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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: Completed Phase 1 study, sponsored by PATH.
NCT01509846 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Local and systemic reactogenicity was assessed post-vaccination using targeted physical examinations, vital signs and clinical laboratory tests, and diary cards (completed following discharge daily through Day 7). Reactogenicity included: nausea, vomiting, fever, abdominal pain, abdominal cramping, bloating, malaise, headache, decreased appetite, generalized myalgias, chills, light-headedness, constipation, excessive flatulence, reactive arthritis, dysentery, loose stool, diarrhea, hypovolemia,
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 |
What the finished NCT01509846 record still lists
NCT01509846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01509846's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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