Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh (SCVB)
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|ClinicalTrials.gov Identifier: NCT02027207|
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : March 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholera||Biological: Shanchol Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204438 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||December 9, 2012|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||December 31, 2017|
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.
- Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection [ Time Frame: 7 days to 6 months ]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 get protection with a single dose Shanchol after dosing against culture-proven V. cholerae O1 diarrhea [ Time Frame: 7 days to 24 months ]Number of participants with a single dose Shanchol with onset of 7 days to 12 months, from 7 days to 18 months and 7 days to 24 months after dosing against culture-proven V. cholerae O1 diarrhea detected in treatment centre
- Number of participants get protection with the single dose regimen of Shanchol against culture proven V. Cholerae O1 diarrhea with severe dehydration, V. Cholerae O139 diarrhea,V. Cholerae O139 diarrhea with severe dehydration . [ Time Frame: 7 days to 24 months ]Number of participants with the single dose regimen of Shanchol against culture proven V. Cholerae O1 diarrhea with severe dehydration, V. Cholerae O139 diarrhea,V. Cholerae O139 diarrhea with severe dehydration with onset from 7 days to 12 months, from 7 days to 18 months and from 7 days to 24 months after dosing
- Number of participants with a single dose Shanchol with onset of 7 days to 6 months,7 days to 12 months, from 7 days to 18 months and 7 days to 24 months after dosing against acute watery diarrhoea detected in treatment centre [ Time Frame: 7 days to 24 months ]
- Number of participants with a single dose Shanchol with onset of 7 days to 6 months,7 days to 12 months, from 7 days to 18 months and 7 days to 24 months after dosing against acute watery diarrhea with severe dehydration detected in treatment centre [ Time Frame: 7 days to 24 months ]
- Serum vibriocidal antibody responses to oral cholera vaccine Shanchol in healthy,non-pregnant residents, aged one year and older in a subset of population [ Time Frame: 14 days ]Serum vibriocidal (To El Tor Inaba and ogawa serogroup O1 and to serogroup O139) 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
- 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: 28 days ]
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): NCT02027207
|International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)|
|Dhaka, Bangladesh, 1212|