Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorGeorge Washington University
About this trial
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.
Eligibility criteria
Qualifiers
Males or females between 18 and 45 years, inclusive.
Good general health as determined by means of the screening procedures.
Available for the duration of the trial (approximately 7.5 months).
Willingness to participate in the study as evidenced by signing the informed consent document.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Trichuris trichiura Egg Inoculum
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
George Washington University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov