Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02388009 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
A Phase 1 study of Shigellosis, sponsored by LimmaTech Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02388009: Completed Phase 1 study of Shigellosis, sponsored by LimmaTech Biologics.
NCT02388009 is a Phase 1 study of Shigellosis that has completed, run by LimmaTech Biologics. The registered enrollment target is 30 participants, below the 80-participant average among 3 other Shigellosis trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388009, a Phase 1 study of Shigellosis, has completed, sponsored by LimmaTech Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
Primary Outcome
Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Flexyn2a
- BIOLOGICAL Flexyn2a plus adjuvant
Study Locations (1)
Maryland
- WRAIR Clinical Trial Center (CTC) - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT02388009 record still lists
NCT02388009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 80-participant average among 3 other Shigellosis trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Shigellosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02388009 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02388009 about?
NCT02388009 is a clinical study titled "Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a". This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
What is the current status of trial NCT02388009?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-02. Estimated completion is 2015-09.
What conditions does trial NCT02388009 study?
This clinical trial studies the following conditions: Shigellosis.
What interventions are being tested in trial NCT02388009?
The interventions under investigation include: Placebo (BIOLOGICAL), Flexyn2a (BIOLOGICAL), Flexyn2a plus adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT02388009?
This trial is sponsored by LimmaTech Biologics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02388009 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Shigellosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
ACTIVE NOT RECRUITING · Phase 1
-
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
RECRUITING · Phase 2
-
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia