Recruiting
Phase 1

Trichuris trichiura

Sponsor:

George Washington University

Code:

NCT05706116

Conditions

Whipworm

Trichuriasis

Controlled Human Infection

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Trichuris trichiura Egg Inoculum

Study Details

Brief 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.

Conditions

Whipworm

Trichuriasis

Controlled Human Infection

Study ID

NCT05706116

Start date

Sep 10, 2025

Status verified date

Jun, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Oct 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Males or females between 18 and 45 years, inclusive.
2. Good general health as determined by means of the screening procedures.
3. Available for the duration of the trial (approximately 7.5 months).
4. Willingness to participate in the study as evidenced by signing the informed consent document.
5. Ability to sign and understand the informed consent document.

Exclusion Criteria:

1. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
2. Participant unwilling to use reliable contraception methods while participating in the study (if female of reproductive potential who is engaging in sexual activity that could lead to pregnancy); being of reproductive potential is defined as not being surgically sterile, abstinent from intercourse with a male partner, in a monogamous relationship with a vasectomized partner, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile.
3. Currently lactating and breast-feeding (if female).
4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
5. Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).
6. Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment.
7. Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
8. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit).
9. Laboratory evidence of hematologic disease (hemoglobin <11.1 g/dl \[females\] or <12.5 g/dl \[males\]; absolute leukocyte count <3.4 or >11.0 x 103/mm3; absolute eosinophil count >0.6 x 103/mm3 or platelet count <125 x 103/mm3).
10. Positive fecal occult blood test.
11. Infection with a pathogenic intestinal helminth as determined by stool examination for ova and parasites.
12. History of iron deficiency anemia or laboratory evidence of iron deficiency (serum ferritin concentration below the lower reference limit).
13. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the participant unable to comply with the protocol.
14. Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 24 months.
15. Positive ELISA for hepatitis B surface antigen (HBsAg).
16. Positive confirmatory test for HIV infection.
17. Positive confirmatory test for hepatitis C virus (HCV) infection.
18. Using or intends to continue using oral or parenteral corticosteroids, high-dose inhaled corticosteroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs within 30 days of the volunteer's expected enrollment in this study or planned use during the study.
19. Known allergy to albendazole.
20. History of previous infection with T. trichiura or continuous residence for more than 6 months in a T. trichiura-endemic area.
21. Inability to speak English.
22. Current/planned simultaneous participation in another study of an investigational agent or device for the duration of their study participation.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

Primary outcome measure

  • Solicited adverse events, graded by severity [ Time Frame: Day of CHTI through study Day 182 ]
  • Serious Adverse Events [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Unsolicited adverse events [ Time Frame: Day of CHTI through study Day 182 ]
  • New-onset chronic medical conditions [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Adverse Events of Special Interest [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Adverse events related to abnormal clinical safety laboratory parameter (white blood cell count) values [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Adverse events related to abnormal clinical safety laboratory parameter (absolute eosinophil count) values [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Adverse events related to abnormal clinical safety laboratory parameter (platelet count) values [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Adverse events related to abnormal clinical safety laboratory parameter (hemoglobin concentration) values [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Adverse events related to abnormal clinical safety laboratory parameter (serum creatinine concentration) values [ Time Frame: Day of CHTI through final study visit on study Day 203 ]
  • Adverse events related to abnormal clinical safety laboratory parameter (serum alanine aminotransferase concentration) values [ Time Frame: Day of CHTI through final study visit on study Day 203 ]

Central Contacts and Locations

Central contacts

Locations

George Washington University Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Caroline Thoreson, PA-C

202-741-2443gwvru@gwu.edu

Principal Investigator:

David J Diemert, MD

NIH Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Principal Investigator:

Thomas Nutman, MD

More Information

Sponsor

George Washington University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2026-06-04.