A 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.
• 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.