A Cluster-Randomized Effectiveness Trial of Vi Typhoid Vaccine in India
A Cluster-Randomized Effectiveness Trial of Vi Typhoid Vaccine in India
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DOI：
10.1056/nejmoa0807521
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发表时间：
2009-07-23
影响因子：
158.5
通讯作者：
Clemens, John D.
中科院分区：
文献类型：
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作者：
Sur, Dipika;Ochiai, R. Leon;Clemens, John D.
背景伤寒仍然是发展中国家疾病和死亡的重要原因。对Vi多糖疫苗在5岁以下儿童中的保护作用以及疫苗在规划条件下的作用的了解已经抑制了其在发展中国家的使用。MethodsWe进行了第4阶段有效性试验，其中印度加尔各答的贫民窟居民，2岁或2岁以上的人根据地理集群随机分配接受单剂Vi疫苗或灭活甲型肝炎疫苗，每个研究组有40个集群。受试者随后进行了2 years.ResultsA共37,673名受试者接受了一剂研究疫苗。Vi疫苗组的平均疫苗覆盖率为61%，甲型肝炎疫苗组的平均疫苗覆盖率为60%。甲型肝炎疫苗组中有96名受试者被诊断为伤寒，而Vi疫苗组中有34名，没有受试者有一次以上的发作。Vi疫苗的保护有效性水平为61%（95%置信区间[CI]，41 - 75; P
BackgroundTyphoid fever remains an important cause of illness and death in the developing world. Uncertainties about the protective effect of Vi polysaccharide vaccine in children under the age of 5 years and about the vaccine's effect under programmatic conditions have inhibited its use in developing countries.MethodsWe conducted a phase 4 effectiveness trial in which slum-dwelling residents of Kolkata, India, who were 2 years of age or older were randomly assigned to receive a single dose of either Vi vaccine or inactivated hepatitis A vaccine, according to geographic clusters, with 40 clusters in each study group. The subjects were then followed for 2 years.ResultsA total of 37,673 subjects received a dose of a study vaccine. The mean rate of vaccine coverage was 61% for the Vi vaccine clusters and 60% for the hepatitis A vaccine clusters. Typhoid fever was diagnosed in 96 subjects in the hepatitis A vaccine group, as compared with 34 in the Vi vaccine group, with no subject having more than one episode. The level of protective effectiveness for the Vi vaccine was 61% (95% confidence interval [CI], 41 to 75; P