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NCT02816346 · ClinicalTrials.gov registry record · Phase 1
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
A Phase 1 study of Healthy, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT02816346: Completed Phase 1 study of Healthy, sponsored by PATH.
NCT02816346 is a Phase 1 study of Healthy that has completed, run by PATH. The registered enrollment target is 56 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02816346, a Phase 1 study of Healthy, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates. An adaptable dosing plan was used to determine the dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.
Primary Outcome
Per protocol definition: shedding of S. sonnei in the stool accompanied by moderate-severe diarrhea (4 or more loose/watery Grade 3-5 stools or 400+ gram stools per 24 hours, or requires medical intervention) and/or dysentery (a Grade 3, 4, or 5 stool with gross blood on at least 2 occasions and reportable constitutional symptoms) along with moderate fever (Oral temperature of ≥101.2°F) or one or more severe intestinal symptoms. Alternative endpoint 1 definition: severe diarrhea, or moderate di
Conditions Studied
Interventions
- BIOLOGICAL Shigella sonnei 53G
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2016-09-12 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 1 |
What the finished NCT02816346 record still lists
NCT02816346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Shigella sonnei 53G is the first listed.
NCT02816346 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02816346 about?
NCT02816346 is a clinical study titled "Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain". Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates. An adaptable dosing plan was used to determine the dose of Shigella sonnei 53G th...
What is the current status of trial NCT02816346?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2016-09-12. Estimated completion is 2017-12-31.
What conditions does trial NCT02816346 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02816346?
The interventions under investigation include: Shigella sonnei 53G (BIOLOGICAL).
Who is sponsoring clinical trial NCT02816346?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02816346 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02816346's enrollment target sits among peer trials
56 413th of 1090 higher than 665 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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