Effectiveness of an oral cholera vaccine campaign to prevent clinically-significant cholera in Odisha State, India
Effectiveness of an oral cholera vaccine campaign to prevent clinically-significant cholera in Odisha State, India
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DOI：
10.1016/j.vaccine.2015.03.073
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发表时间：
2015-05-15
期刊：
影响因子：
5.5
通讯作者：
Sah, Binod
中科院分区：
文献类型：
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作者：
Wierzba, Thomas F.;Kar, Shantanu K.;Sah, Binod
背景资料：在印度进行的一项临床试验表明，口服霍乱疫苗Shanchol在五年内可提供65%的保护，防止临床上严重的霍乱。虽然该疫苗在实验环境中测试时是有效的，但政策制定者更有可能在获得证据证明使用当地卫生部门工作人员、冷链设备和物流将疫苗运送到社区时提供保护后使用该疫苗。我们用的是阴性的个案─对照设计，以评估使用Shanchol的疫苗接种活动的有效性，并使用队列方法验证结果，寻求医疗保健行为的差异。这项运动是由当地卫生部门利用印度奥里萨邦普里区霍乱流行地区的现有资源开展的。所有一岁以上的非怀孕居民都接种了疫苗。在接下来的两年里，在五个卫生机构之一寻求腹泻护理的居民被要求在知情同意后登记。病例是因实验室确诊的霍乱弧菌相关腹泻寻求治疗的患者。结果：在51，488名符合条件的居民中，31，552人接受了一剂疫苗，23，751人接受了两剂疫苗。我们确定了44例霍乱弧菌相关病例和366例非霍乱弧菌腹泻对照。接受两次剂量的受试者的调整后保护有效性为69.0%（95% CI：14.5%至88.8%），这与从队列方法获得的调整后估计值相似。统计趋势检验表明，单剂量提供了少量的保护（33%，测试的趋势，p = 0.0091）。结论：这种疫苗被认为是有效的，从临床试验报告的结果，当管理到农村人口使用当地的卫生人员和资源。这项研究提供的证据表明，这种疫苗应该在霍乱流行地区的公共卫生部门广泛部署。(C)2015作者由爱思唯尔有限公司出版。这是一篇在CC BY-NC-ND许可证下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/4.0/）。
Background: A clinical trial conducted in India suggests that the oral cholera vaccine, Shanchol, provides 65% protection over five years against clinically-significant cholera. Although the vaccine is efficacious when tested in an experimental setting, policymakers are more likely to use this vaccine after receiving evidence demonstrating protection when delivered to communities using local health department staff, cold chain equipment, and logistics.Methods: We used a test-negative, case-control design to evaluate the effectiveness of a vaccination campaign using Shanchol and validated the results using a cohort approach that addressed disparities in healthcare seeking behavior. The campaign was conducted by the local health department using existing resources in a cholera-endemic area of Puri District, Odisha State, India. All non-pregnant residents one year of age and older were offered vaccine. Over the next two years, residents seeking care for diarrhea at one of five health facilities were asked to enroll following informed consent. Cases were patients seeking treatment for laboratory-confirmed V. cholera-associated diarrhea. Controls were patients seeking treatment for V. cholerae negative diarrhea.Results: Of 51,488 eligible residents, 31,552 individuals received one dose and 23,751 residents received two vaccine doses. We identified 44 V. cholerae O1-associated cases and 366 non V. cholerae diarrhea controls. The adjusted protective effectiveness for persons receiving two doses was 69.0% (95% CI: 14.5% to 88.8%), which is similar to the adjusted estimates obtained from the cohort approach. A statistical trend test suggested a single dose provided a modicum of protection (33%, test for trend, p =0.0091).Conclusion: This vaccine was found to be as efficacious as the results reported from a clinical trial when administered to a rural population using local health personnel and resources. This study provides evidence that this vaccine should be widely deployed by public health departments in cholera endemic areas. (C) 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).