NCT05706116

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: George Washington University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Open-label, dose-escalation clinical study in healthy, trichuriasis-naïve adults: Study sites: * George Washington University, Washington, DC * Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD * Number of participants: up to 18 in 3 cohorts of 6 volunteers each In Cohort 1, six (6) volunteers will receive an inoculum of 150 embryonated Trichuris trichiura eggs. In Cohort 2, six (6) volunteers will receive an inoculum of 300 embryonated Trichuris trichiura eggs. In the optional Cohort 3, six (6) volunteers will receive an inoculum of 450 embryonated Trichuris trichiura eggs. The cohorts will be enrolled in a staggered fashion with safety data assessed prior to larval dose escalation. Cohort 2 will be inoculated no earlier than 16 weeks after the last volunteer is inoculated in Cohort 1. The optional Cohort 3 will be inoculated no sooner than 16 weeks after the last volunteer is inoculated in Cohort 2. Cohort 3 will be enrolled only if the tolerability of the experimental infection of Cohort 2 is acceptable and does not result in significant adverse events. * Egg administration schedule: Study Day 0 (single administration) * Route: oral * Doses of T. trichiura Egg Inoculum to be tested: 150, 300 and 450 embryonated eggs (high dose optional) * Study duration: approximately 10 months per study participant

Conditions

• Whipworm
• Trichuriasis
• Controlled Human Infection

Interventions

Type	Name	Description
BIOLOGICAL	Trichuris trichiura Egg Inoculum	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.

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-10-23
• Completion: 2028-04-30
• First posted: 2023-01-31
• Last updated: 2025-12-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study