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Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines: WRSs2 and WRSs3

NCT01336699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2019-01-28

No results posted yet for this study

Summary

Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age (inclusive) will be screened. Enroll serial groups up to 90 subjects. The primary objective is to evaluate safety and tolerance of WRSs2 by monitoring presence, frequency and severity of clinical signs and symptoms. A secondary objective is to evaluate the immune response in blood and stool following ingestion of WRSs2 and WRSs3.

Conditions

  • Shigella Infection

Interventions

OTHER

Placebo

Placebo comparator: 1 or 1.5 ml of sterile normal saline 0.9% added to 30 mL of 0.9% sterile normal saline, given orally.

BIOLOGICAL

WRSs2

WRSs2 is a live, attenuated Shigella sonnei vaccine product, given orally at five escalating doses from 1x10\^3 colony-forming units (cfu) to 1x10\^7 cfu.

BIOLOGICAL

WRSs3

WRSs3 is a live, attenuated Shigella sonnei vaccine product, given orally at five escalating doses from 1x10\^3 colony-forming units (cfu) to 1x10\^7 cfu.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-07
Primary Completion
2015-05-12
Completion
2015-05-12
FDA Drug
Yes

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 NCT01336699 on ClinicalTrials.gov