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

Eligibility 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.