Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate
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|ClinicalTrials.gov Identifier: NCT01080716|
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : June 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Dysentery Shigella Diarrhea||Biological: WRSS1 vaccine Biological: Placebo vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Safety, Immunogenicity, and Efficacy Studies of WRSS1, a Live Attenuated Shigella Sonnei Vaccine Candidate, in Healthy Thai Adults|
|Study Start Date :||May 2010|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
Experimental: WRSS1 vaccine
WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei
Biological: WRSS1 vaccine
Single, oral dose of WRSS1
Placebo Comparator: Placebo vaccine
Biological: Placebo vaccine
- Number and frequency of adverse events. [ Time Frame: Up to 12 months ]Frequency of any mild, moderate, and severe signs and symptoms associated with the vaccine such as nausea, vomiting, diarrhea, dysentery, fever, abdominal cramping, and dehydration, as well as any unexpected events. Frequency of significant clinical laboratory abnormalities
- Immunogenicity [ Time Frame: Days 0,3,5,7,9,14, and 28 ]
Study Part 1:
Frequency and increase in antigen-specific serum IgG, IgA, and IgM antibody titers to S. sonnei LPS and invaplex-protein antigens. Frequency and increase in antigen-specific fecal IgA antibody titer to S. sonnei LPS and invaplex-protein antigens (study day -1 or 0, study days 3,5,7,14, and 28). Frequency and increase in antigen-specific IgG, IgA, and IgM antibody secreting cells (ASC) and antibody titers in lymphocyte supernatant (ALS) to S. sonnei LPS and invaplex-protein antigens (study days 0,7, and 9).
- Efficacy [ Time Frame: Days 0-5 ]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
- Fecal shedding of vaccine [ Time Frame: Days 0-13 ]
Study Part 1:
Frequency and duration of detectable fecal presence of WRSS1 by PCR and culture
- Transmissibility of WRSS1 to placebo recipients [ Time Frame: Days 0-13 ]
Study Part 1:
Frequency of detectable fecal presence of WRSS1 in placebo recipients by PCR and culture
- Change in clinical laboratory values [ Time Frame: Days 0,7,14, and 28 ]
Study Part 1:
Frequency of clinical laboratory changes, both normal and abnormal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080716
|Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University|
|Bangkok, Thailand, 10400|
|Study Director:||Ladaporn Bodhidatta, MD||Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences|
|Principal Investigator:||Punnee Pitisuttithum, MBBS||Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University|
|Study Director:||Carl Mason, MD||Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences|