutralizing Antibodies (nAb) Post-vaccination

    Measured: Day 1 and Days 31, 91, 181, and 366

  13. KP.2 Cohorts: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Serum nAb Post-vaccination

    Measured: Day 1 and Days 31, 91, 181, and 366

  14. KP.2 Cohorts: Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Binding Antibody (bAb) Against Spike Protein (S) Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  15. KP.2 Cohorts: GMFR of Serum IgG Anti-S bAb Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  16. KP.2 Cohorts: GMC of Serum Immunoglobulin A (IgA) bAb Against S Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  17. KP.2 Cohorts: GMFR of Serum IgA Anti-S Specific bAb Post-vaccination

    Measured: Day 1 and Days 31, 91, 181, and 366

  18. KP.2 Cohorts: GMT of SARS-CoV-2 Specific Saliva nAb Post-vaccination

    Measured: Day 1 and Days 31, 91, 181, and 366

  19. KP.2 Cohorts: GMFR of SARS-CoV-2 Specific Saliva nAb Post-vaccination

    Measured: Day 1 and Days 31, 91, 181, and 366

  20. KP.2 Cohorts: GMC of S-specific Saliva IgA bAb Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  21. KP.2 Cohorts: GMFR of S-specific Saliva IgA bAb Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  22. KP.2 Cohorts: GMT of SARS-CoV-2 specific Nasal Lining Fluid (NLF) nAb Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  23. KP.2 Cohorts: GMFR of SARS-CoV-2 specific NLF nAb Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  24. KP.2 Cohorts: GMC of S-specific NLF IgA bAb Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  25. KP.2 Cohorts: GMFR of S-specific NLF IgA bAb Post-vaccination

    Measured: Days 1, 31, 91, 181, and 366

  26. KP.2 Cohorts: Percentage of Participants With 2, 3, and 4 Fold Rise in S-specific Serum IgG and IgA bAb, Serum nAb, Saliva IgA bAb, NLF IgA bAb, saliva nAb and NLF nAb Post-vaccination

    Measured: Day 1 and Days 31, 91, 181, and 366

  27. KP.2 Cohorts: Concentration of Intracellular T Cell Cytokine and Cell Surface Marker

    Measured: Days 1, 31, 91, 181, and 366

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study start8 Oct 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5,485 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06672055
Sponsor's protocol ID
VXA-COV-202
Other IDs
RRPV-24-04-NGVx-003
Status last verified
Oct 2026
First submitted
1 Nov 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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