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NCT05706116 · ClinicalTrials.gov registry record · Phase 1
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
A Phase 1 study of Whipworm and Trichuriasis, sponsored by George Washington University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT05706116: Recruiting Phase 1 study of Whipworm and Trichuriasis, sponsored by George Washington University.
NCT05706116 is a Phase 1 study of Whipworm and Trichuriasis that is actively recruiting participants, run by George Washington University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05706116, a Phase 1 study of Whipworm and Trichuriasis, is actively recruiting participants, sponsored by George Washington University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe. The proposed model consists of enrolling consenting, healthy, trichuriasis-naïve adults and challenging them with the investigational product, Trichuris trichiura Egg Inoculum, to assess their ability to result in detectable infection. The proposed study will be a feasibility study that will consist of administering different doses of the Trichuris trichiura Egg Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of T. trichiura eggs) that is safe, well-tolerated and results in consistent infection.
Primary Outcome
Frequency of solicited adverse events, graded by severity, from the day of CHTI through study Day 182.
Conditions Studied
Interventions
- BIOLOGICAL Trichuris trichiura Egg Inoculum
Study Locations (2)
District of Columbia
- George Washington University Medical Faculty Associates - Washington D.C.
Maryland
- NIH Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 1 |
What NCT05706116 shows while recruiting
NCT05706116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Whipworm appearing as the primary indexed condition, and to 1 intervention - of which Trichuris trichiura Egg Inoculum is the first listed.
NCT05706116 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT05706116 about?
NCT05706116 is a clinical study titled "Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults". A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe. The proposed model consists of enrolling consenting, healthy, trichuriasis-naïve adults and challenging ...
What is the current status of trial NCT05706116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-09-10. Estimated completion is 2028-04-30.
What conditions does trial NCT05706116 study?
This clinical trial studies the following conditions: Whipworm, Trichuriasis, Controlled Human Infection.
What interventions are being tested in trial NCT05706116?
The interventions under investigation include: Trichuris trichiura Egg Inoculum (BIOLOGICAL).
Who is sponsoring clinical trial NCT05706116?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05706116 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05706116's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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