Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh (SCVB)
Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional epidemics seen during times of floods, cyclones or any natural disaster. It affects all age groups with the majority of fatal cases occurring in children . Therefore, immunization against cholera remains an important public health component in the prevention and control of the disease .The current two-dose regimen of the internationally available oral cholera vaccines (OCV) create a logistical and programmatic challenge for use in national programs or during epidemics ,so it is important to determine if a single dose vaccine will be protective in regions where cholera is endemic. If the vaccine is found to be efficacious following a single dose, this will have profound implications for the use of the vaccine in areas with limited resources particularly in complex emergencies where a multiple dose regimen is difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability' and allow the vaccine to be used for outbreak control, especially in difficult settings where the risk of cholera is extremely high and provisions for clean water and sanitation are not available. With low OCV production rates, larger populations could be immunized against cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate the inclusion of a global stockpile strategy.
The study design is a two-arm individually randomized double-blind placebo-controlled trial. The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study treatment centres from 7 days to 6 months after dosage and whose identity is confirmed through home visit.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||An Individually Randomized, Placebo-controlled Trial to Measure the Protection Conferred by a Single Dose Regimen of Bivalent, Killed, Whole Cell Oral Cholera Vaccine (Shanchol™) in Dhaka, Bangladesh|
- Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Shanchol vaccine will be given to healthy, non-pregnant residents aged one and above in Dhaka, Bangladesh, against culture-proven V. cholerae O1 diarrhea which has been detected in all treatment settings serving the catchment population.
- Number of participants with a single dose Shanchol with onset of 7 days to to 24 months after dosing, against culture-proven V. cholerae O1 diarrhea, V. Cholerae O1 along and with severe dehydration get protection [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Number of participants with the single dose regimen of Shanchol against acute watery diarrhea and AWD with severe dehydration with onset of 7 days to 24 months after dosing get protection [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Serum vibriocidal antibody responses to a single dose regimen of the bivalent, killed, whole cell-based oral cholera vaccine Shanchol in healthy,non-pregnant residents, aged one year and older in a subset of population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Safety up to 28 days following a single dose of the bivalent, killed, whole cell oral cholera vaccine Shanchol™ administered to healthy, non-pregnant residents one year and older. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
We will use the killed whole cell oral cholera vaccine, Shanchol that will be manufactured by Shantha Biotechnics, in Hyderabad, India for the study. The vaccine is registered in India and is prequalified by the WHO. Shanchol is available in a single dose vial. Vaccine will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive vaccine.Pregnancy status will be enquired verbally for all married women of child bearing age during the census update as well as before vaccination to exclude them from the study.
Prior to vaccination, informed consent will be taken from the adults and guardians of minor participants .Each dose of vaccine will be 1.5 ml in volume.
|Placebo Comparator: Placebo||
Placebo will be transported from the manufacturer and will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive placebo.Each dose of placebo will be 1.5 ml in volume.Placebo will be dispensed in liquid form in identical vials.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02027207
|Contact: Dr. Firdausi Qadri, PhD||88-02-9840525 ext firstname.lastname@example.org|
|International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)||Recruiting|
|Dhaka, Bangladesh, 1212|
|Contact: Dr. Firdausi Qadri, PhD 88-02-9840525 ext 2431 email@example.com|