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

NCT00866476 · 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, a Shigella flexneri 2a live, oral vaccine

CVD 1208S consists of freshly harvested ∆guaBA, ∆sen, ∆set S. flexneri 2a strain 2457T suspended in phosphate buffered saline to reach the desired inoculum Form: liquid Dose: 10 to the 9th power CFU in 1.0 ml Route: oral.

OTHER

Placebo

30 ml of buffer solution (2.0 grams of NaHCO3 dissolved in 150 ml of sterile water) without bacteria, to which food grade corn starch, USP is added, as necessary, to match the turbidity of the vaccine inoculum

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
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 NCT00866476 on ClinicalTrials.gov