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

NCT05706116 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CHTI-01-21
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (11)

• Solicited adverse events, graded by severity

  Frequency of solicited adverse events, graded by severity, from the day of CHTI through study Day 182.

  Day of CHTI through study Day 182

• Serious Adverse Events

  Frequency of CHTI-related Serious Adverse Events from the time of administration of the T. trichiura Egg Inoculum through the final study visit

  Day of CHTI through final study visit on study Day 203

• Unsolicited adverse events

  Frequency of unsolicited adverse events, graded by severity, from the time of CHTI through treatment with albendazole (Day 182)

  Day of CHTI through study Day 182

• New-onset chronic medical conditions

  Frequency of new-onset chronic medical conditions through the final study visit

  Day of CHTI through final study visit on study Day 203

• Adverse Events of Special Interest

  Frequency of Adverse Events of Special Interest through the final study visit

  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

  Frequency of clinical safety laboratory adverse events related to abnormal white blood cell count (unit of measure = cells/mm\^3)

  Day of CHTI through final study visit on study Day 203

• Adverse events related to abnormal clinical safety laboratory parameter (absolute eosinophil count) values

  Frequency of clinical safety laboratory adverse events related to abnormal eosinophil count (unit of measure = cells/mm\^3)

  Day of CHTI through final study visit on study Day 203

• Adverse events related to abnormal clinical safety laboratory parameter (platelet count) values

  Frequency of clinical safety laboratory adverse events related to abnormal platelet count (unit of measure = cells/mm\^3)

  Day of CHTI through final study visit on study Day 203

• Adverse events related to abnormal clinical safety laboratory parameter (hemoglobin concentration) values

  Frequency of clinical safety laboratory adverse events related to abnormal hemoglobin concentration (unit of measure = g/dL)

  Day of CHTI through final study visit on study Day 203

• Adverse events related to abnormal clinical safety laboratory parameter (serum creatinine concentration) values

  Frequency of clinical safety laboratory adverse events related to abnormal serum creatinine concentration (unit of measure = mg/dL)

  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

  Frequency of clinical safety laboratory adverse events related to abnormal serum alanine aminotransferase (ALT) concentration (unit of measure = U/L)

  Day of CHTI through final study visit on study Day 203

Secondary Outcomes (3)

• Fecal egg detection

  Day of CHTI through study Day 182

• Fecal egg counts

  Weeks 12 through 26 post-CHTI

• T. trichiura DNA in fecal samples

  Weeks 12 through 26 post-CHTI

Other Outcomes (3)

• Serum cytokine concentrations

  Weeks 12 through 26 post-CHTI

• Cytokine concentrations of supernatants after stimulation of peripheral blood mononuclear cells (PBMCs) with T. trichiura antigen

  Day of CHTI through final study visit on study Day 203

• Fecal microbiome

  Day of CHTI through final study visit on study Day 203

Study Arms (3)

Trichuris trichiura Egg Inoculum 150 eggs

EXPERIMENTAL

150 Trichuris trichiura eggs

Biological: Trichuris trichiura Egg Inoculum

Trichuris trichiura Egg Inoculum 300 eggs

EXPERIMENTAL

300 Trichuris trichiura eggs

Biological: Trichuris trichiura Egg Inoculum

Trichuris trichiura Egg Inoculum 450 eggs

EXPERIMENTAL

450 Trichuris trichiura eggs

Biological: Trichuris trichiura Egg Inoculum

Interventions

Trichuris trichiura Egg Inoculum BIOLOGICAL

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.

Trichuris trichiura Egg Inoculum 150 eggs; Trichuris trichiura Egg Inoculum 300 eggs; Trichuris trichiura Egg Inoculum 450 eggs

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
• 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.
• Currently lactating and breast-feeding (if female).
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
• 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).
• Known or suspected immunodeficiency or immunosuppression as a result of an underlying illness or treatment.
• Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
• Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit).
• 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).
• Positive fecal occult blood test.
• Infection with a pathogenic intestinal helminth as determined by stool examination for ova and parasites.
• History of iron deficiency anemia or laboratory evidence of iron deficiency (serum ferritin concentration below the lower reference limit).
• 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.
• Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 24 months.
• Positive ELISA for hepatitis B surface antigen (HBsAg).

Sponsors & Collaborators

• George Washington University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

George Washington University Medical Faculty Associates

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

RECRUITING

NIH Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

MeSH Terms

Conditions

Trichuriasis

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Central Study Contacts

David Diemert, MD

CONTACT

202-994-2909; ddiemert@gwu.edu

Laura Vasquez, MPH

CONTACT

202-994-1599; lvasquez@gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 31, 2023
• Study Start: September 10, 2025
• Primary Completion (Estimated): October 23, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)