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NCT01509846 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
A Phase 1 study, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT01509846 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 82 participants.
The verdict
NCT01509846, a Phase 1 study, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC). Sf2aWC is a killed vaccine that is being made to prevent disease from Shigella., which causes bloody, watery diarrhea. Infants and children living in developing countries experience the greatest consequences of this disease. The purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops an immune response. About 82 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights for the first dose. Participants in Cohorts 2, 3, and 4 will not be required to stay overnight for the second and third doses. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples and documenting side effects. Participants will be involved in study related procedures for about 8 months.
Interventions
- BIOLOGICAL Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose
- BIOLOGICAL Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses
- BIOLOGICAL Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses
- BIOLOGICAL Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses
- BIOLOGICAL Placebo: 1-3 doses
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01509846
The ClinicalTrials.gov registry entry for NCT01509846 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PATH, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose is the first listed.
NCT01509846 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01509846 about?
NCT01509846 is a clinical study titled "Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults". This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC). Sf2aWC is a killed vaccine that is being made to prevent disease from Shigella., which causes bloody, watery diarrhea. Infants and children living in developing ...
What is the current status of trial NCT01509846?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2011-03. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01509846?
The interventions under investigation include: Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose (BIOLOGICAL), Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses (BIOLOGICAL), Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses (BIOLOGICAL), Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses (BIOLOGICAL), Placebo: 1-3 doses (BIOLOGICAL).
Who is sponsoring clinical trial NCT01509846?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
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