Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model

Conditions
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Norovirus Infection

Intervention / Treatment
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* Biological: Norwalk GI.1 Virus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the research monitor and sponsor Available for all planned visits and to spend at least 5 days in confinement Confirmed blood type (A or O) Demonstrated to be H type-1 antigen secretor positive (by saliva test) Body mass index between 17 and 30 at screening Female subjects must have a negative pregnancy test and either use contraceptives or be sterile Available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly Exclusion Criteria: Presence of significant medical condition Donation or use of blood or blood products within 4 weeks prior to challenge Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic Abnormal stool pattern Any gastroenteritis within the past 2 weeks Occupational hazards, including having daily contact with children under the age of 5, women known to be pregnant, employment in the food service industry, health care workers, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Dose Inoculum<br>Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies | Biological: Norwalk GI.1 Virus<br>* Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.<br>|
| Experimental: Higher Dose Inoculum<br>Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies | Biological: Norwalk GI.1 Virus<br>* Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Norovirus Gastroenteritis (NVG) | Occurrence of NVG within 7 days post-challenge | 7 days post-challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Serious Adverse Events (SAEs) | Occurrence of SAEs | 42 ± 3 days post-challenge |