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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• Males or females between 18 and 45 years, inclusive.

• Good general health as determined by means of the screening procedures.

• Available for the duration of the trial (approximately 7.5 months).

• Willingness to participate in the study as evidenced by signing the informed consent document.

Locations
United States
Washington, D.c.
George Washington University Medical Faculty Associates
RECRUITING
Washington D.c.
Maryland
NIH Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
David Diemert, MD
ddiemert@gwu.edu
202-994-2909
Backup
Laura Vasquez, MPH
lvasquez@gwu.edu
202-994-1599
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 18
Treatments
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
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: George Washington University

This content was sourced from clinicaltrials.gov