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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01080716
Other study ID # A-15647
Secondary ID 09-00211609
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2010
Est. completion date December 2011

Study information

Verified date October 2018
Source U.S. Army Medical Research and Materiel Command
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Part 1/Arm 1 of Study: WRSS1 vaccine
Single, oral dose of WRSS1
Part 1/Arm 2 of Study: Placebo vaccine
Placebo vaccine
Part 2/Arm 1 of Study: S. sonnei 53G
Subject from Part 1/Arm 1 of Study are given 53G S. sonnei
Part 2/Arm 2 of Study: S. sonnei 53G
10 naïve controls are given S. sonnei 53G

Locations

Country Name City State
Thailand Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University Bangkok

Sponsors (3)

Lead Sponsor Collaborator
U.S. Army Medical Research and Materiel Command Mahidol University, National Institutes of Health (NIH)

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events Overview of AEs highlighting all AEs, withdrawals and deaths related to AEs Up to 12 months
Primary Number of Participants With Shigella Induced Clinical Disease in Part 2 Study Part 2-Frequency of Shigella induced clinical disease defined as one or more of diarrhea, dysentery or fever in vaccinees and controls following challenge with S. sonnei 53G. Transmissibility of disease will be evaluated by the presence of fecal shedding in control subjects. 0-5 days
Secondary Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI Days 1, 7, 14, and 28
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