RECRUITING

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

Conditions

Whipworm Trichuriasis Controlled Human Infection

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07

Study Completion:2028-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05706116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

David Diemert, MD

CONTACT

202-994-2909

ddiemert@gwu.edu

Laura Vasquez, MPH

CONTACT

202-994-1599

lvasquez@gwu.edu

Study Locations (Sites)

George Washington University Medical Faculty Associates

Washington, District of Columbia, 20037

United States

NIH Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: George Washington University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2028-04-30

Study Record Updates

Study Start Date2025-07

Study Completion Date2028-04-30

Terms related to this study

Additional Relevant MeSH Terms

Whipworm
Trichuriasis
Controlled Human Infection