Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05706116
PHASE1

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

Sponsor: George Washington University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-09-10

Completion Date

2028-04-30

Last Updated

2025-12-04

Healthy Volunteers

Yes

Interventions

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.

Locations (2)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

NIH Clinical Center

Bethesda, Maryland, United States