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NCT05706116

Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults

Recruiting now Phase 1 Last updated 4 December 2025
What this trial tests

Phase 1 trial testing Trichuris trichiura Egg Inoculum in Whipworm in 18 participants. Currently enrolling.

Timeline
10 September 2025
Primary endpoint
23 October 2027
30 April 2028

Quick facts

Lead sponsorGeorge Washington University
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date10 September 2025
Primary completion23 October 2027
Estimated completion30 April 2028
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

George Washington University

Who can join

Adults 18 to 45, any sex, with Whipworm or Trichuriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advances in vaccine development through the controlled human infection models for hookworm and schistosomiasis.
    Hoogerwerf MA, Egesa M, Agnandji ST, Loukas A, et al · · 2026 · PMID 41926449 · DOI 10.1371/journal.pntd.0014137

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