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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT05706116
Phase
PHASE1
Status
Recruiting
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Conditions

  • Controlled Human Infection
  • Trichuriasis
  • Whipworm

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Trichuris trichiura Egg Inoculum — BIOLOGICAL
    Trichuris trichiura Egg Inoculum that will be used in this study is manufactured by obtaining T. trichiura eggs from the feces of a chronically infected human volunteer, who is negative for HIV, HBV, and HCV. Fecal material is processed following a qualified standard procedure, and after isolating eggs, they are stored at 2-8oC until use. Controls for the manufacturing process are tests for viability (microscopy of larval hatching), species identification (PCR), and microbial bioburden of the eggs.

Study Details

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.

Key Dates

Start date
Sep 10, 2025
Status verified
Jun 2026
Primary completion
Oct 23, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trichuris trichiura Egg Inoculum 150 eggs
    150 Trichuris trichiura eggs
  • Experimental: Trichuris trichiura Egg Inoculum 300 eggs
    300 Trichuris trichiura eggs
  • Experimental: Trichuris trichiura Egg Inoculum 450 eggs
    450 Trichuris trichiura eggs

Primary Outcome Measure

Solicited adverse events, graded by severity [ Time Frame: Day of CHTI through study Day 182 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
George Washington University Medical Faculty AssociatesWashington D.C.District of Columbia20037
Caroline Thoreson, PA-C
[email protected]
202-741-2443
David J Diemert, MD (PRINCIPAL_INVESTIGATOR)
NIH Clinical CenterBethesdaMaryland20892
Thomas Nutman, MD
[email protected]
301-496-5399
Thomas Nutman, MD (PRINCIPAL_INVESTIGATOR)

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By research site
George Washington University Medical Faculty Associates· Washington D.C., DCNIH Clinical Center· Bethesda, MD