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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Trichuris trichiura Egg Inoculum
Biological/VaccineTrichuris 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.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Trichuris trichiura Egg Inoculum 150 eggsExperimental treatment 1 intervention
Group B: Trichuris trichiura Egg Inoculum 300 eggsExperimental treatment 1 intervention
Group C: Trichuris trichiura Egg Inoculum 450 eggsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Solicited adverse events, graded by severity
Frequency of solicited adverse events, graded by severity, from the day of CHTI through study Day 182.
Time frame
Day of CHTI through study Day 1822
Serious Adverse Events
Frequency of CHTI-related Serious Adverse Events from the time of administration of the T. trichiura Egg Inoculum through the final study visit
Time frame
Day of CHTI through final study visit on study Day 2033
Unsolicited adverse events
Frequency of unsolicited adverse events, graded by severity, from the time of CHTI through treatment with albendazole (Day 182)
Time frame
Day of CHTI through study Day 1824
New-onset chronic medical conditions
Frequency of new-onset chronic medical conditions through the final study visit
Time frame
Day of CHTI through final study visit on study Day 203Secondary outcomes
1
Fecal egg detection
Proportion of participants with detectable T. trichiura eggs, at any time point, in fecal samples, as determined by microscopy using the qualified saline flotation technique
Time frame
Day of CHTI through study Day 1822
Fecal egg counts
Fecal egg counts as determined by microscopy using the qualified McMaster method, during Weeks 12 through 26 post-CHTI
Time frame
Weeks 12 through 26 post-CHTI3
T. trichiura DNA in fecal samples
Levels of T. trichiura DNA in fecal samples, as measured by qPCR, during Weeks 12 through 26 post-CHTI
Time frame
Weeks 12 through 26 post-CHTIOther outcomes
1
Serum cytokine concentrations
Serum cytokine concentrations during Weeks 12 through 26 post-CHTI
Time frame
Weeks 12 through 26 post-CHTI2
Cytokine concentrations of supernatants after stimulation of peripheral blood mononuclear cells (PBMCs) with T. trichiura antigen
Cytokine responses to stimulation with T. trichiura and other microbial antigens for total blood cells and peripheral blood monocytes (PBMCs) from the blood
Time frame
Day of CHTI through final study visit on study Day 2033
Fecal microbiome
Microbial communities present in the fecal samples by DNA and/or RNA sequencing analyses prior to and after exposure to T. trichiura Egg Inoculum
Time frame
Day of CHTI through final study visit on study Day 203Sponsors and contacts
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George Washington University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov