A Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
George Washington University
Summary
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.
Description
Open-label, dose-escalation clinical study in healthy, trichuriasis-naïve adults: Study sites: * George Washington University, Washington, DC * Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD * Number of participants: up to 18 in 3 cohorts of 6 volunteers each In Cohort 1, six (6) volunteers will receive an inoculum of 150 embryonated Trichuris trichiura eggs. In Cohort 2, six (6) volunteers will receive an inoculum of 300 embryonated Trichuris trichiura eggs. In the optional Cohort 3, six (6) volunteers wi…
Eligibility
- Age range
- 18–45 years
- Sex
- All
- Healthy volunteers
- Yes
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. 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 activit…
Interventions
- BiologicalTrichuris trichiura Egg Inoculum
Trichuris trichiura Egg Inoculum that will be used in this study is manufactured by obtaining T. trichiura eggs from the feces of a chronically infected human volunteer, who is negative for HIV, HBV, and HCV. Fecal material is processed following a qualified standard procedure, and after isolating eggs, they are stored at 2-8oC until use. Controls for the manufacturing process are tests for viability (microscopy of larval hatching), species identification (PCR), and microbial bioburden of the eggs.
Locations (2)
- George Washington University Medical Faculty AssociatesWashington D.C., District of Columbia
- NIH Clinical CenterBethesda, Maryland