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临床试验/NCT01339845
NCT01339845已完成不适用

Introduction of Cholera Vaccine in Bangladesh: " Impact Evaluation of Cholera Vaccine and Behaviour Change Interventions in Urban Dhaka"

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 240,000 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240,000
试验地点
2
主要终点
Number of individuals vaccinated with two dose of oral cholera vaccine.

研究概览

简要总结

The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high incidence urban area. This study will also evaluate the feasibility of adding a household hand washing and safe drinking water promotion intervention to a cholera vaccine program and the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio cholerae.

详细描述

Cholera continues to be a major cause of morbidity and mortality in low income countries including Bangladesh. It is estimated that there are at least 300,000 severe cases and 1.2 million infections in people in Bangladesh each year. Deaths annually from cholera may have decreased but overall morbidity remains high.

The project for "Introduction of Cholera Vaccine in Bangladesh" (ICVB) will examine the effectiveness of intervention with an oral cholera vaccine in reducing incidence of cholera in urban Dhaka, and the effectiveness of a handwashing and home water treatment behaviour change intervention in reducing diarrhea due to cholera. The proposal involves evaluation of a 2-dose regimen of an oral killed whole cell (WC) vaccine and a handwashing and home water treatment behavior change program promoting improved hygiene and home drinking water treatment in reducing dehydrating diarrhea in a low income area of Dhaka, Bangladesh. The study population will include 90 clusters (neighborhoods) in an area of high cholera incidence in Mirpur with a total study population of 240,000. Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone, 30 clusters will receive both cholera vaccine and behavior change and 30 neighborhoods will continue their standard habits and practices. Surveillance for cholera and diarrhea will be carried out in all the three areas during the whole project period. Following the GIS mapping and census of the target populations, the cholera vaccine will be offered to all males and non-pregnant females aged one year and above in the vaccination areas, and an aggressive hygiene and safe water promotion program will be implemented in the 30 behavior change communication clusters. Passive surveillance for cholera will be undertaken using the two ICDDR,B diarrhea treatment facilities as well as 10 other health facilities that serve the study areas. Vaccine and other public health coverage and costs effectiveness as well cost-benefit will be measured, followed by surveillance and identical follow-up studies. The hygiene and safe water behavior change program will also be continued for 4 years. The impact of interventions will be assessed by following vaccination by directly comparing the incidence of cholera and diarrhea in the intervention communities to the incidence in the standard habits and practices communities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy residents of selected vaccination sites
  • Aged 1 year and above
  • Non-pregnant women
  • Written informed consent

排除标准

  • Age less than 1 year
  • Pregnant women

结局指标

主要结局

Number of individuals vaccinated with two dose of oral cholera vaccine.

时间窗: Six months from initiation of vaccination

Tergated individuals will be vaccinated and vaccination records will give the coverage.

Decrease number of cholera cases in intervention arm compared to non-intervention arm.

时间窗: Two years after completion of vaccination

The primary analyses will be comparison of the incidence of primary outcome in the intervention clusters compared to the non-intervention cluster

次要结局

  • Incidence of cholera among vaccinated individuals in vaccination area.(Two years after completion of vaccination.)
  • Incidence of cholera among non-vaccinated individuals in vaccination area.(Two years after completion of vaccination)
  • Incidence of cholera in the combined cholera vaccine and behavior change intervention area(Two years after completion of vaccination)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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