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NCT06615375 · ClinicalTrials.gov registry record · Phase 2
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
A Phase 2 study of Shigellosis, sponsored by LimmaTech Biologics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT06615375: Recruiting Phase 2 study of Shigellosis, sponsored by LimmaTech Biologics.
NCT06615375 is a Phase 2 study of Shigellosis that is actively recruiting participants, run by LimmaTech Biologics. The registered enrollment target is 120 participants, above the 50-participant average among 3 other Shigellosis trials with a reported enrollment target (140% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06615375, a Phase 2 study of Shigellosis, is actively recruiting participants, sponsored by LimmaTech Biologics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study Summary
In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain compared to participants receiving placebo.
Primary Outcome
The number of challenged participants with shigellosis post-challenge during the inpatient period that received vaccine compared to participants who received placebo. Shigellosis is defined as: 1. Severe diarrhea; OR 2. Moderate diarrhea AND \[fever OR ≥ 1 at least moderate constitutional/enteric symptoms OR ≥ 2 episodes of vomiting in 24 h\]; OR 3. Dysentery AND \[fever OR ≥ 1 at least moderate constitutional/enteric symptoms OR ≥ 2 episodes of vomiting in 24 h\]
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Shigella4V2
Study Locations (3)
Georgia
- Hope Clinic of Emory University - Atlanta
Maryland
- Johns Hopkins Center for Immunization Research - Baltimore
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-11-12 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT06615375 shows while recruiting
NCT06615375 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 50-participant average among 3 other Shigellosis trials with a reported enrollment target (140% higher).
The record links to 1 condition, with Shigellosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06615375 reports a single indexed study location in Georgia, Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT06615375 about?
NCT06615375 is a clinical study titled "A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine". In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain compared to participants receiving placebo.
What is the current status of trial NCT06615375?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-11-12. Estimated completion is 2026-09.
What conditions does trial NCT06615375 study?
This clinical trial studies the following conditions: Shigellosis.
What interventions are being tested in trial NCT06615375?
The interventions under investigation include: Placebo (BIOLOGICAL), Shigella4V2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06615375?
This trial is sponsored by LimmaTech Biologics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06615375 being conducted?
This trial has 3 study locations across Georgia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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