Norovirus InfectionsPhase 2NCT05626803
A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
A Phase 2 study testing Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose and Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose in people with Norovirus Infections, run by Vaxart at 3 sites in United States.
Trial summary
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. 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?
- Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose and Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jan 2023to 16 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- To be eligible for this study, subjects must meet all the following:
- In stable and good general health, without significant medical illness, based on medical history, physical examination, and vital signs at screening based on investigator judgement.
- Body mass index (BMI) between >/= 17.0 and </= 35.0 kg/m2 at screening SNG.
- Available for all planned visits and tele-health appointment, and willing to complete all protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
- Female subjects must not be breastfeeding and must provide a negative pregnancy test at screening and pre-dose.
- Female subjects must fulfill one of the following criteria:
Show all 10Show fewer
- At least 1 year post-menopausal (defined as amenorrhea for greater than or equal to 12 consecutive months prior to screening without alternative medical cause) or surgically sterile.
- Female subjects of childbearing potential must be willing to use a highly effective form of contraception for 30 days prior to initial vaccination and until 60 days after last vaccination. Acceptable forms are oral, implantable, intrauterine, transdermal, intravaginal, injectable, double barrier or abstinence (subjects using diaphragms must also use condom). The form of contraception must be approved by the investigator.
- Male subjects must agree to practice abstinence from heterosexual intercourse or to use an effective method of birth control as noted above from first vaccination to 60 days after last vaccination. Male subjects must agree to refrain from donating sperm and practice abstinence from all intercourse or to use an effective method of double barrier birth control or condom as noted above from first vaccination to 60 days after last vaccination.
- 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
- The subjects must be excluded from participating in the study if they meet any of the following:
- Known clotting/bleeding issues and/or personal and family history with increased risk of bleeding or clotting.
- 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
- 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:
Show all 34Show fewer
- Any history of: i. GI malignancy ii. malabsorption iii. pancreatobiliary disorders iv. inflammatory bowel disease v. irritable bowel disease vi. hiatal hernia vii. surgical resection b. History of diagnosis or treatment in past 5 years of: i. esophageal or gastric motility disorder ii. gastro esophageal reflux disorder iii. peptic ulcer iv. cholecystectomy
- History of any form of angioedema
- History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain
- Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
- Any condition that resulted in the absence or removal of the spleen
- Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical exam). (Assessment may be repeated once during Screening Period)
- Presence of a fever greater than or equal to 38°C measured orally at baseline.
- Any significant hospitalization within the last year which in the opinion of the investigator or sponsor could interfere with study participation.
- Any history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
- Family or personal history of bleeding or thrombosis.
- History of heparin-related thrombotic events, and/or receiving heparin treatments.
- History of autoimmune or inflammatory disease.
- 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 ii. Immobility (confined to bed or wheelchair for 3 or more successive days) iii. Head trauma with loss of consciousness or documented brain injury iv. Receipt of anticoagulants for prophylaxis of thrombosis v. Recent clinically significant infection, including hospitalization for COVID-19 infection.
- Any other condition that in the clinical judgement of the investigator would jeopardize the safety or rights of a subject taking the study drug, would render the subject unable to comply within the protocol or would interfere with the evaluation of the study endpoints diagnostic assessments.
- Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) tests at the screening visit.
- History of GI bleeding including hematochezia (blood in stool) or melena (black stool)
- Positive urine drug screen for drugs of abuse at screening (positive test for marijuana is not exclusionary; however concurrent use of marijuana during the study Active period through Day 29 is prohibited).
- Positive breath or urine alcohol test at screening and baseline.
- Receipt of a licensed vaccine (including any COVID-19 vaccines under emergency use authorization) within 14 days prior to baseline vaccination or planned administration during the study active period (Day 29).
- 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 (Day 29).
- Use of medications known to affect the immune function (e.g., including but not limited to systemic corticosteroids, leukotriene modifiers, and JAK inhibitors) within 2 weeks before study drug administration or planned use during the active study period (Day 29).
- Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the active study period (Day 29). Low dose daily ASA less than or equal to 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 NoV 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 (Day 29).
- History of drug, alcohol, or chemical abuse within 1 year of screening.
- History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin allergy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Ark Clinical Research
Long Beach, California, 90806
Nucleus Network Pty Ltd
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.
Read the detailed description
Norovirus infections are a leading cause of sporadic and epidemic gastroenteritis across all age groups worldwide. This study is designed as a standard double-blind placebo-controlled single administration, dose ranging study to evaluate the safety and immunogenicity of 2 different doses of VXA-GII.4-NS plus VXA-G1.1-NN (high and medium dose administered orally for the prevention of Norovirus infection), compared with a placebo.
This study will enroll a total of 135 subjects with10 sentinel subjects in an open label period (dosing staggered to not-more-than 2 subjects per 24 hours) and randomize 125 subjects in three arms.
The first 10 sentinel subjects will receive the open label high dose of active vaccine. If no dose-related toxicities are observed, and upon the recommendation of the SMC following review of safety data, subjects will be randomized in a 2:2:1 ratio to one of the 3 study arms to receive active vaccine or placebo. After vaccination on Day 1, the study will include an Active Study Period that runs through 4 weeks after administration (Day 29), and a Follow-up Period of one year for safety and duration of immune response.
- Conditions
- Norovirus Infections
- Being tested
- Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose, Placebo
- Medical subject headings
- Caliciviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/doseDrug
The first 10 sentinel subjects will receive open label high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose
Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/doseDrug
50 subjects will receive high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose
Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/doseDrug
50 subjects will receive Bivalent GII.4/GI.1 medium dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 5×10 to the power 10 tablets; total dose is 1×10 to the power 11 IU/dose
PlaceboDrug
25 subjects will receive matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Open Label Sentinel | Experimental | Bivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets total dose is 2×10 to the power 11 IU/dose (sentinel n=10) Receives: Drug: Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose |
| Medium Dose Arm | Experimental | Bivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 medium dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 5×10 to the power 10 tablets total dose is 1×10 to the power 11 IU/dose (N=50) Receives: Drug: Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose |
| High Dose Arm | Experimental | Bivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets total dose is 2×10 to the power 11 IU/dose (N=50) Receives: Drug: Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose |
| Placebo Arm | Placebo comparator | Placebo tablets (N= 25) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic)
Solicited adverse events (AEs) are predefined signs and symptoms of reactogenicity for which the participants were specifically questioned, and which were noted by the participant in their Solicited Symptom Diary for 7 days after drug administration, including:
- fever (any temperature 100.4°F or higher)
- headache
- myalgia (muscle pain)
- abdominal pain
- anorexia (defined as not eating)
- nausea
- vomiting
- diarrhoea
- malaise/fatigue.
The severity of each solicited symptoms of reactogenicity was graded by the participant as mild, moderate, severe or life-threatening. Participants with multiple Solicited AEs were only counted once in summarizing overall percentages of Solicited AEs, the highest severity of which was used.
Measured: Up to Day 8
Number of Participants With Unsolicited AEs
Treatment emergent AEs (TEAEs) are defined as AEs that occurred following the first administration of study medication. An unsolicited AE is an observed AE that did not fulfill the conditions prelisted in terms of diagnosis and/or onset window post-vaccination.
The severity of each AE was graded by the participant as mild, moderate or severe/ life-threatening.
Measured: Up to Day 29
Serum - Anti-Vaccine Protein 1 (VP1) GI.1 Immunoglobulin A (IgA) Levels by Meso Scale Discovery (MSD) Assay
Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and humoral immune (HI) function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Measured: Day 1 and Day 29
Fold Rise in Serum - Anti-VP1 GI.1 IgA Levels by MSD Assay
Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Measured: Day 1 and Day 29
Serum - Anti-VP1 GII.4 IgGA Levels by MSD Assay
Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Measured: Day 1 and Day 29
Fold Rise in Serum - Anti-VP1 GII.4 IgA Levels by MSD Assay
Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Measured: Day 1 and Day 29
Serum - Anti-VP1 GI.1 Immunoglobulin G (IgG) Levels by MSD Assay
Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Measured: Day 1 and Day 29
Fold Rise in Serum - Anti-VP1 GI.1 IgG Levels by MSD Assay
Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Measured: Day 1 and Day 29
Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Measured: Day 1 and Day 29
Fold Rise in Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Measured: Day 1 and Day 29
Serum - Anti-VP1 GI.1 Blocking Antibodies (BT50) Titers by MSD Assay
Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.
Measured: Day 1 and Day 29
Fold Rise in Serum - Anti-VP1 GI.1 BT50 Titers by MSD Assay
Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1).
Measured: Day 1 and Day 29
Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay
Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.
Measured: Day 1 and Day 29
Fold Rise in Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay
Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Measured: Day 1 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start26 Jan 2023
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Norovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Cummings, MD, Study director, Vaxart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626803
- Sponsor's protocol ID
- VXA-NVV-202
- Status last verified
- Apr 2025
- First submitted
- 15 Nov 2022
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.
- ClinicalTrials.gov ID
- NCT05626803
- Acronym / sponsor ID
- VXA-NVV-202
- Conditions
- Norovirus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.
Detailed description
Norovirus infections are a leading cause of sporadic and epidemic gastroenteritis across all age groups worldwide. This study is designed as a standard double-blind placebo-controlled single administration, dose ranging study to evaluate the safety and immunogenicity of 2 different doses of VXA-GII.4-NS plus VXA-G1.1-NN (high and medium dose administered orally for the prevention of Norovirus infection), compared with a placebo.
This study will enroll a total of 135 subjects with10 sentinel subjects in an open label period (dosing staggered to not-more-than 2 subjects per 24 hours) and randomize 125 subjects in three arms.
The first 10 sentinel subjects will receive the open label high dose of active vaccine. If no dose-related toxicities are observed, and upon the recommendation of the SMC following review of safety data, subjects will be randomized in a 2:2:1 ratio to one of the 3 study arms to receive active vaccine or placebo. After vaccination on Day 1, the study will include an Active Study Period that runs through 4 weeks after administration (Day 29), and a Follow-up Period of one year for safety and duration of immune response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open Label Sentinel | Experimental | Drug: Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/doseBivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets total dose is 2×10 to the power 11 IU/dose (sentinel n=10) |
| Medium Dose Arm | Experimental | Drug: Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/doseBivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 medium dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 5×10 to the power 10 tablets total dose is 1×10 to the power 11 IU/dose (N=50) |
| High Dose Arm | Experimental | Drug: Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/doseBivalent GII.4/GI.1 vaccine Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets total dose is 2×10 to the power 11 IU/dose (N=50) |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo tablets (N= 25) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- In stable and good general health, without significant medical illness, based on medical history, physical examination, and vital signs at screening based on investigator judgement.
- Body mass index (BMI) between >/= 17.0 and </= 35.0 kg/m2 at screening SNG.
- Available for all planned visits and tele-health appointment, and willing to complete all protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose).
- Female subjects must not be breastfeeding and must provide a negative pregnancy test at screening and pre-dose.
- Female subjects must fulfill one of the following criteria:
Key exclusion criteria (34 listed)
- The subjects must be excluded from participating in the study if they meet any of the following:
- Known clotting/bleeding issues and/or personal and family history with increased risk of bleeding or clotting.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/doseThe first 10 sentinel subjects will receive open label high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose | Drug | Open Label Sentinel |
| Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose50 subjects will receive high dose of active vaccine. Bivalent GII.4/GI.1 high dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 1×10 to the power 11 tablets; total dose is 2×10 to the power 11 IU/dose | Drug | High Dose Arm |
| Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose50 subjects will receive Bivalent GII.4/GI.1 medium dose vaccine (VXA-GII.4-NS plus VXA-G1.1-NN) 5×10 to the power 10 tablets; total dose is 1×10 to the power 11 IU/dose | Drug | Medium Dose Arm |
| Placebo25 subjects will receive matching placebo | Drug | Placebo Arm |
Primary outcome
Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic)
Time frame: Up to Day 8
Solicited adverse events (AEs) are predefined signs and symptoms of reactogenicity for which the participants were specifically questioned, and which were noted by the participant in their Solicited Symptom Diary for 7 days after drug administration, including: * fever (any temperature 100.4°F or higher) * headache * myalgia (muscle pain) * abdominal pain * anorexia (defined as not eating) * nausea * vomiting * diarrhoea * malaise/fatigue. The severity of each solicited symptoms of reactogenicity was graded by the participant as mild, moderate, severe or life-threatening. Participants with multiple Solicited AEs were only counted once in summarizing overall percentages of Solicited AEs, the highest severity of which was used.
Number of Participants With Unsolicited AEs
Time frame: Up to Day 29
Treatment emergent AEs (TEAEs) are defined as AEs that occurred following the first administration of study medication. An unsolicited AE is an observed AE that did not fulfill the conditions prelisted in terms of diagnosis and/or onset window post-vaccination. The severity of each AE was graded by the participant as mild, moderate or severe/ life-threatening.
Serum - Anti-Vaccine Protein 1 (VP1) GI.1 Immunoglobulin A (IgA) Levels by Meso Scale Discovery (MSD) Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and humoral immune (HI) function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Fold Rise in Serum - Anti-VP1 GI.1 IgA Levels by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GI.1 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Serum - Anti-VP1 GII.4 IgGA Levels by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Fold Rise in Serum - Anti-VP1 GII.4 IgA Levels by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GII.4 IgA were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Serum - Anti-VP1 GI.1 Immunoglobulin G (IgG) Levels by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Fold Rise in Serum - Anti-VP1 GI.1 IgG Levels by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GI.1 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method. Assay is measured in AU/mL.
Fold Rise in Serum - Anti-VP1 GII.4 IgG Levels by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GII.4 IgG were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Serum - Anti-VP1 GI.1 Blocking Antibodies (BT50) Titers by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.
Fold Rise in Serum - Anti-VP1 GI.1 BT50 Titers by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GI.1 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1).
Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. 95% confidence intervals were estimated by Clopper-Pearson exact method.
Fold Rise in Serum - Anti-VP1 GII.4 BT50 Titers by MSD Assay
Time frame: Day 1 and Day 29
Serum levels of Anti-VP1 GII.4 BT50 were evaluated using cellular and HI function assays from blood and mucosal (saliva and nasal swab) samples. The fold rise was calculated per participant by dividing the antibody concentration (original scale) on Day 29 with antibody concentration at baseline (Day 1). 95% confidence intervals were estimated by Clopper-Pearson exact method.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cummings, MD study director
Vaxart, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose and Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose in people with Norovirus Infections, run by Vaxart at 3 sites 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 10 inclusion and 34 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic) (time frame: Up to Day 8). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025.