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

Running, not enrolling · Phase 2

Conditions studied: SARS-CoV2, COVID-19

In brief

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.

Key facts

Study ID

NCT06672055

Run by

Vaxart

People needed

5485

Starts

2024-10-08

Expected to finish

2027-05-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• Participant has an acute illness as defined by any of the following (note: assessment may be repeated once during screening period) as determined by the site investigator, within 72 hours prior to vaccination:
• An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol.
• Presence of a fever ≥ 38.0°C (100.4°F) measured orally at baseline, on Day 1 prior to vaccination.
• Receipt of antipyretic/analgesic medications within 24 hours prior to vaccine administration.
• Participant has had a positive COVID test within 90 days prior to screening.
• Current or planned participation in any other interventional clinical trial.
• Participation in research involving any investigational product within 45 days prior to study vaccination.
• Receipt of any approved or authorized products intended to prevent SARS-CoV2 infection within 6 months prior to study vaccination.
• Receipt or donation of blood products or immunoglobulins within 60 days prior to enrollment or planned administration during the study.
• Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination.
• Any autoimmune or immunodeficiency disease/condition (including and not limited to untreated or advanced HIV infection with CD4 counts <200 cells/mm\^3, history of AIDS defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV, severe combined immunodeficiency (SCID), hypogammaglobulinemia, asplenia or functional asplenia). 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:

Where it is running

• Core Clinical Trials - Central Alabama Research LLC — Birmingham, Alabama, United States
• Coastal Clinical Research — Mobile, Alabama, United States
• Avacare - Lenzmeier Family Medicine — Glendale, Arizona, United States
• Desert Clinical Research — Mesa, Arizona, United States
• Velocity Clinical Research - MedPharmics - Phoenix — Phoenix, Arizona, United States
• Foothills Research Center — Phoenix, Arizona, United States
• Avacare (CCT) - Fiel Family & Sports Medicine — Tempe, Arizona, United States
• Baptist Health Center for Clinical Research - Little Rock — Little Rock, Arkansas, United States
• Elligo Health Research (BTC/ClinEdge) - Core Healthcare Group — Cerritos, California, United States
• Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista) — Chula Vista, California, United States
• Avacare - Benchmark Research - SOCAL-Colton — Colton, California, United States
• Altasciences Los Angeles (Formerly WCCT Global) — Cypress, California, United States
• Ark Clinical Research - Fountain Valley, CA — Fountain Valley, California, United States
• Velocity Clinical Research - San Diego (eStudySite - La Mesa) — La Mesa, California, United States
• Ark Clinical Research - Long Beach, CA — Long Beach, California, United States
• Velocity Clinical Research (National Research Institute) - Panorama City — Los Angeles, California, United States
• Northern California Research — Sacramento, California, United States
• Avacare - Benchmark Research - Sacramento — Sacramento, California, United States
• Velocity Clinical Research - Gardena — Santa Ana, California, United States
• Elite Research Network (ERN) - Legacy Clinical Trials — Colorado Springs, Colorado, United States
• Tekton Research - Fort Collins — Fort Collins, Colorado, United States
• Avacare - Critical Care, Pulmonary and Sleep Associates — Lakewood, Colorado, United States
• Tekton Research - Colorado - Longmont — Longmont, Colorado, United States
• Paradigm Clinical Research - Wheat Ridge — Wheat Ridge, Colorado, United States
• Pinnacle Research Group — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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