中小学师生接种甲型H1N1流感疫苗的安全性观察

目的评价甲型H1N1流感疫苗上市后大规模应用的安全性。方法选取符合条件的中小学学校,为符合入选标准并自愿接种疫苗的师生随机接种甲型H1N1流感疫苗或季节性流感疫苗,采用主动监测和被动报告的方法观察接种后一般反应和异常反应的发生情况。结果接种甲型H1N1流感疫苗一般反应发生率为4.00%(68/1 702),接种季节性流感疫苗发生率为4.86%(81/1 665);接种甲型H1N1流感疫苗异常反应发生率为0.94%(16/1 702),接种季节性流感疫苗发生率为1.14%(19/1 665);异常反应病例均为过敏性皮疹,未发生严重异常反应。结论国产15μg裂解无佐剂甲型H1N1流感疫苗不良反应发生率与季节性流感疫苗相当,说明其安全性可靠。     

甲型H1N1流感疫苗安全性评述

2009年甲型H1N1流感疫情在全球范围内快速蔓延,严重威胁人类健康和生命,影响社会经济稳定。世卫组织公布的数据显示,截至2009年10月25日,全球有44万多例经实验室确认的甲型H1N1流感病例,至少5712A死亡。据美国官方统计甲型H1N1流感已造成1000多名美国人死亡,现有的住院甲型H1N1流感患者很可能已超过2万人。据我国官方统计截至2009年11月4日,我国内地累计报告5．1万余例甲型H1N1流感确诊病例,重症病例累计153例,死亡8例。目前全球已拉响了甲型H1N1流感警报。因此,采取有效的防控措施预防甲型H1N1流感的爆发是目前迫在眉睫解决的问题。     

甲型H1N1流感病毒裂解疫苗接种的安全性观察

目的了解甲型H1N1流感病毒裂解疫苗接种的安全性,为在临床推广使用提供依据。方法按照疫苗生产单位及上级卫生行政部门的要求,对我院职工567人进行甲型H1N1流感病毒裂解疫苗接种,所有接种者均符合接种条件,并填写知情同意书。观察所有接种者的局部表现和全身表现。结果接种甲型H1N1流感病毒裂解疫苗不良反应发生率低,局部、全身反应均轻微。结论大规模接种此疫苗是安全的。     

接种甲型H1N1流感疫苗后患甲型H1N1流感分析

目的 分析接种甲型H1N1流感疫苗后发生甲型H1N1流感感染的病例,探讨发病原因,为进一步提高疫苗预防效果提供参考依据.方法 对接种甲型H1N1流感疫苗后发生甲型H1N1流感感染148例,进行回顾性调查分析.结果 接种甲型H1N1流感疫苗11176例.发生甲型H1N1感染148例,感染率1.32%,其中1～14 d感染81例,感染率0.72%,＞15 d感染67例,感染率0.60%.结论 甲型H1N1流感病毒裂解疫苗是一种安全高效的疫苗,不足之处尚待进一步探讨、完善.     

甲型H1N1流行性感冒病毒裂解疫苗的安全性研究

目的评价甲型H1N1流行性感冒裂解疫苗(简称甲流疫苗)的安全性。方法设立主动监测点,通过全国疑似预防接种异常反应信息管理系统,收集全市接种甲流疫苗和主动监测点接种季节性流感疫苗后的AEFI个案信息,采用描述性方法对相关指标进行流行病学分析。结果邯郸市常规报告接种甲流疫苗后AEFI发生率14.64/10万,以一般反应为主,占88.57%,症状主要为38.5℃以下的低热,无严重不良反应和接种事故发生。主动监测点接种甲流疫苗后AEFI发生率752.63/10万,全部为一般反应,以发热为主。主动监测点接种季节性流感疫苗后AEFI发生率203.14/10万,全部为一般反应,均为发热。结论甲流疫苗接种后AEFI发生率高于季节性流感疫苗,但低于欧盟流感疫苗评价指标。甲流疫苗接种后AEFI反应类型以一般反应为主,且多为低热。甲流疫苗是安全的。     

2009年成都市甲型H1N1流感疫苗免疫效果评价

目的评估成都市2009年甲型H1N1流感疫苗的免疫效果。方法在6个监测点选择3～11岁、12～17岁学生,18～60岁、〉60岁社区居民,用微量血凝抑制试验方法测定甲流抗体。结果监测对象H I抗体阳转率为71.46%,H I抗体达保护性水平比例为75.86%,免后GMT为72.32,GMT增长倍数为23.78倍。3～11岁、〉60岁组H I抗体阳转分别为59.52%、58.06%;H I抗体达保护性水平比例为64.29%、60.54%;免后GMT分别为39.66、42.07;GMT增长倍数分别为10.99、25.24倍。结论各年龄组疫苗免疫效果存在差异。3～11岁、〉60岁组免疫效果较其他2组差。     

接种甲型H1N1流感疫苗1年后免疫持久性评价

目的 评价成都市甲型H1N1流感疫苗接种1年后疫苗免疫持久性.方法 以2010年免后1个月HI抗体≥1∶40的398人作为观察对象,用微量血凝抑制试验方法测定抗体,计算人群抗体几何平均滴度(GMT)和疫苗保护率.结果 免疫后1年人群GMT下降62.03％,抗体保护率达92.71％,老年组保护率为83.12％;免后1个月低抗体水平个体(1∶40、1∶80),1年后有40.21％的人抗体滴度上升.结论 甲流疫苗具有一定的免疫持久性,老人免疫持久性相对较差.     

接种甲型H1N1流感疫苗后副反应分析

目的分析人群接种甲型H1N1流感病毒裂解疫苗(甲流疫苗)后副反应生情况,了解其安全性。方法对接种甲流疫苗后人群进行常规副反应监测,并对出现疑似预防接种异常反应者进行个案调查,利用EXCEL2003及描述性方法对数据进行整理分析。结果全市共接种368538人,报告副反应63例,报告发生率为17.09/10万,其中比例高的前3位是高热21例(33.33%)、群发性癔症16例(25.40%)、神经系统过敏反应7例(11.11%),发生率分别为5.7/10万、4.34/10万、1.90/10万;职业发生率前3位是医务人员(37.69/10万)、工人(36.68/10万)、农民(36.18/10万);男女性别比为2.15∶1(43/20),平均年龄19.81岁,平均发生时间6.3hr。结论甲流疫苗副反应发生率低,以发热和疫苗过敏性反应为主。     

无锡市甲型H1N1流感及季节性流感疫苗接种效果分析

目的调查流感样病例(ILI)和无锡市一般人群中甲型H1N1流感疫苗及季节性流感疫苗的接种情况,评估疫苗接种后对人群的保护效果。方法以无锡市2家哨点医院为基础,采集流感样病例病毒核酸检测阳性的病例作为病例组,共1 529人,同时按照"病例"的电话信息,随机产生电话号码选择、年龄匹配的一般人群作为对照组,共380人。结果病例组甲型H1N1流感疫苗接种率为6.1%(94/1 529),对照组甲型H1N1流感疫苗接种率为12.1%(46/380),两组比较,差异有统计学意义(P0.01);甲型H1N1流感病例中接种甲型H1N1流感疫苗的比例为12.5%(3/24),门诊检测阴性的ILI病例接种甲型H1N1流感疫苗的比例为6.1%(78/1 273),"接种甲型H1N1流感疫苗"因素的OR值为0.457(P=0.201);以电话调查一般人群(330例)作为对照组,接种甲型H1N1流感疫苗的比例为13.3%(44/330),OR值为1.077(P=0.908)。结论该次调查说明接种甲型H1N1流感疫苗对预防流感样病例有一定效果,但由于样本量较少,24种方法病例对照分析均未得出差异有统计学意义。     

甲型H1N1流感疫苗预防接种效果观察

目的探讨接种甲型H1N1流感疫苗的有效性和安全性。方法选择120例18～60岁在我院接种甲型H1N1流感疫苗人员为接种组,同时按照年龄、性别、疾病匹配的情况选取未接种甲型H1N1流感疫苗者110例为对照组。调查分析甲型H1N1流感疫苗接种后90d内两组甲型H1N1流感发病率和其他流感样疾病发生情况。同时观察接种甲型H1N1流感疫苗后48h内不良反应发生情况。结果接种组甲型H1N1流感发病率和就诊率为0%,对照组甲型H1N1流感发病率和就诊率为7.3%,两组比较有显著统计学差异（P〈0.01）;接种组90d内甲型H1N1流感的保护率为100%,减少就诊率100%。接种组其他流感样疾病发生率（15.0%）和就诊率（8.3%）均明显低于对照组（22.7%和16.3%）,有统计学差异（P〈0.05）;接种组90d内其他流感样疾病的保护率为33.9%,减少就诊率49.4%;接种组共出现不良反应8例,总体不良反应率6.7%,给予适当的处理,症状很快消失。结论接种甲型H1N1流感疫苗是有效和安全的。     

Safety and immunogenicity of a 2009 influenza A (H1N1) vaccine in hemodialysis patients

A worldwide vaccination campaign against the 2009 pandemic influenza A (H1N1) virus was launched among high-risk subjects, including hemodialysis patients. The long-term immunogenicity of an influenza vaccine has not been investigated in hemodialysis patients. This study aimed to (1) assess the long-term immunogenicity of a monovalent non-adjuvanted influenza A (H1N1) vaccine in hemodialysis patients and (2) determine the safety of this vaccine. We conducted a prospective cohort study of 44 hemodialysis patients and 149 healthy controls in 2010. All of the participants received a single dose of the monovalent non-adjuvanted 2009 influenza A (H1N1) vaccine. The level of antibodies was measured at baseline and at 4 and 24 weeks post-vaccination using a hemagglutination inhibition assay. The outcomes were the percentages of participants who achieved seroconversion and seroprotection (titer ≥1:40) 4 and 24 weeks after vaccination. At 4 weeks post-vaccination, seroconversion was observed in 17 (38.6%) of the hemodialysis patients and 94 (63.1%) of the controls (P = 0.056), and protective titers were obtained in 22 (50%) of the hemodialysis patients and 100 (67.1%) of the controls (P = 0.426). At 24 weeks post-vaccination, immunogenicity decreased in both the hemodialysis patients and the controls, but there were no significant differences between the hemodialysis patients and the controls in the seroconversion rate (27.3% versus 36.9%, P = 0.526) or the seroprotection rate (38.6% versus 48.3%, P = 0.996). No differences in adverse events were observed between the hemodialysis patients and the controls. In summary, the 2009 influenza A (H1N1) vaccine elicits a similar immune response in both hemodialysis patients and healthy controls, but immunity declines 24 weeks after vaccination in both groups. Hemodialysis patients should at least be vaccinated annually against the influenza virus.     

The immunogenicity of a novel A (H1N1) vaccine in HIV-infected children

Background

In October 2009, the United Kingdom Department of Health recommended vaccination of high-risk groups, including children with HIV, with a novel, oil-in-water AS03_B adjuvanted Influenza A (H1N1) vaccine (Pandemrix™). There were no published data available regarding the immunogenicity of this vaccine in such children.

Objectives

This study evaluated the immunogenicity of the adjuvanted Influenza A (H1N1) vaccine in HIV-infected children immunised according to national recommendations and assessed the impact of vaccination on individual CD4 counts and HIV viral loads.

Methods

HIV-infected children attending outpatient appointments between 01 November and 31 December 2009 were offered two doses of H1N1 vaccine three weeks apart and a blood test before and 3 weeks after the second dose of vaccine. Serum antibody responses were determined by a haemagglutination inhibition (HAI) assay using standard methods.

Results

Of the 39 children recruited for vaccination, 31 (median age 11.2, range 3.0-17.9 years) received both doses of vaccine and provided pre- and post-vaccination blood samples. Eight children (26%) had baseline HAI titres ≥1:32. After vaccination, 29 children (94%, 95% CI, 78.6-99.2%) had HAI titres ≥1:32 (seroprotection), of whom 27 (87.1%, 95% CI, 70.1-96.4%) had also had a four-fold rise in titres (seroconversion). In the univariate analysis, post-vaccination geometric mean titres (GMTs) were higher among the 21 children receiving highly active anti-retroviral therapy compared with the 10 treatment-naïve children (GMT 406 [95% CI 218-757] vs. 128 [49-336]; P = 0.035), but this was no longer statistically significant when adjusted for prevaccine GMTs. There was no significant impact of vaccination on CD4+ T cell count or HIV viral load.

Conclusion

The AS03_B-adjuvanted pandemic Influenza A (H1N1) vaccine is highly immunogenic and appears to be safe in HIV-infected children.     

国产流感裂解疫苗接种人体后安全性和免疫原性评价

目的:评价变更后流感毒株生产的国产流感裂解疫苗安全性和免疫原性。方法:对宁波市宁海县559例分组接种流感裂解疫苗者进行临床指标(局部反应、全身反应)的监测,并抽取其中213例,用流感病毒HI抗体测定法对接种者免疫前后的抗体滴度进行测定,比较免疫前后抗体阳转率及几何平均滴度(GMT)。结果:观察对象接种疫苗后发热反应发生率为1.22%,全身其他反应发生率为1.22%,局部反应发生率为1.07%,且以轻度反应为主。H1N1型、H3N2型、B型免后抗体阳转率分别为84.04%、85.45%、83.57%;不同年龄组免后抗体滴度的增长倍数,H1N1型在5.50～16.00倍之间,H3N2型在13.16～39.33倍之间,B型在7.28～24.85倍之间,各年龄组各抗体型别免疫前后GMT差别均有统计学意义。结论:国产流感裂解疫苗具有良好的安全性和免疫原性。     

甲型H1N1流感疫苗接种对其暴发疫情的影响

目的了解甲型H1N1流感(甲流)疫苗接种后对甲流暴发疫情的影响。方法对2011年4—5月发生在学校的1起甲流暴发疫情进行流行病学描述性分析,用回顾性队列研究的方法分析甲流疫苗接种对该起暴发疫情的影响。结果该校542名师生中191人患病,罹患率为35.24%,发病时间主要集中在4月19—25日,发病人群主要为1～6年级的小学生(χ2=9.972,P0.01),住校生发病高于非住校生,112名接种过甲流疫苗的师生发病率为16.96%,明显低于未接种疫苗的师生(40%),差异有统计学意义(χ2=20.661,P0.05),OR=0.306(95%CI∶0.180～0.521)。结论接种甲流疫苗可以有效预防甲型H1N1流感的发生,减少暴发疫情的发病率。     

Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring

Background

When adjuvant vaccines against the pandemic influenza A (H1N1) virus became available after an accelerated registration process, safety issues dominated the public debate. As part of the immunisation campaign, the Dutch government installed an active monitoring of possible adverse events following immunisation (AEFIs). As part of the monitoring we conducted an anonymous prospective cohort study to identify and quantify the occurrence of AEFIs related to pandemic vaccination among the population immunised in general practice.

Method

Adults aged 60 years and older or persons with a risk-elevating medical condition recommended for vaccination in general practice were eligible for participation. After receipt of the first pandemic vaccine the administrator handed over an information flyer of the web-based monitoring program. The patient could sign up for study participation online. Within one week, three weeks and three months after the first immunisation questions were asked about demographics and health, immunisations, injections site reactions and labeled reactions as well as other possible new AEFIs.

Results

In all, 3569 participants filled in the first questionnaire. Corresponding figures for the second and third questionnaires were 3395 (95.1%) and 3162 (88.6%). Mean age was 58 years (SD 15) and 50.1% was female. Main indication was 60 years or older followed by presence of pulmonary or cardiovascular disease. Of all participants, 1311 (37%) reported an AEFI. Unexpected serious reactions were not reported nor were there signals of possible new AEFIs. The occurrence of an AEFI was determined by gender, age and type of co-morbidity.

Conclusion

The web-based intensive monitoring system among patients immunised in general practice revealed AEFIs due to pandemic vaccination in one-third of participants. There were no unexpected serious adverse events in this population. This advanced methodology can be further developed to monitor real-time use and AEFIs of vaccines.     

Key points in evaluating immunogenicity of pandemic influenza vaccines: A lesson from immunogenicity studies of influenza A(H1N1)pdm09 vaccine

IntroductionImmunogenicity studies on pandemic influenza vaccine are necessary to inform rapid development and implementation of a vaccine during a pandemic. Thus, strategies for immunogenicity assessment are required.ObjectiveTo identify essential factors to consider when evaluating the immunogenicity of pandemic influenza vaccines using the experience in Japan with the influenza A(H1N1)pdm09 vaccine.MethodsWe conducted a search of observational studies using PubMed and IchushiWeb. Search terms included “influenza vaccine AND (immunogenicity OR immune response) AND Japan AND (2009 OR pdm09) NOT review,” and was limited to studies conducted in humans.ResultsA total of 33 articles were identified, of which 16 articles met the inclusion criteria. Immunogenicity of the commercially available influenza A(H1N1)pdm09 vaccine satisfied the international criteria for influenza vaccine immunogenicity in all study populations. The most remarkable immune response was observed in junior high school students, while the lowest immune response was observed in hematological malignancy patients. Similar to immunogenicity studies on seasonal influenza vaccines, factors such as patient background (e.g., age, underlying condition, pre-vaccination titer, body mass index, etc.) and study procedure (e.g., concurrent measurement of pre- and post-vaccination antibody titer, effects of infection during the study period) may have affected the assessment of immunogenicity to the influenza A(H1N1)pdm09 vaccine. In addition, prior vaccination with the seasonal influenza vaccine may inhibit antibody induction by the influenza A(H1N1)pdm09 vaccine.ConclusionsThis review discusses factors and strategies that must be considered and addressed during immunogenicity assessments of pandemic influenza vaccines, which may provide useful information for future influenza pandemics.     

国产甲型H1N1流行性感冒疫苗接种后免疫持久性分析

目的探讨国产甲型H1N1流行性感冒裂解疫苗（简称甲流疫苗）接种后的免疫持久性。方法采用多阶段随机抽样方法,抽取3～5岁、6～10岁、11～15岁、16～20岁、21～40岁、41～60岁和〉60岁7个年龄组共350人作为监测对象。使用微量血凝抑制（haemagglutination inhibition,HI）实验测定监测对象接种甲流疫苗前、接种后28 d和6个月甲流抗体水平。结果接种甲流疫苗后6个月的HI抗体平均滴度、阳转率和保护率均低于接种后28 d;3～5岁和〉60岁两个年龄组接种后28 d抗体几何平均滴度高于接种后6个月（均有P〈0.05）;3～5岁、6～10岁和11～15岁3个年龄组接种后28 d和6个月HI抗体阳转率差异均有统计学意义（均有P〈0.05）。结论国产甲流疫苗能产生较好的免疫应答,并有一定的免疫持久性。     

国产甲型H1NI流感病毒裂解疫苗预防接种不良反应观察

目的了解公众对甲型H1NI流感病毒裂解疫苗的接受程度及预防接种后的临床异常表现。方法统计甲型H1NI流感病毒裂解疫苗的接种率及接种后24h内所出现的异常反应。结果共有13600人自愿按程序要求实施预防接种,占应接种人数的90.67%,共观察到126例临床不良反应(30min内出现的有110例、24h内出现的有16例),占接种人群的0.93%,其中孕妇有2例,占不良反应人群的1.59%,临床表现为头痛、头晕、腹痛、四肢关节痛、瘙痒、发热、疲劳乏力、胸闷、呼吸困难。所有反应均在24h内消失。结论甲型H1NI流感疫苗产品质量是安全的、可控制的、有效的,应加强健康教育工作,提高预防接种率。     

国产流感病毒裂解疫苗的免疫原性及安全性效果评价

目的观察国产流感病毒裂解疫苗的免疫原性及安全性。方法通过对疫苗接种者的随访调查和血清学检测,分析国产疫苗和进口疫苗间的免疫差异,从而对国产疫苗进行效果评价。结果接种国产疫苗和进口疫苗后,除个别有发热现象外,未发现其他异常反应,且两组的发热比率经检验差异无统计学意义;国产疫苗H1N1亚型、H3N2亚型和B型HI抗体阳转率、GMT增长倍数以及易感人群下降率,与进口疫苗相比差异均无统计学意义。结论国产疫苗具有很好的安全性和免疫原性。     

国产流行性感冒病毒裂解疫苗的安全性和免疫原性研究

目的评价国产流行性感冒（流感）病毒裂解疫苗的安全性和免疫原性。方法在江苏省盐城市建湖县选择332名观察对象,按随机、开放式的方法,开展现场观察试验。结果观察对象接种1针后局部反应率仅为0.6%,有15人次（4.5%）发生发热反应,且以轻度发热为主。血清学检测结果表明,接种疫苗后,流感病毒H1N1、H3N2、B（亚）型的HI抗体阳性率分别为95.0%、87.1%和88.1%,H1N1、H3N2、B（亚）型的HI抗体GMT增长倍数分别为33.28倍、7.76倍和26.04倍,抗体保护率分别为100.0%、99.7%、98.4%,3个型别之间阳性率、GMT增长倍数、保护率差异有统计学意义。结论国产流感病毒裂解疫苗临床安全性较好;免疫后抗体阳转率较高,抗体滴度上升幅度较大,具有良好的免疫原性,适于推广应用。