RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-10-08

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06672055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Study Contact

Maria Apkarian

CONTACT

650-392-3109

ClinicalTrials@Vaxart.com

Nick D'Amato

CONTACT

650-392-3109

ClinicalTrials@Vaxart.com

Principal Investigator

James Cummings, MD

STUDY_DIRECTOR

Vaxart, Inc.

Study Locations (Sites)

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, 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 Beach, 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

Saint 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

Mount 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

Collaborators and Investigators

Sponsor: Vaxart

James Cummings, MD, STUDY_DIRECTOR, Vaxart, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-08

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-10-08

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

SARS-CoV2
COVID-19