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

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.

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 \