Study Summary
This trial will compare the rate of shigellosis in people who have been previously infected with a different strain of Shigella to the rate of infection in people who have not been infected before.
Eligible Conditions
- Shigellosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 11 days after challenge administration
Day 11
Number of Participants With Shigellosis
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Group 2A: S. flexneri 2a 2457T (1500 cfu)
1 of 4
Group 1B: S. flexneri 2a 2457T
1 of 4
Group 1A: S. sonnei 53G
1 of 4
Group 2B: S. sonnei 53G
1 of 4
Experimental Treatment
80 Total Participants · 4 Treatment Groups
Primary Treatment: S. sonnei 53G · No Placebo Group · Phase 1
Group 2A: S. flexneri 2a 2457T (1500 cfu)
Biological
Experimental Group · 1 Intervention: S. flexneri 2a 2457T · Intervention Types: BiologicalGroup 1B: S. flexneri 2a 2457T
Biological
Experimental Group · 1 Intervention: S. flexneri 2a 2457T · Intervention Types: BiologicalGroup 1A: S. sonnei 53G
Biological
Experimental Group · 1 Intervention: S. sonnei 53G · Intervention Types: BiologicalGroup 2B: S. sonnei 53G
Biological
Experimental Group · 1 Intervention: S. sonnei 53G · Intervention Types: BiologicalTrial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 11 days after challenge administration
Who is running the clinical trial?
PATHLead Sponsor
161 Previous Clinical Trials
633,776 Total Patients Enrolled
1 Trials studying Shigellosis
82 Patients Enrolled for Shigellosis
Johns Hopkins University Center for Immunization Research (CIR)UNKNOWN
United States Department of DefenseFED
779 Previous Clinical Trials
202,339 Total Patients Enrolled
Kawsar Talaat, MDPrincipal InvestigatorJohns Hopkins University
11 Previous Clinical Trials
790 Total Patients Enrolled
Eligibility Criteria
Age 18 - 50 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have completed a training session and demonstrated comprehension of the protocol procedures and knowledge of Shigella-associated illness by passing a written examination.
Female participants must have a negative pregnancy test at screening and prior to each challenge.
You are willing to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
You are available for the study duration.
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
You are willing to refrain from participating in a study of another investigational agent for 90 days following the last challenge dose.
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Conditions
Cancer Related
Treatments