Trial Outcomes & Findings for Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model (NCT NCT03721549)
NCT ID: NCT03721549
Last Updated: 2020-01-22
Results Overview
Occurrence of NVG within 7 days post-challenge
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
7 days post-challenge
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Baseline characteristics by cohort
| Measure |
Moderate Dose Inoculum
n=8 Participants
Moderate dose of Norwalk GI.1 Virus, 3.6x10\^5 genome copies
|
Higher Dose Inoculum
n=8 Participants
Higher dose of Norwalk GI.1 Virus, 1x10\^6 genome copies
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.50 years
STANDARD_DEVIATION 6.57 • n=5 Participants
|
39.88 years
STANDARD_DEVIATION 7.34 • n=7 Participants
|
36.19 years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Secretor Status
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days post-challengeOccurrence of NVG within 7 days post-challenge
Outcome measures
| Measure |
Moderate Dose Inoculum
n=8 Participants
Moderate dose of Norwalk GI.1 Virus, 3.6x10\^5 genome copies
|
Higher Dose Inoculum
n=8 Participants
Higher dose of Norwalk GI.1 Virus, 1x10\^6 genome copies
|
|---|---|---|
|
Frequency of Norovirus Gastroenteritis (NVG)
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 42 ± 3 days post-challengeOccurrence of SAEs
Outcome measures
| Measure |
Moderate Dose Inoculum
n=8 Participants
Moderate dose of Norwalk GI.1 Virus, 3.6x10\^5 genome copies
|
Higher Dose Inoculum
n=8 Participants
Higher dose of Norwalk GI.1 Virus, 1x10\^6 genome copies
|
|---|---|---|
|
Frequency of Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Moderate Dose Inoculum
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Higher Dose Inoculum
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moderate Dose Inoculum
n=8 participants at risk
Moderate dose of Norwalk GI.1 Virus, 3.6x10\^5 genome copies
|
Higher Dose Inoculum
n=8 participants at risk
Higher dose of Norwalk GI.1 Virus, 1x10\^6 genome copies
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
12.5%
1/8 • Day 45 ± 3
|
0.00%
0/8 • Day 45 ± 3
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Day 45 ± 3
|
12.5%
1/8 • Day 45 ± 3
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/8 • Day 45 ± 3
|
12.5%
1/8 • Day 45 ± 3
|
Additional Information
Erin Flynn, Associate Director of Regulatory Affairs
WCCT Global
Phone: 7207713080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place