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Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate

NCT01080716 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-13

Study results available
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Summary

This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers.

Conditions

Interventions

BIOLOGICAL

Part 1/Arm 1 of Study: WRSS1 vaccine

Single, oral dose of WRSS1

BIOLOGICAL

Part 1/Arm 2 of Study: Placebo vaccine

Placebo vaccine

BIOLOGICAL

Part 2/Arm 1 of Study: S. sonnei 53G

Subject from Part 1/Arm 1 of Study are given 53G S. sonnei

BIOLOGICAL

Part 2/Arm 2 of Study: S. sonnei 53G

10 naïve controls are given S. sonnei 53G

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Ladaporn Bodhidatta, MD · Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences

  • Punnee Pitisuttithum, MBBS · Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

  • Carl Mason, MD · Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-09-30
Completion
2011-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT01080716 on ClinicalTrials.gov