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| Name | Class |
|---|---|
| Vaxart | INDUSTRY |
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There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Dose Inoculum | Experimental | Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies |
|
| Higher Dose Inoculum | Experimental | Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norwalk GI.1 Virus | Biological | Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Norovirus Gastroenteritis (NVG) | Occurrence of NVG within 7 days post-challenge | 7 days post-challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Serious Adverse Events (SAEs) | Occurrence of SAEs | 42 ± 3 days post-challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global | Costa Mesa | California | 92626 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Dose Inoculum | Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies Norwalk GI.1 Virus: Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu. |
| FG001 | Higher Dose Inoculum | Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies Norwalk GI.1 Virus: Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Dose Inoculum | Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies |
| BG001 | Higher Dose Inoculum | Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Norovirus Gastroenteritis (NVG) | Occurrence of NVG within 7 days post-challenge | Posted | Count of Participants | Participants | 7 days post-challenge |
|
|
Day 45 ± 3
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Dose Inoculum | Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Flynn, Associate Director of Regulatory Affairs | WCCT Global | 7207713080 | erin.flynn@wcct.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2018 | Jan 9, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2019 | Jan 9, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017250 | Caliciviridae Infections |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Secretor Status | H type-1 antigen secretor positive | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Frequency of Serious Adverse Events (SAEs) | Occurrence of SAEs | Posted | Count of Participants | Participants | 42 ± 3 days post-challenge |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Higher Dose Inoculum | Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies | 0 | 8 | 0 | 8 | 2 | 8 |
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
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