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NCT04242264 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Shigella Vaccine and Challenge
A Phase 2 study of Shigella Infection and Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 2
- Study locations
NCT04242264: Completed Phase 2 study of Shigella Infection and Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04242264 is a Phase 2 study of Shigella Infection and Immunisation that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04242264, a Phase 2 study of Shigella Infection and Immunisation, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a trial to evaluate the safety, reactogenicity, immunogenicity and efficacy of a 10\^6 cfu dose of an oral live-attenuated S. sonnei vaccine candidate, WRSs2, in up to 120 healthy males and non-pregnant females aged 18-49, inclusive. This is a two-phase study, an outpatient WRSs2 vaccination phase and an inpatient S. sonnei 53G challenge phase. After the initiation of the study, two participants had Grade 3 diarrhea and/or vomiting in the days following vaccination. The vaccination dose was reduced to 5X10\^5, enrollment was changed to 2 arms and randomized 2:1 (vaccine: placebo). Participants with morbid obesity were excluded and weight loss medications prohibited. The Primary Objective of this study is to estimate combined vaccine efficacy of 2 doses of WRSs2 (10\^6 cfu or 5X10\^5 cfu) in preventing shigellosis, following challenge with S. sonnei strain 53G.
Primary Outcome
Following study vaccination on Days 1 and 29, participants were admitted to an inpatient facility and challenged with Shigella sonnei strain 53G on Day 57. From challenge through Day 63, all stools passed by challenged participants were graded for consistency, all grade 3-5\* stools were visually assessed for gross blood, and all gross blood-containing stools were confirmed via hemoccult test. A blinded endpoint review committee of independent Shigella experts determined whether shigellosis occu
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Shigella sonnei strain 53G
- BIOLOGICAL WRSs2
Study Locations (2)
Georgia
- The Hope Clinic of Emory University - Decatur
Ohio
- Cincinnati Children's Hospital Medical Center Vaccine Research Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2024-07-08 |
| Phase | Phase 2 |
What the finished NCT04242264 record still lists
NCT04242264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Shigella Infection appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04242264 reports a single indexed study location in Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT04242264 about?
NCT04242264 is a clinical study titled "Phase 2 Shigella Vaccine and Challenge". This is a trial to evaluate the safety, reactogenicity, immunogenicity and efficacy of a 10\^6 cfu dose of an oral live-attenuated S. sonnei vaccine candidate, WRSs2, in up to 120 healthy males and non-pregnant females aged 18-49, inclusive. This is a two-phase study, an outpatient WRSs2 vaccination...
What is the current status of trial NCT04242264?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2022-10-12. Estimated completion is 2024-07-08.
What conditions does trial NCT04242264 study?
This clinical trial studies the following conditions: Shigella Infection, Immunisation.
What interventions are being tested in trial NCT04242264?
The interventions under investigation include: Placebo (OTHER), Shigella sonnei strain 53G (BIOLOGICAL), WRSs2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04242264?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04242264 being conducted?
This trial has 2 study locations across Georgia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04242264's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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