Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies (NCT02473224) | Clinical Trial Compass
CompletedPhase 1
Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies
United States44 participantsStarted 2015-10-28
Plain-language summary
This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype 2 (GII.2) isolate designated Snow Mountain virus (SMV). The study duration is 24 - 36 months. The primary objectives are to: 1) evaluate the safety and reactogenicity of the GII.2 Snow Mountain norovirus challenge stock and 2) determine a safe and optimal challenge dose of GII.2 Snow Mountain norovirus to achieve illness in a high proportion (= / \> 75%) of subjects.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject able to provide written informed consent
. Male or non-pregnant females between the ages of 18 and 49 years, inclusive
. Women of childbearing potential must be practicing abstinence or using an acceptable method of birth control for at least 30 days prior to enrollment through day 45 after receipt of the challenge virus. Male subjects must agree not to father a child prior to day 45 after receipt of the challenge virus
. For women of childbearing potential, must have a negative serum or urine pregnancy test at screening and negative urine pregnancy test within 24 hours prior to challenge
. Are in good general health, as determined by the study investigator within 60 days of challenge
. Demonstrate knowledge and comprehension of the study by scoring \>/= 70 percent on a quiz of the study protocol and policies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infectious Dose-50 based on infection rate after challenge with various doses
Timeframe: Day 2 to Day 5
2
Number of serious adverse events related to virus challenge
Timeframe: Day 1 to Day 180
3
Number of subjects experiencing any mild reactogenicity outcomes
Timeframe: Day 1 to Day 10
4
Number of subjects experiencing any moderate reactogenicity outcomes
Timeframe: Day 1 to Day 10
5
Number of subjects experiencing any severe reactogenicity outcomes
Timeframe: Day 1 to Day 10
6
Number of subjects experiencing Grade 3 adverse events
Timeframe: Day 1 to Day 30
7
Proportion of subjects with GII.2 Snow Mountain norovirus-associated illness following GII.2 challenge
Timeframe: Day 1 to Day 5
Trial details
NCT IDNCT02473224
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Willing and able to participate in all study visits, including an inpatient stay of at least 96 hours
. Demonstrated to be H type I secretor positive for HBGA binding by assay of saliva (this applies to all cohorts except the SN cohort, which will include secretor negative subjects only)
Exclusion criteria
. Have household contact with or have daily contact with children under 2 years of age or persons older than 70 years of age
. Have expected occupational or social contact with immunocompromised individuals in the 8 weeks after challenge, including persons with HIV infection or active cancer, children \<2 years of age, pregnant women or persons who are immunosuppressed (e.g. history of stem cell or organ transplantation). Individuals who provide any child day care services (in-home or non-residential facility) are also excluded
. Are healthcare workers with patient contact in the 8 weeks after challenge
. Are food service workers expected to prepare/handle food in the 8 weeks after challenge
. Plan to be living in a confined 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
. Have a history of gastroenteritis in the 4 weeks prior to challenge or any history of chronic or recurrent diarrhea or vomiting