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

Exclusion Criteria20

• 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).
• Positive confirmatory test for HIV infection.
• Positive confirmatory test for hepatitis C virus (HCV) infection.
• 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.
• Known allergy to albendazole.
• History of previous infection with T. trichiura or continuous residence for more than 6 months in a T. trichiura-endemic area.