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Safety and Efficacy Challenge Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella: Phase IIb

NCT00866242 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-04-29

No results posted yet for this study

Summary

The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.

Conditions

  • Shigella

Interventions

BIOLOGICAL

CVD 1208S, Challenge strain of wild-type Shigella flexneri 2a

The challenge strain consists of freshly harvested Shigella flexneri 2a strain 2457T diluted in phosphate buffered saline to reach the desired inoculum Form: liquid Dose 10 to the 3rd power CFU in 1.0 ml Route: oral.

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Karen L Kotloff, M.D. · University of Maryland, Baltimore Center for Vaccine Development

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

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 NCT00866242 on ClinicalTrials.gov