Effectiveness of an Adjuvanted Monovalent Vaccine Against the 2009 Pandemic Strain of Influenza A(H1N1)v, in Stockholm County, Sweden

Effectiveness of an Adjuvanted Monovalent Vaccine Against the 2009 Pandemic Strain of Influenza A(H1N1)v, in Stockholm County, Sweden
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DOI:
10.1093/cid/cir182
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发表时间:
2011-05-15
影响因子:
11.8
通讯作者:
Svenungsson, Bo
Svenungsson, Bo
中科院分区:
医学1区
文献类型:
--
作者:
Ortqvist, Ake;Berggren, Ingela;Svenungsson, Bo

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背景2009年期间,许多国家进行了甲型H1N1流感疫苗接种,但缺乏基于人口的疫苗有效性数据。我们进行了一项前瞻性队列研究,研究对象为2009年10月12日至12月31日期间接受单价AS 03佐剂甲型H1N1流感病毒疫苗(Pandemrix,GSK)接种的斯德哥尔摩县所有居民(n = 2,019,183)。总的疫苗接种率为52%。一个基于网络的登记册上有所有接种疫苗的数据,通过唯一的个人识别号码与甲型H1N1流感病毒诊断的强制性报告联系在一起。疫苗失败定义为疫苗接种后> 14天诊断为流感或因流感住院。在巢式病例对照研究中,采用条件逐步Logistic回归分析与疫苗接种失败相关的危险因素。计算疫苗接种者与未接种者诊断为流感的周发病率比。在2594例确诊为甲型H1N1流感的患者中,25例患者(11例儿童和14例成人)出现疫苗失败。与年龄匹配的对照组相比,疫苗失败的患者更常出现免疫功能低下(风险比,4.89; 95%置信区间[CI],2.19-10.89)。在流感活动最大的4周内,接种疫苗人群中甲型H1N1流感病毒诊断的每周相对风险为0.06(95%CI.008-.41)、.13(95%CI.06-.27)、.05(95%CI.02-.12)和.07(95%CI.03-.15),对应于87- 95%的每周疫苗有效性。在斯德哥尔摩县,单价AS 03佐剂流感疫苗在预防大流行性流感方面非常有效。除了免疫功能低下的宿主外,对大多数人(包括儿童和成人)来说,单剂量似乎就足够了。
Background. Vaccination against the pandemic influenza A(H1N1)v was performed in many countries during 2009, but population-based data on vaccine effectiveness are lacking.Methods. We conducted a prospective cohort study involving all inhabitants in Stockholm County (n = 2,019,183) who were offered a monovalent AS03-adjuvanted influenza A(H1N1)v vaccine (Pandemrix, GSK), between 12 October and 31 December 2009. Overall vaccine coverage was 52%. A Web-based register with data on all vaccinated was linked by unique personal identification number tomandatory reports of influenza A(H1N1)v diagnoses. Vaccine failure was defined as a diagnosis or admission to hospital because of influenza > 14 days after vaccination. Risk factors associated with vaccine failure were investigated by conditional stepwise logistic regression in a nested case-control study. The weekly incidence rate ratio for being diagnosed with influenza among vaccinated versus nonvaccinated persons was calculated.Results. Vaccine failure was seen in 25 patients, 11 children and 14 adults, of 2594 patients diagnosed with influenza A(H1N1)v. Compared with age-matched controls, patients with vaccine failure were more often immunocompromised (Hazard Ratio, 4.89; 95% confidence interval [CI], 2.19-10.89). During the 4 weeks with maximum influenza activity, the relative risk per week for an influenza A(H1N1)v diagnosis in the vaccinated population was .06 (95% CI .008-.41), .13 (95% CI .06-.27), .05 (95% CI .02-.12), and .07 (95% CI .03-.15), respectively, corresponding to a weekly vaccine effectiveness of 87-95%.Conclusions. The monovalent AS03-adjuvanted influenza vaccine was highly effective in prevention of the pandemic influenza in Stockholm County. A single dose seemed to be sufficient in most, both children and adults, except in immunocompromised hosts.