Trials Sponsors Conditions Drugs Pricing

Conditions

Norovirus Infections

Outcome Measures

Primary Outcomes (14)

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
Day 1 and Day 29

Study Arms (4)

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)

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)

Drug: Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose

High Dose Arm

EXPERIMENTAL

Interventions

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

Open Label Sentinel

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

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

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

You may qualify if:

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.

Sponsors & Collaborators

Vaxart
Industrylead

Study Sites (3)

Ark Clinical Research

Long Beach, California, 90806, United States

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Nucleus Network Pty Ltd

Saint Paul, Minnesota, 55114, United States

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Results Point of Contact

Title: Melanie Drayton
Organization: Vaxart

Study Officials

James Cummings, MD
Vaxart, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

135 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 25, 2022

Study Start

January 26, 2023

Actual (reported)

You may not qualify if:

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:
a. 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:
+17 more criteria

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (14)

Study Arms (4)

Open Label Sentinel

Medium Dose Arm

High Dose Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo Arm

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (14)

Study Arms (4)

Open Label Sentinel

Medium Dose Arm

High Dose Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Placebo Arm

You may not qualify if:

Data Sharing

Source record

Documents

Locations