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Norovirus InfectionsPhase 1NCT06944717

A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

A Phase 1 study testing VXA-G1.1-NN, VXA-G2.4-NS and VXA G1.1 NN-T in people with Norovirus Infections, run by Vaxart at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Norovirus Infections
What is being tested?
VXA-G1.1-NN, VXA-G2.4-NS and VXA G1.1 NN-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
3 Mar 2025to 14 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥ 18 and ≤ 80 years old at the time of signing the Informed Consent Form (ICF).
  • In stable and good general health and without significant medical illness (based on review of medical history, physical examination, current health status, and vital signs at Screening) as determined by the Investigator, with Screening lab values within normal limits or abnormalities assessed as not clinically significant.
  • Body mass index (BMI) > 17.0 and < 35.0 kg/m^2 at Screening.
  • Available for all planned visits and tele-health appointments, and willing to complete all Protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
  • Male or female participants.
  • Female participants must not be breastfeeding and must provide a negative pregnancy test at Screening and pre-dose on Day 0.
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  • Female participants must fulfill at least one of the following criteria:
  • At least 1 year post-menopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without alternative medical cause) or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation).
  • Female participants of childbearing potential must be willing to use a highly effective form of contraception for 30 days prior to study drug administration and until 60 days after study drug administration. Acceptable forms are oral, implantable, intrauterine, transdermal, intravaginal, injectable, double barrier or abstinence (participants using diaphragms must also use condoms). The Investigator must approve the form of contraception. Female participants must also refrain from egg donation for the 1 month prior to dosing through 60 days post-vaccination.
  • Male participants must fulfill one of the following criteria:
  • Male participants must agree to refrain from donating sperm and practice abstinence from all intercourse or use an effective method of birth control which includes condom use from study drug administration to 90 days post-dose.
  • At least 1 year post-vasectomy and have confirmed that they have obtained documentation of the absence of sperm in the ejaculate.
  • Capable of understanding and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the Protocol.

Who cannot join

  • Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months prior to Screening and reconfirmed at baseline.
  • Cancer, or treatment for cancer or any procedure or preventive medication for cancer or to prevent recurrence, within past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma).
  • Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus- type 1 and 2, asplenia, and functional asplenia.
  • 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:
  • Gastrointestinal malignancy
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  • Masabsorption
  • Pancreato-biliary disorders
  • Inflammatory bowel disease
  • Irritable bowel disease
  • Hiatal hernia
  • Surgical resection
  • History of diagnosis or treatment in past 5 years of:
  • Osophageal or gastric motility disorder
  • Gastro esophageal 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.
  • The participants has ongoing / unresolved post-cholecystectomy digestive symptoms within 30 days prior to dosing.
  • History of any form of angioedema.
  • History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
  • Known contraindication to blood draws (e.g., bleeding diathesis, acquired coagulopathy, significant bleeding, or bruising) or to oral route of administration (unable to swallow tablets).
  • Has an acute disease within 72 hours prior to study drug administration, defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam), including the following (Note: Assessment may be repeated once during Screening Period):
  • 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 dosing.
  • Receipt of antipyretic/analgesic medications within 24 hours prior to vaccine administration.
  • Any significant hospitalization within the last year which in the opinion of the Investigator or Sponsor could interfere with study participation.
  • Any of the following personal and/or family history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
  • Familial coagulopathy or hypercoagulability or personal history of bleeding disorder or thrombosis/embolus.
  • History of heparin-related thrombotic events, and/or receiving heparin treatments.
  • History of autoimmune or inflammatory disease such as autoimmune thyroiditis, vitiligo, rheumatoid arthritis.
  • Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to Screening:
  • Recent surgery other than removal/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 Coronavirus Disease 19 (COVID-19) related illness.
  • Any other condition that in the clinical judgement of the investigator would jeopardize the safety or rights of a participant taking the study drug, would render the participant unable to comply within the Protocol or would interfere with the evaluation of the study endpoints diagnostic assessments including a history of drug, alcohol, or chemical abuse within 1 year of Screening.
  • Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) tests at the Screening visit.
  • History of gastrointestinal bleeding including hematochezia (blood in stool) or melena (black stool) of unknown etiology or that has not been evaluated.
  • Positive urine drug screen (UDS) for drugs of abuse at Screening (positive test for marijuana is not exclusionary; however concurrent use of marijuana during the Active Study Period through Day 28 is prohibited). Positive UDS at Screening due to prescribed stimulants will be reviewed on a case by case basis.
  • Positive breath or urine alcohol test at baseline (prior to dosing).
  • Receipt of a licensed vaccine (including any COVID-19 vaccines under Emergency Use Authorization [EUA]) within 14 days prior to study drug administration or planned administration during the Active Study Period (Day 28).
  • Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 7 days prior to study drug administration or planned use during the active study period (up to Day 28).
  • Use of drugs known to affect gastrointestinal motility including glucagon-like peptide 1 receptor agonists including tirzepatide (Mounjaro) and semaglutide (Wegovy, Ozempic) within 30 days prior to drug administration or planned use through Day 7. Okay to restart after Day 7 if with full resolution of solicited symptoms of reactogenicity.
  • Use of medications known to affect the immune function (e.g., including but not limited to corticosteroids (systemic, intranasal, inhaled, or intra-articular), leukotriene modifiers, and Janus kinase inhibitors) within 14 days before study drug administration or planned use during the Active Study Period (up to Day 28).
  • Exception to the timeframe: 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 Principal Investigator must document the treating allergist's approval.
  • Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the active study period (up to Day 28). Low daily doses of acetylsalicylic acid ≤ 100 mg for cardio-protection is not exclusionary.
  • Administration of any investigational vaccine, drug or device within 8 weeks preceding study drug administration, or planned use within the duration of the study.
  • Previous participation in a Vaxart Clinical Trial or other norovirus vaccine trial unless confirmed receipt of placebo.
  • Donation or use of blood or blood products within 30 days prior to study drug administration or planned donation during the active study period (up to Day 28).
  • History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to, fish gelatin allergy.
  • 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

1 site in 1 country.

United States1 site

  • Johnson County Clin Trials - JCCT

    Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: A Phase 1, Single Center, Open Label, Single Dose, Dose Escalation Study to Determine the Safety and Immunogenicity of a Novel Bivalent Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Volunteers Aged ≥ 18 Years and ≤ 80 Years Old

The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.

Being tested
VXA-G1.1-NN, VXA-G2.4-NS, VXA G1.1 NN-T, VXA G2.4 NS-T
Keywords
Norovirus, Healthy participants, VXA-G1.1-NN, VXA-G2.4-NS, VXA-G2.4-NS-T, VXA-G1.1-NN-T
Medical subject headings
Caliciviridae Infections

What participants receive

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

  • VXA-G1.1-NNBiological

    Legacy vaccine, administered orally.

  • VXA-G2.4-NSBiological

    Legacy vaccine, administered orally.

  • VXA G1.1 NN-TBiological

    Next generation vaccine, administered orally.

  • VXA G2.4 NS-TBiological

    Next generation vaccine, administered orally.

Study groups in NCT06944717
Study groupRoleWhat they receive
Bivalent Low Dose Next Generation VaccineExperimentalHealthy participants will receive Norovirus GI.1 Norwalk VP1 Vaccine, Modified Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G1.1-NN-T) (1x10^10 infectious units (IU)) and Norovirus GII.4 Sydney VP1 Vaccine, Modified Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G2.4-NS-T) (1x10^10 IU) orally.
Receives: Biological: VXA G1.1 NN-T; Biological: VXA G2.4 NS-T
Bivalent High Dose Legacy VaccineExperimentalHealthy participants will receive Norovirus GI.1 Norwalk Vaccine Protein 1 (VP1) Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded ribonucleic acid (dsRNA) Adjuvant (VXA-G1.1-NN) (1x10^11 IU) and Norovirus GII.4 Sydney VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant (VXA-G2.4-NS) (1x10^11 IU) orally.
Receives: Biological: VXA-G1.1-NN; Biological: VXA-G2.4-NS
Bivalent High Dose Next Generation VaccineExperimentalHealthy participants will receive VXA-G1.1-NN-T (1x10^11 IU) and VXA-G2.4-NS-T (1x10^11 IU) orally. A sentinel group will be enrolled, if there is positive recommendation from the safety monitoring committee, enrollment will continue in this arm.
Receives: Biological: VXA G1.1 NN-T; Biological: VXA G2.4 NS-T

What is being measured

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

  1. Number of Participants Experiencing Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

    Measured: 7 days

  2. Duration of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

    Measured: Approximately 1 year

  3. Severity of Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose

    Measured: 7 days

  4. Number of Participants Experiencing Unsolicited Adverse Events (AE) for 28 Days Following the Study Intervention Dose

    Measured: 28 days

  5. Number of Participants Experiencing Unsolicited New Onset of Chronic Illness (NOCI) for 28 Days Following the Study Intervention Dose

    Measured: 28 days

  6. Duration of Unsolicited AEs for 28 Days Following the Study Intervention Dose

    Measured: Approximately 1 year

  7. Duration of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose

    Measured: Approximately 1 year

  8. Severity of Unsolicited AEs for 28 Days Following the Study Intervention Dose

    Measured: 28 days

  9. Severity of Unsolicited NOCIs for 28 Days Following the Study Intervention Dose

    Measured: 28 days

  10. Geometric Mean Titer (GMT) at Day 0 of Serum Functional Antibody Against GI.1 Measured by Norovirus Blocking Antibody Assay (NBAA)

    Measured: Day 0

  11. GMT at Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA

    Measured: Day 28

  12. GMT at Day 0 of Serum Functional Antibody Against GII.4 Measured by NBAA

    Measured: Day 0

  13. GMT at Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA

    Measured: Day 28

  14. Geometric Mean Fold Rise (GMFR) from Day 0 to Day 28 of Serum Functional Antibody Against GI.1 Measured by NBAA

    Measured: From Day 0 to Day 28

  15. GMFR from Day 0 to Day 28 of Serum Functional Antibody Against GII.4 Measured by NBAA

    Measured: From Day 0 to Day 28

Timeline

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

  1. First posted25 Apr 2025
  2. Study start3 Mar 2025
  3. Primary completion14 Apr 2026
  4. Study completion14 Apr 2026

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 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944717
Sponsor's protocol ID
VXA-NVV-109
Status last verified
Jul 2026
First submitted
17 Apr 2025
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VXA-G1.1-NN, VXA-G2.4-NS and VXA G1.1 NN-T in people with Norovirus Infections, run by Vaxart at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 61 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Solicited Symptoms of Reactogenicity (Gastrointestinal and Systemic) for 1 Week Following Study Intervention Dose (time frame: 7 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06944717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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