Trials Sponsors Conditions Drugs Pricing

Conditions

Norovirus Infections

Keywords

Healthy participantsVXA-G1.1-NNVXA-G2.4-NS

Outcome Measures

Primary Outcomes (18)

Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose
Solicited symptoms of reactogenicity were predefined adverse events (AEs) for which the participant was specifically questioned, and which were noted by the participant in their solicited symptom diary, including: fever (any temperature 100°F or higher), headache, myalgia (muscle pain), abdominal pain, anorexia (defined as not eating), nausea, vomiting, diarrhea, and malaise/fatigue. The severity of each solicited symptom of reactogenicity was graded by the participant as mild, moderate, severe or life-threatening.
1 week post study dose (8 days)
Number of Participants (Mothers) With Unsolicited Treatment-emergent Adverse Events (TEAEs)
TEAEs:AEs that began after start of an investigational product or an already present event that worsens in intensity or frequency following intervention.An AE considered serious (SAE) if,in view of Investigator or Sponsor,it resulted in death,life-threatening AE,inpatient hospitalization/prolongation of hospitalization,persistent or significant incapacity or disability disrupting normal life functions,congenital anomaly/birth defect,or an important medical event which based upon medical judgment may have jeopardized participant and required intervention to prevent 1 of outcomes.AESIs:serious/non-serious AEs of scientific and medical concern with potential immune mediated conditions and events associated with thrombosis and thrombocytopenia.NOCI:diagnosis post-enrollment and vaccination of new chronic medical condition,including those controllable by medication.An AE was unsolicited if it did not fulfill conditions prelisted in eCRF in terms of diagnosis/onset window post-vaccination.
4 weeks post dose (29 days)
Geometric Mean Concentration (GMC) of Serum Viral Protein 1 (VP1) Specific (G1.1) Immunoglobulin A (IgA) on Days 1, 8 and 29
GMC of serum VP1 specific (G1.1) IgA was measured by Meso Scale Discovery (MSD) assay. Assay was measured in an arbitrary unit per milliliter (AU/mL).

Secondary Outcomes (23)

Number of Participants With SAEs, AESIs and NOCIs Through 12 Months Post Dose
Up to 12 months
GMC of Serum VP1 Specific (G1.1) IgA on Day 180
Day 180
GMC of Serum VP1 Specific (G2.4) IgA on Day 180
Day 180
GMFR of Serum VP1 Specific (G1.1) IgA From Day 1 to Day 180
Day 1 to Day 180
GMFR of Serum VP1 Specific (G2.4) IgA From Day 1 to Day 180
Day 1 to Day 180
+18 more secondary outcomes

Other Outcomes (19)

GMC of Nasal VP1 Specific (G1.1) IgA
Days 1, 8, 29, 60, and 180
GMC of Nasal VP1 Specific (G2.4) IgA
Days 1, 8, 29, 60, and 180
GMFR of Nasal VP1 Specific (GI.I) IgA From Day 1 to Days 8, 29, 60 and 180
Day 1 to Days 8, 29, 60 and 180
+16 more other outcomes

Study Arms (3)

Bivalent GII.4/GI.1 Medium Dose Vaccine

EXPERIMENTAL

Participants will receive a medium dose of bivalent VXA-G1.1-NN and VXA-GII.4-NS as an oral tablet on Day 1.

Biological: VXA-G1.1-NNBiological: VXA-G2.4-NS

Bivalent GII.4/GI.1 High Dose Vaccine

EXPERIMENTAL

Participants will receive a high dose of bivalent VXA-G1.1-NN and VXA-GII.4-NS as an oral tablet on Day 1.

Biological: VXA-G1.1-NNBiological: VXA-G2.4-NS

Placebo

PLACEBO COMPARATOR

Interventions

VXA-G1.1-NNBiological

Oral tablets.

Also known as: GI.1

Bivalent GII.4/GI.1 High Dose VaccineBivalent GII.4/GI.1 Medium Dose Vaccine

VXA-G2.4-NSBiological

Oral tablets.

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Lactating females aged ≥ 18 years at the time of enrolment and their breastfed infants aged \>30 days to 11 months of age at the time of the participants' study drug administration.
In stable and good general health, without significant medical illness, based on medical history, physical examination (including vital signs), and clinical judgment of the investigator.

Sponsors & Collaborators

Vaxart
Industrylead

Study Sites (5)

WITS RHI Research Centre

Hillbrow, 2001, South Africa

Progress Clinical Research Unit

Honeydew, 2040, South Africa

Newtown Clinical Research Centre

Johannesburg, 2001, South Africa

Trident Clinical

Kimberley, 8301, South Africa

FCRN Clinical Trials Centre (Pty) Ltd

Vereeniging, 1935, South Africa

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Results Point of Contact

Title: Maria Apkarian
Organization: Vaxart

Study Officials

Medical Director
Vaxart, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

76 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

October 27, 2023

Actual (reported)

You may not qualify if:

Presence of a fever ≥ 38.0°C measured orally at baseline, on Day 1 prior to vaccination. (Assessment may be repeated once during screening period).
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).
Participants who have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) tests at the screening visit.
History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin.
History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including the institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline.
History of significant pregnancy-related complications during this pregnancy, including but not limited to pre-eclampsia, eclampsia, or gestational diabetes unless a full resolution is documented.
Cancer, or treatment for cancer, within the 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 or 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:
a. Any history of:
i. Malignancy
ii. Malabsorption
iii. Pancreatobiliary disorders
+35 more criteria

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (18)

Secondary Outcomes (23)

Other Outcomes (19)

Study Arms (3)

Bivalent GII.4/GI.1 Medium Dose Vaccine

Bivalent GII.4/GI.1 High Dose Vaccine

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (18)

Secondary Outcomes (23)

Other Outcomes (19)

Study Arms (3)

Bivalent GII.4/GI.1 Medium Dose Vaccine

Bivalent GII.4/GI.1 High Dose Vaccine

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations