Clinical trial NCT06672055: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: SARS-CoV2
COVID-19
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 10400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Adults 18 years of age and above, at time of screening.
2. Completed primary approved/authorized COVID-19 vaccination series with ≥ 2 mRNA vaccine doses.
3. Last COVID-19 vaccine received ≥6 months prior to study vaccination.
4. Male and female participants of childbearing potential must agree to consistently use a highly effective method of contraception from at least 30 days prior to enrollment and through 3 months after the study vaccination.
5. Male participants must refrain from sperm donation from the day of study vaccination through the end of the study. Female participants must refrain from egg donation at least 30 days prior to study vaccination through the end of the study.
6. Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination) with screening lab values within normal limits or abnormalities assessed as not clinically significant. Screening platelet count must be \>140,000/μL.
7. Agree to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, PrEP) during participation in the study.
8. Willing and able to provide informed consent prior to initiation of study procedures.
9. Available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.
10. Negative rapid molecular Covid test at the screening visit and on Day 1 prior to vaccine dosing.

Exclusion Criteria:

1. Participant has an acute illness as defined by any of the following (note: assessment may be repeated once during screening period) as determined by the site investigator, within 72 hours prior to vaccination as follows:

   1. An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol.
   2. Presence of a fever ≥ 38.0°C (100.4°F) measured orally at baseline, on Day 1 prior to vaccination.
   3. Receipt of antipyretic/analgesic medications within 24 hours prior to vaccine administration.
2. Participant has had a positive COVID test within 90 days prior to screening.
3. Current or planned participation in any other interventional clinical trial.
4. Participation in research involving any investigational product within 45 days prior to study vaccination.
5. Receipt of any approved or authorized products intended to prevent SARS-CoV2 infection within 6 months prior to study vaccination.
6. Receipt or donation of blood products or immunoglobulins within 60 days prior to enrollment or planned administration during the study.
7. Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination.
8. Any autoimmune or immunodeficiency disease/condition (including and not limited to untreated or advanced HIV infection with CD4 counts \<200 cells/mm\^3, history of AIDS defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV, severe combined immunodeficiency (SCID), hypogammaglobulinemia, asplenia or functional asplenia).
9. Unstable medical or psychiatric illness (acute or chronic illness) requiring significant medical monitoring and intervention during the 90 days prior to enrollment. Note: diabetes mellitus (Types 1 \& 2) are not excluded if assessed by the principal investigator (PI) as well-controlled.
10. Administration of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within the following timeframes:

    1. B-cell therapies within the 6 months prior to first study vaccination
    2. Prednisone, ≥20 mg for more than 2 weeks, within the 30 days prior to study vaccination
    3. Other medications in this category, including but not limited to high-dose inhaled corticosteroids (\>800 mcg/day of beclomethasone dipropionate or equivalent); antimetabolites; transplant immunosuppressive agents; alkylating agents; cell-depleting agents; or cancer chemotherapeutics, within the 90 days prior to study vaccination.
    4. Any medication for any period of time that, in the opinion of the site investigator, could impede immune response to vaccination.
    5. Use of any dose montelukast OR inhaled, intranasal, intra-articular, or systemic corticosteroids within 2 weeks prior to study vaccination.
    6. Planned use of any of the above medications during the study.
    7. Concomitant allergen immunotherapy (AIT) will be allowed only if the participant is stable in the maintenance phase of AIT. Maintenance AIT should not be dosed for at least 7 days before and 7 days after study vaccine dosing, and the PI must document the treating allergist's approval.
11. Known contraindication to IM injection or blood draws (e.g. bleeding diathesis, acquired coagulopathy, significant bleeding or bruising) or to oral route of administration (unable to swallow tablets).
12. Any known allergies to components contained in the investigational product or comparator or latex allergy (including polyethylene glycol \[PEG\] allergies) and/or history of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
13. Women who are pregnant (pregnancy tests will be performed at screening and prior to dosing), breastfeeding, or who plan to become pregnant during the study.
14. History of irritable bowel disease or other inflammatory digestive or gastrointestinal condition that could affect the distribution/safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine. Such conditions may include but are not limited to:

    1. Any history of:

       * GI malignancy
       * malabsorption
       * pancreatobiliary disorders
       * inflammatory bowel disease
       * irritable bowel disease
       * hiatal hernia
       * surgical resection
    2. History of diagnosis or treatment in past 5 years of:

       * esophageal or gastric motility disorder
       * gastroesophageal reflux disorder
       * peptic ulcer
       * cholecystectomy.
15. Use of antibiotics, proton pump inhibitors, H2 blockers, or antacids within 7 days prior to study drug administration or planned use from dosing through Day 31.
16. Use of drugs known to affect gastrointestinal motility including glucagon-like peptide 1 (GLP-1) receptor agonists including tirzepatide (Mounjaro) and semaglutide (Wegovy, Ozempic) within 30 days prior to drug administration.
17. Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the study.
18. Personal or familial history of hypercoagulable states to include personal past history of deep vein thrombosis (DVT).
19. Personal history of myocarditis or pericarditis.
20. Positive Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at the screening visit.
21. History of drug, alcohol, or chemical abuse within 1 year of screening.
22. Positive urine drug screen for drugs of abuse at screening (except for occasional marijuana use). Concurrent or planned use of marijuana from dosing through Day 31 is prohibited. Positive urine drug screen (UDS) at screening due to prescribed stimulants will be reviewed on a case by case basis.
23. Cancer, or treatment for cancer, within the past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma).
24. History of any form of angioedema.
25. History of GI bleeding including hematochezia (blood in stool) or melena (black stool) of unknown etiology or that has not been evaluated.
26. Any history or conditions that may lead to a higher risk of clotting events and/or thrombocytopenia, including:

    1. Familial coagulopathy or personal history of bleeding disorder or thrombosis
    2. History of heparin-related thrombotic events, and/or receiving heparin treatments
    3. History of autoimmune or inflammatory disease
    4. Presence of any of the following conditions known to increase the risk of thrombosis within 6 months prior to screening:

       * Recent surgery other than fully healed cesarean delivery or excision/ biopsy of cutaneous lesions
       * Immobility (confined to bed or wheelchair for 3 or more successive days)
       * Head trauma with loss of consciousness or documented brain injury
       * Receipt of anticoagulants for prophylaxis of thrombosis
       * Recent clinically significant infection including hospitalization for COVID-19 related illness.
27. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the investigational product or interpretation of study results.
28. Study team member or first-degree relative of any study team member (inclusive of sponsor and site personnel involved in the study).

Primary outcomes:
measure: KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic Polymerase Chain Reaction (PCR)-Positive COVID-19 at 14 Days Post-vaccination
timeFrame: Up to approximately Day 14
measure: KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 at 12 Months Post-vaccination
timeFrame: Up to approximately 12 months
measure: XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination
timeFrame: Up to approximately Day 7
measure: XBB Sentinel Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination
timeFrame: Up to approximately Day 7
measure: XBB Sentinel Cohorts: Percentage of Participants who Experience Unsolicited Adverse Events (AEs) Through 30 Days Post-vaccination
timeFrame: Up to approximately Day 30
measure: XBB Sentinel Cohorts: Percentage of Participants who Experience Treatment-emergent Adverse Events (TEAEs) Through 12 Months Post-vaccination
timeFrame: Up to approximately 12 months
measure: XBB Sentinel Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination
timeFrame: Up to approximately Day 7
Secondary outcomes:
measure: 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)
timeFrame: Up to approximately 12 months
measure: KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 0 and 6 Months Post-vaccination
timeFrame: Up to approximately 6 months
measure: KP.2 Cohorts: Percentage of Participants with First Occurrence of Symptomatic PCR-Positive COVID-19 within 6 and 12 Months Post-vaccination
timeFrame: Up to approximately 12 months
measure: KP.2 Cohorts: Number of Participants with First Occurrence of Asymptomatic PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination
timeFrame: Up to approximately 12 months
measure: KP.2 Cohorts: Number of Participants with First Occurrence of Severe PCR-Positive COVID-19 within 14 Days and 12 Months Post-vaccination
timeFrame: Up to approximately 12 months
measure: KP.2 Cohorts: Percentage of Participants who Experience any Solicited Local Reactogenicity Through 7 Days Post-vaccination
timeFrame: Up to approximately Day 7
measure: KP.2 Cohorts: Percentage of Participants who Experience any Solicited Systemic Reactogenicity Through 7 Days Post-vaccination
timeFrame: Up to approximately Day 7
measure: KP.2 Cohorts: Percentage of Participants who Experience Unsolicited AEs Through 30 Days Post-vaccination
timeFrame: Up to approximately Day 30
measure: KP.2 Cohorts: Percentage of Participants who Experience TEAEs Through 12 Months Post-vaccination
timeFrame: Up to approximately 12 months
measure: KP.2 Cohorts: Percentage of Participants With any Clinically Significant Abnormal Safety Laboratory Results Within 7 Days Pots-vaccination
timeFrame: Up to approximately Day 7
measure: KP.2 Cohorts: Concentration of SARS-CoV-2 Specific Serum Neutralizing Antibodies (nAb) Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Fold Rise of SARS-CoV-2 Specific Serum nAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Concentration of Serum Immunoglobulin G (IgG) Binding Antibody (bAb) Against Spike Protein (S) and Receptor Binding Domain (RBD) Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Fold Rise of Serum IgG Anti-S or RBD Specific bAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Concentration of Serum Immunoglobulin A (IgA) bAb Against S and RBD Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Fold Rise of Serum IgA Anti-S or RBD Specific bAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Concentration of S and RBD-specific Saliva IgA bAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Fold Rise of S and RBD-specific Saliva IgA bAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Concentration of S and RBD-specific Nasal Lining Fluid (NLF) IgA bAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Fold Rise of S and RBD-specific NLF IgA bAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Percentage of Participants With 2, 3, and 4 Fold Rise in S or RBD-Specific Serum IgG and IgA bAb, Serum nAb, Saliva IgA bAb, and NLF IgA bAb Post-vaccination
timeFrame: Day 1 and Months 1, 3, 6, and 12
measure: KP.2 Cohorts: Concentration of Intracellular T Cell Cytokine and Cell Surface Marker at Day 1 and 1 Month Post-vaccination
timeFrame: Day 1 and Month 1
measure: KP.2 Cohorts: Concentration of Intracellular T Cell Cytokine and Cell Surface Marker at 3, 6, and 12 Months Post-vaccination
timeFrame: Months 3, 6, and 12
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Birmingham
country: United States
facility: Core Clinical Trials - Central Alabama Research LLC
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Glendale
country: United States
facility: Avacare - Lenzmeier Family Medicine
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Velocity Clinical Research - MedPharmics - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center
state: Arizona
city: Tempe
country: United States
facility: Avacare (CCT) - Fiel Family & Sports Medicine
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research - Little Rock
state: Arkansas
city: Cerritos
country: United States
facility: Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)
state: California
city: Colton
country: United States
facility: Avacare - Benchmark Research - SOCAL-Colton
state: California
city: Cypress
country: United States
facility: Altasciences Los Angeles (Formerly WCCT Global)
state: California
city: Fountain Valley
country: United States
facility: Ark Clinical Research - Fountain Valley, CA
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research - San Diego (eStudySite - La Mesa)
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research - Long Beach, CA
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research (National Research Institute) - Panorama City
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Sacramento
country: United States
facility: Avacare - Benchmark Research - Sacramento
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research - Gardena
state: California
city: Colorado Springs
country: United States
facility: Elite Research Network (ERN) - Legacy Clinical Trials
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research - Fort Collins
state: Colorado
city: Lakewood
country: United States
facility: Avacare - Critical Care, Pulmonary and Sleep Associates
state: Colorado
city: Longmont
country: United States
facility: Tekton Research - Colorado - Longmont
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research - Wheat Ridge
state: Colorado
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research
state: Connecticut
city: Washington
country: United States
facility: Velocity Clinical Research - Washington DC
state: District of Columbia
city: Coral Gables
country: United States
facility: AMR - Miami (Clinical Research of South Florida)
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Edgewater
country: United States
facility: Velocity Clinical Research - New Smyrna Beach
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center For Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: AMR - Fort Myers - Clinical Physiology Associates
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach (MD Clinical)
state: Florida
city: Inverness
country: United States
facility: ENCORE - Nature Coast Clinical Research Inverness
state: Florida
city: Jacksonville
country: United States
facility: ENCORE - Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lake Worth
country: United States
facility: Headlands Research - JEM Research - Lake Worth
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites - Lakeland
state: Florida
city: Largo
country: United States
facility: Accel Research Sites (ARS) - St. Petersburg - Largo
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research - Maitland
state: Florida
city: Miami
country: United States
facility: SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates
state: Florida
city: New Port Richey
country: United States
facility: Atlas Clinical Research - Suncoast Clinical Research - Pasco County
state: Florida
city: North Miami Beach
country: United States
facility: Biscayne Clinical Research
state: Florida
city: Orlando
country: United States
facility: K2 Medical Research - South Orlando
state: Florida
city: Plantation
country: United States
facility: Boca Raton Clinical Research (BRCR) Global - Weston
state: Florida
city: Saint Augustine
country: United States
facility: ENCORE - St. Johns Center for Clinical Research
state: Florida
city: Saint Petersburg
country: United States
facility: IMA Clinical Research - St. Petersburg
state: Florida
city: Columbus
country: United States
facility: hyperCORE - Centricity Research Columbus
state: Georgia
city: Fayetteville
country: United States
facility: Javara Research - Privia Medical Group Georgia
state: Georgia
city: Fayetteville
country: United States
facility: Privia Health - SouthCoast Health
state: Georgia
city: Lilburn
country: United States
facility: Avacare (CCT) - Lifeline Primary Care
state: Georgia
city: Rincon
country: United States
facility: hyperCORE - Centricity Research (IACT Health) - Rincon
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research - Savannah
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise (Meridian)
state: Idaho
city: Chicago
country: United States
facility: IMA Clinical Research - Chicago
state: Illinois
city: Lombard
country: United States
facility: Accellacare - Duly Health and Care
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
state: Indiana
city: Ames
country: United States
facility: Accellacare - McFarland Clinic
state: Iowa
city: Sioux City
country: United States
facility: Velocity (Meridian) Clinical Research - Sioux City
state: Iowa
city: El Dorado
country: United States
facility: AMR - El Dorado - Heartland Research Associates
state: Kansas
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Newton
country: United States
facility: AMR - Newton (Heartland Research Associates)
state: Kansas
city: Wichita
country: United States
facility: AMR - Wichita West - Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: AMR - Wichita East - Heartland Research Associates
state: Kansas
city: Lexington
country: United States
facility: AMR - Lexington (Central Kentucky Research Associates)
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity (Meridian) Clinical Research - Baton Rouge
state: Louisiana
city: Covington
country: United States
facility: Avacare - Benchmark Research - New Orleans-North Shore
state: Louisiana
city: Covington
country: United States
facility: Velocity Clinical Research - MedPharmics - Covington
state: Louisiana
city: Gretna
country: United States
facility: Boca Raton Clinical Research (BRCR) Global USA - New Orleans
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research - MedPharmics - Lafayette
state: Louisiana
city: Metairie
country: United States
facility: Avacare - Benchmark Research - Metairie
state: Louisiana
city: New Orleans
country: United States
facility: AMR - New Orleans - Center for Clinical Research
state: Louisiana
city: Annapolis
country: United States
facility: Javara Research - Privia Medical Group Mid-Atlantic - Annapolis
state: Maryland
city: Baltimore
country: United States
facility: Pharmaron
state: Maryland
city: Rockville
country: United States
facility: Avacare (CCT) - Advanced Primary and Geriatric Care
state: Maryland
city: Rockville
country: United States
facility: Velocity (Meridian) Clinical Research - Rockville
state: Maryland
city: Mankato
country: United States
facility: Javara Research - Mankato Clinic
state: Minnesota
city: Gulfport
country: United States
facility: Velocity Clinical Research - MedPharmics - Gulfport
state: Mississippi
city: Kansas City
country: United States
facility: Avacare (CCT) - Clay Platte Family Medicine Clinic
state: Missouri
city: Elkhorn
country: United States
facility: Avacare (CCT) - Skyline Medical Center
state: Nebraska
city: Grand Island
country: United States
facility: Velocity (Meridian) Clinical Research - Grand Island
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies - Nebraska
state: Nebraska
city: Omaha
country: United States
facility: Velocity (Meridian) Clinical Research - Omaha
state: Nebraska
city: Portsmouth
country: United States
facility: hyperCORE - ActivMed Practices and Research - Portsmouth
state: New Hampshire
city: Jersey City
country: United States
facility: DM Clinical Research - Jersey City
state: New Jersey
city: Albuquerque
country: United States
facility: Velocity Clinical Research - Alburquerque
state: New Mexico
city: Santa Fe
country: United States
facility: AXCES Research & Health - Santa Fe
state: New Mexico
city: Albany
country: United States
facility: IMA Clinical Research - Albany, Suite 202
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research - Syracuse
state: New York
city: New York
country: United States
facility: IMA Clinical Research - Manhattan
state: New York
city: Rochester
country: United States
facility: Atlas Clinical Research - Rochester Clinical Research
state: New York
city: Cary
country: United States
facility: Cary Medical Group
state: North Carolina
city: Durham
country: United States
facility: Velocity Clinical Research - Durham
state: North Carolina
city: Hickory
country: United States
facility: Accellacare - Hickory
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare - Raleigh
state: North Carolina
city: Rocky Mount
country: United States
facility: Accellacare - Rocky Mount
state: North Carolina
city: Salisbury
country: United States
facility: Accellacare - Salisbury
state: North Carolina
city: Statesville
country: United States
facility: Accellacare - Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Tradd Court
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare - Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research - Cleveland (Rapid Medical Research)
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)
state: Ohio
city: Moore
country: United States
facility: Tekton Research - Oklahoma - Magnolia Court
state: Oklahoma
city: Tulsa
country: United States
facility: Tekton Research - Delaware Pointe
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research - Oklahoma - Primary Health Partners
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research - Grants Pass
state: Oregon
city: Hatboro
country: United States
facility: Avacare (CCT) - Hatboro Medical Associates
state: Pennsylvania
city: Media
country: United States
facility: Atlas Clinical Research - Suburban Research Associates - Media Office
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence (East Greenwich)
state: Rhode Island
city: Anderson
country: United States
facility: Velocity Clinical Research - Anderson
state: South Carolina
city: Charleston
country: United States
facility: Velocity Clinical Research - Charleston
state: South Carolina
city: Columbia
country: United States
facility: Velocity Clinical Research - Columbia (VitaLink)
state: South Carolina
city: Mount Pleasant
country: United States
facility: Accellacare - Charleston
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates - Myrtle Beach
state: South Carolina
city: North Charleston
country: United States
facility: hyperCORE International - Coastal Carolina Research Center
state: South Carolina
city: Union
country: United States
facility: Velocity Clinical Research - Union (Vitalink)
state: South Carolina
city: Bristol
country: United States
facility: Accellacare - PMG Research of Bristol
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research (AMR) - Corporate
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare of Knoxville
state: Tennessee
city: Abilene
country: United States
facility: Velocity Clinical Research - Abilene
state: Texas
city: Austin
country: United States
facility: IMA Clinical Research - Austin
state: Texas
city: Austin
country: United States
facility: Tekton Research - Austin
state: Texas
city: Austin
country: United States
facility: Orion Clinical Research
state: Texas
city: Austin
country: United States
facility: Velocity Clinical Research - Austin
state: Texas
city: Beaumont
country: United States
facility: Tekton Research - Beaumont
state: Texas
city: Brownsville
country: United States
facility: PanAmerican Clinical Research - Brownsville, Levee Street
state: Texas
city: Euless
country: United States
facility: Cedar Health Research - Arlington/Euless
state: Texas
city: Fort Worth
country: United States
facility: EmVenio Research - Fort Worth, TX
state: Texas
city: Fort Worth
country: United States
facility: Avacare - Benchmark Research Fort Worth
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - CyFair Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - Fredericksburg Road
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball - Multiple Specialties
state: Texas
city: Waco
country: United States
facility: Velocity Clinical Research - Waco (formerly: Impact Research Institute)
state: Texas
city: Roy
country: United States
facility: Avacare (CCT) - Ogden Clinic - Grand View
state: Utah
city: Salt Lake City
country: United States
facility: Avacare (CCT) - Olympus Family Medicine
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Norfolk
country: United States
facility: AMR - Norfolk (Clinical Research Associates of Tidewater)
state: Virginia
city: Suffolk
country: United States
facility: Centricity Research (IACT Health) - Suffolk Primary Care
state: Virginia
city: Spokane
country: United States
facility: Velocity Clinical Research - Medford
state: Washington
city: Spokane
country: United States
facility: Velocity Clinical Research - Spokane
state: Washington
Study officials:
affiliation: Vaxart, Inc.
name: James Cummings, MD
role: STUDY_DIRECTOR
References: