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临床试验/NCT02727855
NCT02727855已完成不适用

Targeted Vaccination of Children in Urban Slums Against Cholera: Evaluation of a Potentially Cost-effective and Impactful Strategy for Deploying Oral Cholera Vaccine in Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 75,170 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75,170
试验地点
1
主要终点
Number of participants with two doses of oral cholera vaccine (Shanchol) will get protection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All healthy, consenting, non-pregnant (as ascertained by history) residents of a high risk group, 1 to 14 years of age, of the study area will be included in the study.

排除标准

  • Aged less than 1 year and more than 14 years
  • History of intake of any cholera vaccine
  • Pregnant women (identified through verbal screening)

结局指标

主要结局

Number of participants with two doses of oral cholera vaccine (Shanchol) will get protection

时间窗: 2 years from dosing

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.

次要结局

  • Cholera vaccine coverage(10 months)
  • Vaccine acceptability(17 months)
  • Vaccine feasibility(17 months)
  • Incidence of cholera among vaccinated individuals in vaccination area(Two years after completion of vaccination)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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