An observational study in Cholera, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 1 Year to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-20.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Observational
To evaluate the preventive impact, demand, acceptability, uptake, feasibility, and cost-effectiveness of a two-dose regimen of the OCV Shanchol in children living in urban slums in Bangladesh, Investigators will conduct a targeted mass immunization programme, using an innovative approach successfully deployed by the Bangladesh government in its recent countrywide campaign of MR vaccination of 52 million children aged 9 months to 14 years (\<15 years). Investigators will undertake a census of a geographic population of approximately 300,000 persons, with GIS locations of each household. This census will be updated every 6 months during the follow-up period to permit tracking of births, deaths, and migrations, including changes in location of each individual's residence. Following the initial census, the OCV will be offered to all non-pregnant individuals aged 1 to 14 years. Operational research and economic studies will evaluate the coverage, feasibility, acceptability, demand, costs and cost-effectiveness of this vaccination programme.
Burden: Cholera remains a major global problem, resulting in more than 100,000 deaths and several million cases annually , mostly children. Vaccination has been reconsidered as a key component of the public health response to cholera. Bangladesh has one of the world's highest burdens of endemic cholera, with an estimated 300,000 cholera cases and over 4,500 deaths annually, and with high caseloads and frequent outbreaks in more than half of the country. The endemicity of cholera in Bangladesh is demonstrated by the predictable yearly occurrence of the disease in the country's high-risk districts and the repetitive seasonal pattern of cholera outbreaks, either in spring or autumn, or both .
Knowledge gap: More evidence is needed to address uncertainties around the cholera disease burden, as well as the impact, feasibility, and cost-effectiveness of various vaccination strategies against cholera, to add to the existing knowledge base. A special need for acquiring field evidence of these vaccine attributes in settings with endemic cholera, which account for a very large fraction of the global cholera disease burden, is also recognized .
Relevance: Nonetheless, the assertion that selective vaccination of children with OCV is an impactful approach to controlling cholera at the population level rests on unproven assumptions, since there are no studies that directly address this vaccination strategy. Therefore, further study on whether targeted mass immunization can create efficiencies that general mass immunization would not, is warranted. The Investigators therefore believe that the most compelling question for the control of endemic cholera in Bangladesh is how targeting 1-14 year olds in urban slums, using the established platform of targeted mass childhood immunization recently deployed by the GOB for measles-rubella (MR) vaccine, impacts on the overall burden of cholera in the population and how feasible and cost-effective this strategy is. Addressing these questions will add to the evidence base on the most cost efficient and effective settings and strategies for use of OCV to control endemic disease and optimize health impact.
Hypothesis : Vaccination of children under 15 years of age in urban slums of Dhaka will confer at least 50% overall protection to the entire population through combined direct and indirect protective effects and it will be cost effective.
Objectives:To evaluate the feasibility, efficiency, and impact of a two-dose regimen of the oral cholera vaccine (OCV) Shanchol delivered to children aged 1-14 years residing in urban slums, leveraging a targeted mass immunization delivery platform used for other vaccines in Bangladesh.
Methods: Observational design based on the contrast of persons who do and do not get vaccinated according to public health practice(Age-targeted mass immunization program).
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
Browse Cholera studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 206 studies on the registry; 31 are open to participants now.
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The study population will be recruited from different wards of Dhaka city corporation (wards 42, 43, 45, 46, 47, 48, 58, 91 and 92 which are now numbered as 29,30,32,33,34 of Dhaka North City Corporation and 14,22,55,56,57 of Dhaka South City Corporation respectively).
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Exclusion Criteria:
Oral Cholera Vaccine
Number of participants with two doses of oral cholera vaccine (Shanchol) will get protection
Shanchol vaccine will be given to healthy , non pregnant residents aged 1-14 years in Dhaka, Bangladesh against culture proven vibrio cholerae O1 diarrhoea which has been detected in all treatment settings serving the catchment population.
Time frame: 2 years from dosing
Cholera vaccine coverage
Vaccination status of children by age, sex, socioeconomic characteristics of the household evaluation
Time frame: 10 months
Vaccine acceptability
Exit interviews with caregivers, direct observation of vaccination sessions, in-depth interviews and focus groups with guardians of vaccine recipients and of children not receiving vaccine will be conducted using qualitative guidelines to evaluate the taste of the vaccine, the convenience of the vaccine delivery program, willingness to participate in similar future vaccination programmes,general concerns about the vaccine and the vaccine program
Time frame: 17 months
Vaccine feasibility
Quantitative survey with a structured questionnaire administered to vaccination team members, and in depth interviews of purposefully selected vaccine supervisors and programme managers and focus group discussions with vaccination teams to evaluate the barriers faced in implementing the programme, availability of infrastructural supports, logistics and human resources, the adequacy of the vaccine transportation system, adequacy of cold chain and vaccine storage management, suitability of vaccination session management
Time frame: 17 months
Incidence of cholera among vaccinated individuals in vaccination area
Vaccine induced protective immunity and the indirect protection ( Herd immunity) will be estimated from comparing the incidence of cholera among vaccine recipients in the vaccination area and the incidence of cholera among vaccine non recipients in the same area.
Time frame: Two years after completion of vaccination
Plan to share: No — Individual participant data will not be shared to anybody.
Ran from Jan 2016 to primary completion in Oct 2019, 45 months.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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International Centre for Diarrhoeal Disease Research, Bangladesh →