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Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults

NCT01509846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-08-11

Study results available
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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.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

Placebo: 1-3 doses

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

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • Clayton D Harro, MD, ScM · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509846 on ClinicalTrials.gov