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Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
Sponsor: George Washington University
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
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