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Bacteria

S. sonnei 53G for Shigellosis

Phase 1
Waitlist Available
Led By Kawsar Talaat, MD
Research Sponsored by PATH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 days after challenge administration
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 days after challenge administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 days after challenge administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Shigellosis

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 2B: S. sonnei 53GExperimental Treatment1 Intervention
At least 3 months after challenging Group 2A, 20 of those volunteers, along with 10 newly recruited naïve participants, will be challenged with 1500 cfu of S. sonnei 53G Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 2 minutes.
Group II: Group 2A: S. flexneri 2a 2457T (1500 cfu)Experimental Treatment1 Intervention
30 naïve participants will be challenged with 1500 colony forming units (cfu) of S. flexneri 2a Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 2 minutes.
Group III: Group 1B: S. flexneri 2a 2457TExperimental Treatment1 Intervention
At least 3 months after challenging Group 1A, 20 of those volunteers, along with 10 newly recruited naïve participants, will be challenged with 1500 cfu of S. flexneri 2a Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 2 minutes.
Group IV: Group 1A: S. sonnei 53GExperimental Treatment1 Intervention
30 naïve participants will be challenged with 1500 colony forming units (cfu) of S. sonnei 53G Mode of Administration: After a 90 minute fast subjects will drink the 120 mL of sodium bicarbonate (to neutralize gastric acidity) and then drink the challenge suspension within 2 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S. sonnei 53G
2022
Completed Phase 1
~50
S. flexneri 2a 2457T
2022
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PATHLead Sponsor
171 Previous Clinical Trials
606,239 Total Patients Enrolled
3 Trials studying Shigellosis
237 Patients Enrolled for Shigellosis
United States Department of DefenseFED
855 Previous Clinical Trials
225,400 Total Patients Enrolled
Johns Hopkins University Center for Immunization Research (CIR)UNKNOWN

Media Library

S. flexneri 2a 2457T (Bacteria) Clinical Trial Eligibility Overview. Trial Name: NCT04992520 — Phase 1
Shigellosis Research Study Groups: Group 2B: S. sonnei 53G, Group 1A: S. sonnei 53G, Group 1B: S. flexneri 2a 2457T, Group 2A: S. flexneri 2a 2457T (1500 cfu)
Shigellosis Clinical Trial 2023: S. flexneri 2a 2457T Highlights & Side Effects. Trial Name: NCT04992520 — Phase 1
S. flexneri 2a 2457T (Bacteria) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04992520 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators currently recruiting for this trial?

"The trial is still recruiting participants and the particulars are listed on clinicaltrials.gov, with an initial posting date of April 26th 2022 and a final edit date of April 18th 2022."

Answered by AI

How many individuals have been inducted into the research project thus far?

"Indeed, clinicaltrials.gov confirms that the clinical trial is actively recruiting participants since it was first published on April 26th 2022 and last updated on April 18th 2022. 80 patients are being recruited through a single site for this study."

Answered by AI

Has the Food and Drug Administration approved S. sonnei 53G?

"The limited data available on S. sonnei 53G's efficacy and safety merit a score of 1 when assessing its risk profile."

Answered by AI

What criteria must participants satisfy to join this medical trial?

"80 patients of ages 18 to 50, who have been diagnosed with shigellosis, are eligible for admittance in this trial."

Answered by AI

Do participants of this research study need to be under 40 years old?

"The requirements for enrollment in this trial specify that the minimum age is 18, while participants must not exceed 50 years old."

Answered by AI
~16 spots leftby Mar 2025