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

2014-08-27 03:15:29 | BioPortfolio

Summary

This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers. This study is designed as 2 parts.

- Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14 vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo given with bicarbonate buffer.

- Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10 vaccinees from the first part and 10 naïve controls.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Conditions

Dysentery

Intervention

WRSS1 vaccine candidate, Placebo vaccine

Location

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok
Thailand
10400

Status

Not yet recruiting

Source

U.S. Army Medical Research and Materiel Command

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

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