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NCT04992520 · ClinicalTrials.gov registry record · Phase 1
Controlled Human Infection Model Challenge/Rechallenge
A Phase 1 study, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT04992520: Completed Phase 1 study, sponsored by PATH.
NCT04992520 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04992520, a Phase 1 study, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
The goal of this study is to better understand Shigella immunity. The study will compare the shigellosis rate in participants previously challenged with a different Shigella serotype to the attack rate in participants not previously exposed to Shigella (naive participants).
Primary Outcome
Shigellosis was defined as: * Severe diarrhea: ≥ 6 loose (grade 3-5) stools within 24 hours or \>800 - 999 g loose stools within any 24-hour window, or * Moderate diarrhea (4 - 5 loose stools within 24 hours or 401-800 g loose stools within any 24-hour window) with fever (oral temperature of ≥ 101.2°F / 38°C) OR with ≥ 1 moderate constitutional or enteric symptom OR ≥ 2 episodes of vomiting in a 24-hour period, or * Dysentery: ≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours A
Interventions
- BIOLOGICAL Shigella sonnei 53G
- BIOLOGICAL Shigella flexneri 2a 2457T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-04-26 |
| Est. Completion | 2023-08-29 |
| Phase | Phase 1 |
What the finished NCT04992520 record still lists
NCT04992520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Shigella sonnei 53G is the first listed.
NCT04992520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04992520 about?
NCT04992520 is a clinical study titled "Controlled Human Infection Model Challenge/Rechallenge". The goal of this study is to better understand Shigella immunity. The study will compare the shigellosis rate in participants previously challenged with a different Shigella serotype to the attack rate in participants not previously exposed to Shigella (naive participants).
What is the current status of trial NCT04992520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2022-04-26. Estimated completion is 2023-08-29.
What interventions are being tested in trial NCT04992520?
The interventions under investigation include: Shigella sonnei 53G (BIOLOGICAL), Shigella flexneri 2a 2457T (BIOLOGICAL).
Who is sponsoring clinical trial NCT04992520?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04992520's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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