Efficacy of a pneumococcal conjugate vaccine against acute otitis media
Efficacy of a pneumococcal conjugate vaccine against acute otitis media
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DOI：
10.1056/nejm200102083440602
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发表时间：
2001-02-08
影响因子：
158.5
通讯作者：
Ecrola, M
中科院分区：
文献类型：
--
作者：
Eskola, J;Kilpi, T;Ecrola, M
背景：耳部感染是生命最初两年的常见疾病。新的结合疫苗可能能够防止相当一部分的情况下，急性中耳炎引起的肺炎链球菌pneumonia.Methods：我们招募了1662名婴儿在一个随机的，双盲的疗效试验的七价肺炎球菌多糖结合疫苗，其中的载体蛋白是无毒的白喉毒素类似物CRM 197。这些儿童在2、4、6和12个月大时接受研究疫苗或作为对照的B肝炎疫苗。急性中耳炎的临床诊断是根据预先确定的标准，细菌学诊断是根据培养中耳液获得鼓膜切开术。肺炎球菌疫苗的局部反应比B型肝炎疫苗多，但比同时接种的全细胞白喉-破伤风-百日咳和B型流感嗜血杆菌联合疫苗少。在6.5至24个月的随访期间，有2596例急性中耳炎发作。该疫苗将任何原因引起的急性中耳炎发作次数减少了6%（95%置信区间，-4%至16%[负数表示发作次数可能增加]），培养证实的肺炎球菌发作率为34%（95%置信区间，21%至45%），疫苗中所含血清型引起的发病次数减少57%（95%置信区间，44%至67%）。与疫苗中的血清型交叉反应的事件数量减少了51%，而由于所有其他血清型的事件数量增加了33%.Conclusions：七价肺炎球菌多糖-CRM 197结合疫苗是安全有效的，在预防急性中耳炎引起的血清型包括在疫苗中。（N Engl J Med 2001;344：403-9.）版权所有（C）2001马萨诸塞州医学会。
Background: Ear infections are a common cause of illness during the first two years of life. New conjugate vaccines may be able to prevent a substantial portion of cases of acute otitis media caused by Streptococcus pneumoniae.Methods: We enrolled 1662 infants in a randomized, double-blind efficacy trial of a heptavalent pneumococcal polysaccharide conjugate vaccine in which the carrier protein is the nontoxic diphtheria-toxin analogue CRM197. The children received either the study vaccine or a hepatitis B vaccine as a control at 2, 4, 6, and 12 months of age. The clinical diagnosis of acute otitis media was based on predefined criteria, and the bacteriologic diagnosis was based on a culture of middle-ear fluid obtained by myringotomy.Results: Of the children who were enrolled, 95.1 percent completed the trial. With the pneumococcal vaccine, there were more local reactions than with the hepatitis B vaccine but fewer than with the combined whole-cell diphtheria-tetanus-pertussis and Haemophilus influenzae type b vaccine that was administered simultaneously. There were 2596 episodes of acute otitis media during the follow-up period between 6.5 and 24 months of age. The vaccine reduced the number of episodes of acute otitis media from any cause by 6 percent (95 percent confidence interval, -4 to 16 percent [the negative number indicates a possible increase in the number of episodes]), culture-confirmed pneumococcal episodes by 34 percent (95 percent confidence interval, 21 to 45 percent), and the number of episodes due to the serotypes contained in the vaccine by 57 percent (95 percent confidence interval, 44 to 67 percent). The number of episodes attributed to serotypes that are cross-reactive with those in the vaccine was reduced by 51 percent, whereas the number of episodes due to all other serotypes increased by 33 percent.Conclusions: The heptavalent pneumococcal polysaccharide-CRM197 conjugate vaccine is safe and efficacious in the prevention of acute otitis media caused by the serotypes included in the vaccine. (N Engl J Med 2001;344:403-9.) Copyright (C) 2001 Massachusetts Medical Society.