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ClinicalIndex Comparison Record
Phase 1Completed· 82 enrolled
Drug / intervention
Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01509846
NCT01509846Phase 1Completed
CompareCT.gov

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Oral Inactivated Whole Cell Shigella Flexneri 2a Vaccine in Healthy Adult Subjects

PATH·interventional·Posted Jan 13, 2012·Updated Aug 11, 2021

In Brief

A Phase 1 clinical trial evaluating Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose, Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses, and 3 other interventions for Shigellosis. Completed, enrolled 82 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShigellosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartMar 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.5 years ago

Interventions

Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dosebiological

Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^8 vp/mL administered on Day 0

Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 dosesbiological

Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^9 vp/mL administered on Days 0, 28, and 56

Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 dosesbiological

Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^10 vp/mL administered on Days 0, 28, and 56

Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 dosesbiological

Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10\^11 vp/mL administered on Days 0, 28, and 56

Placebo: 1-3 dosesbiological

Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)