AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland.
AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland.
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DOI：
10.1371/journal.pone.0033536
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
Kilpi T
中科院分区：
文献类型：
--
作者：
Nohynek H;Jokinen J;Partinen M;Vaarala O;Kirjavainen T;Sundman J;Himanen SL;Hublin C;Julkunen I;Olsén P;Saarenpää-Heikkilä O;Kilpi T
发作性睡病是一种慢性睡眠障碍，具有很强的遗传易感性，会导致白天过度嗜睡和猝倒。在芬兰观察到，在大流行流感流行和接种AS03佐剂的Pandemrix疫苗后不久，儿童发作性睡病突然增加。在其他年龄组中未观察到增加。回顾性队列研究。从2009年1月1日至2010年12月31日，我们对1991年1月至2005年12月期间出生的所有居住在芬兰的儿童进行了回顾性跟踪调查。所有人群的疫苗接种数据来自初级卫生保健数据库。所有新病例都被指定为发作性睡病的ICD-10编码，并由两名专家审阅病历，以根据Bright ton协作标准对发作性睡病的诊断进行分类。发作性发作性睡病被定义为由于白天过度嗜睡而首次接触医疗保健。主要的随访期被限制在2010年8月15日，也就是媒体开始关注疫苗接种后发作性睡病的前一天。队列中的疫苗接种率为75%。在67例确诊的发作性睡病病例中，46例接种了疫苗，7例未接种，纳入了初步分析。接种疫苗者发作性睡病的发病率为9.0，而未接种者为0.7/10万人年，比率为12.7(95%可信区间6.1-30.8)。接种疫苗的4至19岁儿童患发作性睡病的风险为1：16,000(95%可信区间为1：13,000-1：21,000)。在2009-2010年芬兰流感大流行期间，Pandemrix疫苗导致了4至19岁儿童发作性睡病。需要进一步的研究来确定这种观察是否存在于其他人群中，并阐明潜在的潜在免疫学机制。特别是佐剂的作用需要进一步研究，然后才能得出关于未来使用佐剂大流行疫苗的结论。
Narcolepsy is a chronic sleep disorder with strong genetic predisposition causing excessive daytime sleepiness and cataplexy. A sudden increase in childhood narcolepsy was observed in Finland soon after pandemic influenza epidemic and vaccination with ASO3-adjuvanted Pandemrix. No increase was observed in other age groups. Retrospective cohort study. From January 1, 2009 to December 31, 2010 we retrospectively followed the cohort of all children living in Finland and born from January 1991 through December 2005. Vaccination data of the whole population was obtained from primary health care databases. All new cases with assigned ICD-10 code of narcolepsy were identified and the medical records reviewed by two experts to classify the diagnosis of narcolepsy according to the Brighton collaboration criteria. Onset of narcolepsy was defined as the first documented contact to health care because of excessive daytime sleepiness. The primary follow-up period was restricted to August 15, 2010, the day before media attention on post-vaccination narcolepsy started. Vaccination coverage in the cohort was 75%. Of the 67 confirmed cases of narcolepsy, 46 vaccinated and 7 unvaccinated were included in the primary analysis. The incidence of narcolepsy was 9.0 in the vaccinated as compared to 0.7/100,000 person years in the unvaccinated individuals, the rate ratio being 12.7 (95% confidence interval 6.1–30.8). The vaccine-attributable risk of developing narcolepsy was 1∶16,000 vaccinated 4 to 19-year-olds (95% confidence interval 1∶13,000–1∶21,000). Pandemrix vaccine contributed to the onset of narcolepsy among those 4 to 19 years old during the pandemic influenza in 2009–2010 in Finland. Further studies are needed to determine whether this observation exists in other populations and to elucidate potential underlying immunological mechanism. The role of the adjuvant in particular warrants further research before drawing conclusions about the use of adjuvanted pandemic vaccines in the future.
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