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

Launched by GEORGE WASHINGTON UNIVERSITY · Jan 20, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how safe and effective it is to intentionally infect healthy adults with a type of worm called Trichuris trichiura, which causes a condition known as whipworm infection. The study will include healthy men and women aged 18 to 45 who have never been infected with this worm. Participants will receive different doses of Trichuris trichiura eggs to see which dose is the safest and leads to a noticeable infection.

If you are eligible and choose to participate, you would need to be available for about 7.5 months and be in good overall health. Certain health conditions, like pregnancy, significant illnesses, or certain medications, would prevent you from joining the study. Throughout the trial, you'll be closely monitored to ensure your safety. This study is still in the planning stages and is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• 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.
• 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.