Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial
Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial
复制标题
DOI：
10.1016/s0140-6736(15)61140-0
复制
发表时间：
2015-10-03
期刊：
影响因子：
168.9
通讯作者：
Clemens, John D.
中科院分区：
文献类型：
--
作者：
Qadri, Firdausi;Ali, Mohammad;Clemens, John D.
背景：霍乱在孟加拉国流行，每年都有流行。是否决定使用廉价的口服灭活全细胞霍乱疫苗来控制疾病，取决于在公共卫生环境下接种疫苗的可行性和有效性。因此，我们评估了在孟加拉国城市通过常规政府服务提供此类疫苗的可行性和保护效果，并评估了在这种情况下增加行为干预以鼓励安全饮用水和洗手接种疫苗的好处。方法我们在孟加拉国达卡进行了这项整群随机开放标签试验。我们随机分配了90个组(1：1：1)，分别只接种疫苗、接种疫苗和改变行为，或者不进行干预。主要结果是总体保护效果，评估为接种第二剂疫苗时在场的所有个人在接种疫苗后2年内严重脱水霍乱的风险。这项研究在ClinicalTrials.gov上注册，编号为NCT01339845。在基线的268 896人中，我们分析了267 270人：94 675人仅分配给接种疫苗，92 539人分配给疫苗接种和行为改变，80056人分配给不干预。仅接种疫苗组的疫苗覆盖率为65%，接种疫苗和行为改变组的疫苗覆盖率为66%。预防接种组的总有效率为37%(95%CI下限为18%；p=0.002)，接种加行为改变组为45%(95%CI下限为24%；p=0.001)。我们没有记录与疫苗相关的严重不良事件。解释说，我们的研究结果首次表明，使用常规的政府服务向患有地方性霍乱的贫困城市人口提供口服灭活全细胞霍乱疫苗的效果，并将帮助政策制定者制定疫苗接种战略，以减轻这些人口中严重脱水的霍乱的负担。
Background Cholera is endemic in Bangladesh with epidemics occurring each year. The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting. We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and hand washing to vaccination in this setting.Methods We did this cluster-randomised open-label trial in Dhaka, Bangladesh. We randomly assigned 90 clusters (1: 1: 1) to vaccination only, vaccination and behavioural change, or no intervention. The primary outcome was overall protective effectiveness, assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose. This study is registered with ClinicalTrials.gov, number NCT01339845.Findings Of 268 896 people present at baseline, we analysed 267 270: 94 675 assigned to vaccination only, 92 539 assigned to vaccination and behavioural change, and 80 056 assigned to non-intervention. Vaccine coverage was 65% in the vaccination only group and 66% in the vaccination and behavioural change group. Overall protective eff ectiveness was 37% (95% CI lower bound 18%; p=0.002) in the vaccination group and 45% (95% CI lower bound 24%; p= 0.001) in the vaccination and behavioural change group. We recorded no vaccine-related serious adverse events.Interpretation Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban populations with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such populations.