Controlled Human Infection Model Challenge/Rechallenge (NCT04992520) | Clinical Trial Compass
CompletedPhase 1
Controlled Human Infection Model Challenge/Rechallenge
United States46 participantsStarted 2022-04-26
Plain-language summary
The goal of this study is to better understand Shigella immunity. The study will compare the shigellosis rate in participants previously challenged with a different Shigella serotype to the attack rate in participants not previously exposed to Shigella (naive participants).
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy adults, male or female, aged 18 to 50 years (all inclusive) at the time of enrollment.
✓. General good health, without clinically significant medical history, physical examination findings, or clinical laboratory abnormalities per judgment of Principal Investigator (PI).
✓. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
✓. Completion of a training session and demonstrated comprehension of the protocol procedures and knowledge of Shigella-associated illness by passing a written examination (70% passing score).
✓. Availability for the study duration, including all planned follow-up visits.
✓. Female participants must have a negative pregnancy test at screening and prior to each challenge.
✓. Female participants must agree to avoid pregnancy for 29 days following the last challenge dose by use of an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female participants unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
✓. Willingness to refrain from participation in a study of another investigational agent for 90 days following the last challenge dose.
Exclusion criteria
✕. Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study. Some medical conditions that are adequately treated and stable would not preclude entry into the study.
What they're measuring
1
Percentage of Participants With Shigellosis Following Shigella Challenge
Timeframe: 8 days after challenge administration (Days 1-8 and Days 90-97 for challenge 2)
✕. Clinically significant abnormalities in screening on physical exam or screening laboratory results as determined by PI or PI in consultation with the research monitor and Sponsor.
✕. Recent receipt of another investigational product (within 30 days before enrollment).
✕. Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory tests for human immunodeficiency virus (HIV).
✕. Positive hepatitis C (HCV) ELISA and confirmatory test (e.g., HCV ribonucleic acid (RNA)).
✕. Positive hepatitis B virus surface antigen (HBsAg) by ELISA.
✕. Use of any medication that affects immune function (e.g., corticosteroids and others) within 30 days preceding the first challenge or planned use during the active study period (topical and ophthalmologic steroids are allowable).
✕. Evidence of impaired immune function or immune compromise (known immunodeficiency syndrome; either congenital, acquired, or iatrogenic; active autoimmune disease; repeated serious infections without known cause).