Diarrhea Clinical Trial
Official title:
Safety, Immunogenicity, and Efficacy Studies of WRSS1, a Live Attenuated Shigella Sonnei Vaccine Candidate, in Healthy Thai Adults
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.
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