Norovirus Infection
Conditions
Brief summary
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.
Interventions
BIOLOGICALNorwalk GI.1 Virus
Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
Sponsors
Vaxart
WCCT Global
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Norovirus Gastroenteritis (NVG) | 7 days post-challenge | Occurrence of NVG within 7 days post-challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Serious Adverse Events (SAEs) | 42 ± 3 days post-challenge | Occurrence of SAEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate Dose Inoculum Moderate dose of Norwalk GI.1 Virus, 3.6x10\^5 genome copies | 8 |
| Higher Dose Inoculum Higher dose of Norwalk GI.1 Virus, 1x10\^6 genome copies | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Moderate Dose Inoculum | Higher Dose Inoculum | Total |
|---|---|---|---|
| Age, Continuous | 32.50 years STANDARD_DEVIATION 6.57 | 39.88 years STANDARD_DEVIATION 7.34 | 36.19 years STANDARD_DEVIATION 7.73 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Region of Enrollment United States | 8 Participants | 8 Participants | 16 Participants |
| Secretor Status | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Frequency of Norovirus Gastroenteritis (NVG)
Occurrence of NVG within 7 days post-challenge
Time frame: 7 days post-challenge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate Dose Inoculum | Frequency of Norovirus Gastroenteritis (NVG) | 5 Participants |
| Higher Dose Inoculum | Frequency of Norovirus Gastroenteritis (NVG) | 4 Participants |
Secondary
Frequency of Serious Adverse Events (SAEs)
Occurrence of SAEs
Time frame: 42 ± 3 days post-challenge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate Dose Inoculum | Frequency of Serious Adverse Events (SAEs) | 0 Participants |
| Higher Dose Inoculum | Frequency of Serious Adverse Events (SAEs) | 0 Participants |