Phase I Norovirus Challenge Model (NCT04174560) | Clinical Trial Compass
CompletedPhase 1
Phase I Norovirus Challenge Model
United States48 participantsStarted 2022-03-28
Plain-language summary
This is a safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to 48 healthy non-pregnant adults, 18-49 years of age, negative for COVID-19 by antigen testing at the time of norovirus challenge. Subjects will be admitted to the Vaccine Research Center inpatient facility and challenged with a dose of human norovirus GII.4 challenge strain. The challenge study will be conducted in 3 cohorts of approximately 16 subjects each, 15 subjects will have a functional FUT-2 gene (secretor positive) and 1 subject will have a non-functional FUT-2 gene (non-secretor). Subjects in Cohort 1 will receive 3.5x10\^3 copies of norovirus, in Cohort 2 will receive 3.5x10\^4 copies of norovirus and in Cohort 3 will receive 3.5x10\^5 copies of norovirus. Based on the illness rate of subjects meeting the primary outcome measure in secretor - positive subjects of the initial cohort, the decision will be made with regards to dosing of the second and the third cohorts. Study duration is approximately 12-18 months with subject participation duration of 6-8 months. The primary objective of this study is to determine the optimal challenge dose of Norovirus GII.4 CIN-3 Batch No.: 01-16C3 to achieve illness in \> / = 50% of subjects (illness is defined as norovirus infection determined by positive Polymerase Chain Reaction (PCR) and either: a) \> / = 3 loose or liquid stools, in a 24-hour period, b) \> / = 300 gm of loose or liquid stool in a 24-hour period or c) and/or any episode of vomiting), during the inpatient period.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion criteria
✓. Subject able to provide informed consent.
✓. Male or non-pregnant females between the ages of 18 and 49 years, inclusive.
✓. Women of childbearing potential must be using an acceptable method of birth control for at least 30 days prior to enrollment through day 45 after receipt of challenge virus.
✓. For women of childbearing potential, must have a negative serum or urine pregnancy test at screening.
✓. Are in good general health\*.
✓. Demonstrate knowledge and comprehension of the study by scoring \> / = 70% on a quiz (test of understanding) of the study protocol and policies.
✓. Willing and able to participate in all study visits, including an inpatient stay of at least 96 hours.
Exclusion criteria
✕. Have household contact with or have daily contact with children less than 2 years of age or persons older than 70 years of age.
✕
What they're measuring
1
The Occurrence of Norovirus-associated Illness in Secretor Positive Participants Through Day 4 After Challenge.
Timeframe: Day 1 through Day 4
Trial details
NCT IDNCT04174560
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Have expected extended social contact (\> 2 hours/day) with immunocompromised individuals in the 8 weeks after challenge\*.
✕. Are healthcare workers with direct patient contact or any child day care services (in-home or non-residential facility) in the 8 weeks after challenge.
✕. Are positive for COVID-19 by an antigen test at the time of admission to the challenge unit.
✕. Are food service workers expected to prepare/handle food in the 8 weeks after challenge.
✕. Plan to be living in a confined communal environment (e.g. ship, camp, or dormitory) within 8 weeks after receiving the challenge strain.
✕. For females, are pregnant or plan to become pregnant at any time between the Screening Visit through 45 days after receipt of the challenge virus.
✕. Are breastfeeding or plan to breastfeed at any given time throughout the study.