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Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP

NCT01531530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-04-30

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, a Shigella flexneri 2a live, oral vaccine

The vaccine is mixed with salt water and given by mouth.

OTHER

Placebo

Corn starch and baking soda are mixed with salt water and given by mouth.

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
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

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 NCT01531530 on ClinicalTrials.gov