Safety and efficacy of the seven-valent pneumococcal conjugate vaccine: evidence from Northern California
Safety and efficacy of the seven-valent pneumococcal conjugate vaccine: evidence from Northern California
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DOI：
10.1007/s00431-002-1064-z
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发表时间：
2002-12-01
影响因子：
3.6
通讯作者：
Shinefield, H
中科院分区：
文献类型：
--
作者：
Black, S;Shinefield, H
肺炎球菌疾病仍然是幼儿发病的一个重要原因。在北方加州Kaiser Permanente系统进行的一项大规模有效性试验（KP试验）证明，七价结合疫苗（PCV）在幼儿中是安全和免疫原性的，可有效预防疫苗血清型引起的侵袭性肺炎球菌疾病（97.4%的有效性）和中耳炎发作（7.0%的有效性）。自2000年KP试验结果发表以来，我们对疫苗在低出生体重（LBW）和早产（PT）婴儿中的安全性、免疫原性和有效性进行了额外分析，并在许可后1年的大规模使用期间检查了疫苗的有效性。该疫苗在LBW和PT婴儿中的免疫原性至少与在正常体重的足月婴儿中的免疫原性相同，并且100%有效，尽管LBW和PT婴儿的不良事件（如发红和肿胀）发生率较高。接种肺炎球菌疫苗的LBW和PT婴儿也比接种对照脑膜炎球菌疫苗的婴儿有更高的不良事件发生率，如荨麻疹，但这些反应并不严重。当PCV用于一般人群时，效力仍然很高，并且由非疫苗血清型引起的疾病没有相应增加。也有证据表明，接种疫苗导致群体免疫。发热性疾病是接种疫苗后比对照期更常见的唯一不良事件。结论：七价结合疫苗在一般人群中使用是安全有效的。
Pneumococcal disease remains a significant cause of morbidity among young children. A large-scale efficacy trial in the Northern California Kaiser Permanente system (the KP trial) demonstrated that a seven-valent conjugate vaccine (PCV) is safe and immunogenic in young children and effective in preventing both invasive pneumococcal disease caused by vaccine serotypes (97.4% efficacy) and episodes of otitis media (7.0% efficacy). Since the publication of the results of the KP trial in 2000, we have performed an additional analysis on the safety, immunogenicity, and efficacy of the vaccine in low birth weight (LBW) and preterm (PT) infants, and have examined the efficacy of the vaccine during I year of wide-scale post-licensure use. The vaccine was at least as immunogenic in LBW and PT infants as in normal-weight, full-term infants and was 100% effective, although the LBW and PT infants had higher rates of adverse events such as redness and swelling. LBW and PT infants receiving pneumococcal vaccine also had higher rates of adverse events, such as hives, than those receiving control meningococcal vaccine, but these reactions were not severe. When the PCV was used in the general population, the efficacy remained high and there was no corresponding increase in disease caused by nonvaccine serotypes. There was also evidence that vaccine administration led to herd immunity. Febrile illness was the only adverse event seen more frequently after vaccine administration than during a control period. Conclusion: the seven-valent conjugate vaccine is safe and effective for use in the general population.