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

Status: Recruiting
Location: See all (145) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults 18 years of age and above, at time of screening.

• Completed primary approved/authorized COVID-19 vaccination series with ≥ 2 mRNA vaccine doses.

• Last COVID-19 vaccine received ≥6 months prior to study vaccination.

• Male and female participants of childbearing potential must agree to consistently use a highly effective method of contraception from at least 30 days prior to enrollment and through 3 months after the study vaccination.

• Male participants must refrain from sperm donation from the day of study vaccination through the end of the study. Female participants must refrain from egg donation at least 30 days prior to study vaccination through the end of the study.

• Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination) with screening lab values within normal limits or abnormalities assessed as not clinically significant. Screening platelet count must be \>140,000/μL.

• Agree to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, PrEP) during participation in the study.

• Willing and able to provide informed consent prior to initiation of study procedures.

• Available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.

⁃ Negative rapid molecular Covid test at the screening visit and on Day 1 prior to vaccine dosing.

Locations
United States
Alabama
Pinnacle Research Group
RECRUITING
Anniston
Core Clinical Trials - Central Alabama Research LLC
RECRUITING
Birmingham
Coastal Clinical Research
RECRUITING
Mobile
Arkansas
Baptist Health Center for Clinical Research - Little Rock
RECRUITING
Little Rock
Arizona
Avacare - Lenzmeier Family Medicine
RECRUITING
Glendale
Desert Clinical Research
RECRUITING
Mesa
Foothills Research Center
RECRUITING
Phoenix
Velocity Clinical Research - MedPharmics - Phoenix
RECRUITING
Phoenix
Avacare (CCT) - Fiel Family & Sports Medicine
RECRUITING
Tempe
California
Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group
RECRUITING
Cerritos
Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista)
RECRUITING
Chula Vista
Avacare - Benchmark Research - SOCAL-Colton
RECRUITING
Colton
Altasciences Los Angeles (Formerly WCCT Global)
RECRUITING
Cypress
Ark Clinical Research - Fountain Valley, CA
RECRUITING
Fountain Valley
Velocity Clinical Research - San Diego (eStudySite - La Mesa)
RECRUITING
La Mesa
Ark Clinical Research - Long Beach, CA
RECRUITING
Long Beach
Velocity Clinical Research (National Research Institute) - Panorama City
RECRUITING
Los Angeles
Avacare - Benchmark Research - Sacramento
RECRUITING
Sacramento
Northern California Research
RECRUITING
Sacramento
Velocity Clinical Research - Gardena
RECRUITING
Santa Ana
Colorado
Elite Research Network (ERN) - Legacy Clinical Trials
RECRUITING
Colorado Springs
Tekton Research - Fort Collins
RECRUITING
Fort Collins
Avacare - Critical Care, Pulmonary and Sleep Associates
RECRUITING
Lakewood
Tekton Research - Colorado - Longmont
RECRUITING
Longmont
Paradigm Clinical Research - Wheat Ridge
RECRUITING
Wheat Ridge
Connecticut
Stamford Therapeutics Consortium
RECRUITING
Stamford
Chase Medical Research
RECRUITING
Waterbury
Washington, D.c.
Velocity Clinical Research - Washington DC
RECRUITING
Washington D.c.
Florida
AMR - Miami (Clinical Research of South Florida)
RECRUITING
Coral Gables
Universal Axon Clinical Research
RECRUITING
Doral
Velocity Clinical Research - New Smyrna Beach
RECRUITING
Edgewater
Fleming Island Center For Clinical Research
RECRUITING
Fleming Island
AMR - Fort Myers - Clinical Physiology Associates
RECRUITING
Fort Myers
Velocity Clinical Research - Hallandale Beach (MD Clinical)
RECRUITING
Hallandale
ENCORE - Nature Coast Clinical Research Inverness
RECRUITING
Inverness
ENCORE - Westside Center for Clinical Research
RECRUITING
Jacksonville
Jacksonville Center for Clinical Research
RECRUITING
Jacksonville
Headlands Research - JEM Research - Lake Worth
RECRUITING
Lake Worth
Accel Research Sites - Lakeland
RECRUITING
Lakeland
Accel Research Sites (ARS) - St. Petersburg - Largo
RECRUITING
Largo
Accel Research Sites - Maitland
RECRUITING
Maitland
K2 Medical Research - Maitland
RECRUITING
Maitland
SRA Trials LLC - Miami Clinical Trials at Suncoast Research Associates
RECRUITING
Miami
Atlas Clinical Research - Suncoast Clinical Research - Pasco County
RECRUITING
New Port Richey
Biscayne Clinical Research
RECRUITING
North Miami Beach
K2 Medical Research - South Orlando
RECRUITING
Orlando
Boca Raton Clinical Research (BRCR) Global - Weston
RECRUITING
Plantation
ENCORE - St. Johns Center for Clinical Research
RECRUITING
Saint Augustine
IMA Clinical Research - St. Petersburg
RECRUITING
St. Petersburg
Georgia
hyperCORE - Centricity Research Columbus
RECRUITING
Columbus
Javara Research - Privia Medical Group Georgia
RECRUITING
Fayetteville
Privia Health - SouthCoast Health
RECRUITING
Fayetteville
Avacare (CCT) - Lifeline Primary Care
RECRUITING
Lilburn
hyperCORE - Centricity Research (IACT Health) - Rincon
RECRUITING
Rincon
Velocity Clinical Research - Savannah
RECRUITING
Savannah
Iowa
Accellacare - McFarland Clinic
RECRUITING
Ames
Velocity (Meridian) Clinical Research - Sioux City
RECRUITING
Sioux City
Idaho
Velocity Clinical Research - Boise (Meridian)
RECRUITING
Meridian
Illinois
IMA Clinical Research - Chicago
RECRUITING
Chicago
Accellacare - Duly Health and Care
RECRUITING
Lombard
Indiana
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
RECRUITING
Valparaiso
Kansas
AMR - El Dorado - Heartland Research Associates
RECRUITING
El Dorado
Johnson County Clin-Trials
RECRUITING
Lenexa
AMR - Newton (Heartland Research Associates)
RECRUITING
Newton
AMR - Wichita East - Heartland Research Associates
RECRUITING
Wichita
AMR - Wichita West - Heartland Research Associates
RECRUITING
Wichita
Kentucky
AMR - Lexington (Central Kentucky Research Associates)
RECRUITING
Lexington
Louisiana
Velocity (Meridian) Clinical Research - Baton Rouge
RECRUITING
Baton Rouge
Avacare - Benchmark Research - New Orleans-North Shore
RECRUITING
Covington
Velocity Clinical Research - MedPharmics - Covington
RECRUITING
Covington
Boca Raton Clinical Research (BRCR) Global USA - New Orleans
RECRUITING
Gretna
Velocity Clinical Research - MedPharmics - Lafayette
RECRUITING
Lafayette
Avacare - Benchmark Research - Metairie
RECRUITING
Metairie
AMR - New Orleans - Center for Clinical Research
RECRUITING
New Orleans
Maryland
Javara Research - Privia Medical Group Mid-Atlantic - Annapolis
RECRUITING
Annapolis
Pharmaron
RECRUITING
Baltimore
Avacare (CCT) - Advanced Primary and Geriatric Care
RECRUITING
Rockville
Velocity (Meridian) Clinical Research - Rockville
RECRUITING
Rockville
Minnesota
Javara Research - Mankato Clinic
RECRUITING
Mankato
Missouri
Avacare (CCT) - Clay Platte Family Medicine Clinic
RECRUITING
Kansas City
Mississippi
Velocity Clinical Research - MedPharmics - Gulfport
RECRUITING
Gulfport
North Carolina
Cary Medical Group
RECRUITING
Cary
Velocity Clinical Research - Durham
RECRUITING
Durham
Accellacare - Hickory
RECRUITING
Hickory
Accellacare - Raleigh
RECRUITING
Raleigh
Accellacare - Rocky Mount
RECRUITING
Rocky Mount
Accellacare - Salisbury
RECRUITING
Salisbury
Accellacare - Piedmont Healthcare
RECRUITING
Statesville
Accellacare - Tradd Court
RECRUITING
Wilmington
Accellacare - Winston-Salem
RECRUITING
Winston-salem
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
RECRUITING
Winston-salem
Nebraska
Avacare (CCT) - Skyline Medical Center
RECRUITING
Elkhorn
Velocity (Meridian) Clinical Research - Grand Island
RECRUITING
Grand Island
Be Well Clinical Studies - Nebraska
RECRUITING
Lincoln
Velocity (Meridian) Clinical Research - Omaha
RECRUITING
Omaha
New Hampshire
hyperCORE - ActivMed Practices and Research - Portsmouth
RECRUITING
Portsmouth
New Jersey
DM Clinical Research - Jersey City
RECRUITING
Jersey City
New Mexico
Velocity Clinical Research - Alburquerque
RECRUITING
Albuquerque
AXCES Research & Health - Santa Fe
RECRUITING
Santa Fe
New York
IMA Clinical Research - Albany, Suite 202
RECRUITING
Albany
Velocity Clinical Research - Syracuse
RECRUITING
East Syracuse
IMA Clinical Research - Manhattan
RECRUITING
New York
Atlas Clinical Research - Rochester Clinical Research
RECRUITING
Rochester
Ohio
Velocity Clinical Research - Cleveland (Rapid Medical Research)
RECRUITING
Beachwood
CTI Clinical Research Center
RECRUITING
Cincinnati
Velocity Clinical Research - Cincinnati (New Horizons Clinical Research - Blue Ash)
RECRUITING
Cincinnati
Oklahoma
Tekton Research - Oklahoma - Magnolia Court
RECRUITING
Moore
Tekton Research - Delaware Pointe
RECRUITING
Tulsa
Tekton Research - Oklahoma - Primary Health Partners
RECRUITING
Yukon
Oregon
Velocity Clinical Research - Grants Pass
RECRUITING
Grants Pass
Pennsylvania
Avacare (CCT) - Hatboro Medical Associates
RECRUITING
Hatboro
Atlas Clinical Research - Suburban Research Associates - Media Office
RECRUITING
Media
Rhode Island
Velocity Clinical Research - Providence (East Greenwich)
RECRUITING
East Greenwich
South Carolina
Velocity Clinical Research - Anderson
RECRUITING
Anderson
Velocity Clinical Research - Charleston
RECRUITING
Charleston
Velocity Clinical Research - Columbia (VitaLink)
RECRUITING
Columbia
Accellacare - Charleston
RECRUITING
Mt. Pleasant
Trial Management Associates - Myrtle Beach
RECRUITING
Myrtle Beach
hyperCORE International - Coastal Carolina Research Center
RECRUITING
North Charleston
Velocity Clinical Research - Union (Vitalink)
RECRUITING
Union
Tennessee
Accellacare - PMG Research of Bristol
RECRUITING
Bristol
Accellacare of Knoxville
RECRUITING
Knoxville
Alliance for Multispecialty Research (AMR) - Corporate
RECRUITING
Knoxville
Texas
Velocity Clinical Research - Abilene
RECRUITING
Abilene
IMA Clinical Research - Austin
RECRUITING
Austin
Orion Clinical Research
RECRUITING
Austin
Tekton Research - Austin
RECRUITING
Austin
Velocity Clinical Research - Austin
RECRUITING
Austin
Tekton Research - Beaumont
RECRUITING
Beaumont
PanAmerican Clinical Research - Brownsville, Levee Street
RECRUITING
Brownsville
Cedar Health Research - Arlington/Euless
RECRUITING
Euless
Avacare - Benchmark Research Fort Worth
RECRUITING
Fort Worth
EmVenio Research - Fort Worth, TX
RECRUITING
Fort Worth
DM Clinical Research - CyFair Clinical Research Center
RECRUITING
Houston
Tekton Research - Fredericksburg Road
RECRUITING
San Antonio
DM Clinical Research - Tomball - Multiple Specialties
RECRUITING
Tomball
Velocity Clinical Research - Waco (formerly: Impact Research Institute)
RECRUITING
Waco
Utah
Avacare (CCT) - Ogden Clinic - Grand View
RECRUITING
Roy
Avacare (CCT) - Olympus Family Medicine
RECRUITING
Salt Lake City
South Ogden Family Medicine
RECRUITING
South Ogden
Virginia
Health Research of Hampton Roads
RECRUITING
Newport News
AMR - Norfolk (Clinical Research Associates of Tidewater)
RECRUITING
Norfolk
Centricity Research (IACT Health) - Suffolk Primary Care
RECRUITING
Suffolk
Washington
Velocity Clinical Research - Medford
RECRUITING
Spokane
Velocity Clinical Research - Spokane
RECRUITING
Spokane
Contact Information
Primary
Maria Apkarian
ClinicalTrials@Vaxart.com
650-392-3109
Backup
Nick D'Amato
ClinicalTrials@Vaxart.com
650-392-3109
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2026-11
Participants
Target number of participants: 10400
Treatments
Experimental: VXA-CoV2-3.1 Safety Sentinel Cohort
Participants previously immunized against COVID-19 infection will be randomized to receive VXA-CoV2-3.1 (XBB.1.5 vaccine) tablet oral vaccine.
Active_comparator: COMIRNATY® Safety Sentinel Cohort
Participants previously immunized against COVID-19 infection will be randomized to receive COMIRNATY® (variant matched vaccine 2023-2024 formula) injectable COVID-19 vaccine.
Experimental: VXA-CoV2-3.3
If 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).
Active_comparator: COMIRNATY®
If 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.
Sponsors
Leads: Vaxart

This content was sourced from clinicaltrials.gov