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NCT02646371 · ClinicalTrials.gov registry record · Phase 2
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
A Phase 2 study of Shigellosis, sponsored by LimmaTech Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT02646371: Completed Phase 2 study of Shigellosis, sponsored by LimmaTech Biologics.
NCT02646371 is a Phase 2 study of Shigellosis that has completed, run by LimmaTech Biologics. The registered enrollment target is 67 participants, roughly in line with the 67-participant average among 3 other Shigellosis trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02646371, a Phase 2 study of Shigellosis, has completed, sponsored by LimmaTech Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving placebo.
Primary Outcome
The attack rate of shigellosis after challenge in vaccine group versus in placebo group was analyzed.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Flexyn2a
Study Locations (1)
Maryland
- Johns Hopkins Bloomberg School of Public Health, CIR - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-07 |
| Phase | Phase 2 |
What the finished NCT02646371 record still lists
NCT02646371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, roughly in line with the 67-participant average among 3 other Shigellosis trials with a reported enrollment target.
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.
NCT02646371 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02646371 about?
NCT02646371 is a clinical study titled "Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a". In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving placebo.
What is the current status of trial NCT02646371?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2015-12. Estimated completion is 2017-07.
What conditions does trial NCT02646371 study?
This clinical trial studies the following conditions: Shigellosis.
What interventions are being tested in trial NCT02646371?
The interventions under investigation include: Placebo (BIOLOGICAL), Flexyn2a (BIOLOGICAL).
Who is sponsoring clinical trial NCT02646371?
This trial is sponsored by LimmaTech Biologics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02646371 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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