S. sonnei 53G for Shigellosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ShigellosisS. sonnei 53G - Biological
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

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

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 11 days after challenge administration

Day 11
Number of Participants With Shigellosis

Trial Safety

Safety Progress

1 of 3

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: Biological
Group 1B: S. flexneri 2a 2457T
Biological
Experimental Group · 1 Intervention: S. flexneri 2a 2457T · Intervention Types: Biological
Group 1A: S. sonnei 53G
Biological
Experimental Group · 1 Intervention: S. sonnei 53G · Intervention Types: Biological
Group 2B: S. sonnei 53G
Biological
Experimental Group · 1 Intervention: S. sonnei 53G · Intervention Types: Biological

Trial 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.