深圳市学生接种甲型H1N1流感疫苗抗体水平监测

目的了解深圳市中小学生接种甲型H1N1流感疫苗后的抗体水平,观察疫苗的保护作用。方法用常规微量血凝抑制试验,对3个时间段中小学生的流感抗体水平进行检测和比较。结果流感流行前(2009.6)抗体阳性率仅1.1%;流行后(2009.12)升至7.4%;接种疫苗后(2010)达34.9%,3个时间段的抗体阳性率逐渐增高。结论深圳市学生接种流感疫苗有一定的保护作用。     

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。     

2009年北京市大兴区健康人群甲型H1N1流感抗体水平监测及接种甲型H1N1流感疫苗免疫效果

目的了解人群甲型H1N1流感抗体水平及甲型H1N1流感疫苗的免疫效果,为甲型H1N1流感疫苗的科学使用提供依据。方法选择北京市大兴区庞各庄镇、安定镇、黄村镇、亦庄镇和兴丰街道5个地区各年龄组共200人作为人群抗体监测对象,其中各年龄组共选择50人作为免疫效果评估对象,抽取静脉血250份,采用血凝抑制实验方法测定HI抗体。结果 200人中抗体阳性者48人,阳性率为24%,几何平均滴度(GMT)为1:80.25,不同性别、地区人群的HI抗体阳性率差异无统计学意义。10～20岁和60岁以上组人群抗体阳性率最高,分别为42%和40%。监测免疫后人群50人,免疫成功率为92%,GMT是免疫前的8.7倍。结论大兴区已有24%的人群具有甲型H1N1流感保护性抗体;甲型H1N1流感疫苗具有良好的流行病学保护效果。     

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。     

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.     

中学生接种甲型H1N1流感疫苗保护效果的评价

目的 了解中学生接种甲型H1NI流感疫苗的保护效果.方法 采用非随机对照临床试验方法,选择8所中学14 883名学生,分甲型H1N1流感疫苗接种组6334人,对照组(未接种)8549人,随访观察一个流行周期(6个月),比较两组流感样病例、甲型H1N1流感病例、季节性流感病例的发生率.结果 所有研究对象累计观察7441.75人年.接种组流感样病例发病密度为21.47/1000人年,低于对照组(22.69/1000人年),差异无统计学意义(P>0.05);接种组甲型H1N1流感发病密度为0,低于对照组1.64/1000人年,两者率差为-1.64/1000人年(95%CI:-3.04～-0.23),差异有统计学意义(P=0.010);接种组流感病毒核酸阳性病例发病密度为6.63/1000人年,低于对照组(7.02/1000人年),差异无统计学意义(P>0.05);接种组乙型流感发病密度为6.63/1000人年,高于对照组(5.38/1000人年),差异无统计学意义(P>0.05).结论 学生大规模接种甲型H1N1流感疫苗能有效预防甲型H1N1流感,其保护效果良好,但对于其他季节性流感可能无交叉保护作用.

Abstract：

Objective To evaluate the epidemiological effects of vaccine immunization program related to A(H1N1)influenza in the middle school students.Methods Non-randomized clinical trial was designed to assess the A(H1N1)influenza vaccine on its efficacy.14883 students from 8 middle schools in Zhejiang province were recruited and classified into vaccinated or control groups,based on the status of immunization with A(H1N1)influenza vaccine.All subjects were followed up through one epidemic period(6 months)and the incidence rates of influenza-like illnesses,A(H1N1)influenza,and seasonal influenza in these two groups were compared to evaluate the efficacy of the vaccine.Results There were 6334 subjects in the vaccinated group and 8549 in the control group.7441.75 person-years were followed from these two groups.The incidence rate of A (H1N1)influenza in vaccinated group was 1.64‰ per person-year,lower than that of the control group.The rate difference(RD)was-1.64‰ per person-year(95% confidence interval value from-3.04‰ to-0.23‰ per person-year),and the difference was significant(P=0.010).The incidence rate of influenza-like illnesses in vaccinated group was 21.47‰ per person-year,lower than that of the control group(22.69‰ per person-year)and the diffefence was not significant(P>0.05).The incidence rate of B influenza in vaccinated group was 6.63‰ per person-year,higher than that of control group(7.02‰ per person-year)but the difference was not significant(P>0.05).Conclusion This vaccine demonstrated a good epidemiological effect against the A(H1N1)influenza virus infection,observed through a student-immunization program.The cross-protection effect against the influenza-like illnesses and other seasonal influenzas was not noticed in this study.     

怀柔区接种甲型H1N1流感疫苗分析

本文对2009年度在怀柔城区的3家预防接种保健科，进行甲型H1N1流感疫苗预防接种的实例分析，与世界卫生组织发布的全球甲型H1N1流感疫苗接种安全性评估结论基本一致，证明我国使用的疫苗安全稳定。     

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。     

甲型H1N1流感疫苗大规模人群应急接种分析

目的 控制甲型H1N1流感疫情的传播,为规范有序地应急接种提供依据.方法 按照分步实施、保证重点、知情同意、自愿接种的原则,分4个批次对浙江省象山县重点人群进行应急接种.结果 从2009年11月1日-2010年4月30日,共接种40 734人,接种率达49.83%,其中学生接种26 595人,接种率为64.34%,占总接种人数的65.29%;累计报告预防接种疑似异常反应(AEFI)15例,AEFI报告发生率为34.93/10万.结论 应用甲型H1N1流感疫苗(简称甲流疫苗)对易感人群进行应急接种是防控甲流疫情的有效手段,人群大规模甲流疫苗接种安全可行.     

2009年华容县健康人群甲型H1N1流感疫苗免疫效果分析

目的了解健康人群接种甲型H1N1流感疫苗后的免疫效果及抗体水平。方法观察接种甲型H1N1流感疫苗人群中不良反应的发生情况;按照不同的年龄组随机抽取350人,采用描叙性流行病学方法,对疫苗的安全性和有效性进行评价;微量血凝抑制试验检测接种者甲型H1N1流感病毒抗体,SPSS16.0统计学软件对接种30 d后甲型H1N1流感与普通流感的发病率、就诊率及HI抗体阳转率进行比较。结果接种组接种甲型H1N1流感疫苗30 d后甲型H1N1流感与普通流感的发病率与就诊率均低于对照组,差异有统计学意义（P〈0.05）;接种甲型H1N1流感疫苗人群中共出现不良反应1 891例,总不良反应率为4.35%;接种组总体HI抗体阳转率显著高于对照组（χ2=4.27,P〈0.05）,达到欧盟药品评价委员会的标准,各年龄组间HI抗体阳转率差异无统计学意义。结论国产甲型H1N1流感疫苗具有较高的安全性与较好的免疫原性,适合在健康人群中普遍接种。     

江苏省甲型H1N1流感裂解疫苗的免疫效果分析

2009年甲型H1N1流感的流行引起了广泛重视,接种疫苗是预防流感流行、降低死亡率和病死率的最有效方法[1],本研究通过比较不同人群甲型H1N1抗体水平变化趋势,初步评估甲型H1N1流感裂解疫苗的免疫效果. 1.对象与方法: (1)研究对象:2009年11月、12月、2010年2月,在江苏省随机选择甲型H1N1流感疫苗接种人群(免疫人群),连续采集同一批人群(共281人)免疫前、免疫后1个月及3个月的血清标本(排除季节性流感疫苗接种者和接种前1个月内有流感样症状者);连续采集甲型H1N1流感确诊病例(发病时间为2009年10月15日至11月15日,经RT-PCR检测确诊为甲型H1N1流感病毒感染[1])同一组病例发病2周内(107例)、发病后1个月(77例)及3个月(52例)的血清标本(排除甲型H1N1流感疫苗和季节性流感疫苗接种者),选择同时期自然人群作为背景资料.     

广州市甲型H1N1流感裂解疫苗人群免疫效果观察

为有效应对甲型H1N1流感疫情,评价疫苗的人群应用效果,本研究选取广州市自愿接种甲型H1N1流感疫苗的健康成年人,分别检测免前和免后第15天、第30天血清抗体滴度水平,对甲型H1N1流感裂解疫苗的人群免疫效果进行了观察.     

Lessons from pandemic influenza A(H1N1): the research-based vaccine industry's perspective

As A(H1N1) influenza enters the post-pandemic phase, health authorities around the world are reviewing the response to the pandemic. To ensure this process enhances future preparations, it is essential that perspectives are included from all relevant stakeholders, including vaccine manufacturers. This paper outlines the contribution of R&D-based influenza vaccine producers to the pandemic response, and explores lessons that can be learned to improve future preparedness.The emergence of 2009 A(H1N1) influenza led to unprecedented collaboration between global health authorities, scientists and manufacturers, resulting in the most comprehensive pandemic response ever undertaken, with a number of vaccines approved for use three months after the pandemic declaration. This response was only possible because of the extensive preparations undertaken during the last decade.During this period, manufacturers greatly increased influenza vaccine production capacity, and estimates suggest a further doubling of capacity by 2014. Producers also introduced cell-culture technology, while adjuvant and whole virion technologies significantly reduced pandemic vaccine antigen content. This substantially increased pandemic vaccine production capacity, which in July 2009 WHO estimated reached 4.9 billion doses per annum. Manufacturers also worked with health authorities to establish risk management plans for robust vaccine surveillance during the pandemic. Individual producers pledged significant donations of vaccine doses and tiered-pricing approaches for developing country supply.Based on the pandemic experience, a number of improvements would strengthen future preparedness. Technical improvements to rapidly select optimal vaccine viruses, and processes to speed up vaccine standardization, could accelerate and extend vaccine availability. Establishing vaccine supply agreements beforehand would avoid the need for complex discussions during a period of intense time pressure.Enhancing international regulatory co-operation and mutual recognition of approvals could accelerate vaccine supply, while maintaining safety standards. Strengthening communications with the public and healthcare workers using new approaches and new channels could help improve vaccine uptake. Finally, increasing seasonal vaccine coverage will be particularly important to extend and sustain pandemic vaccine production capacity.     

Delayed focal lipoatrophy after AS03-adjuvanted influenza A (H1N1) 2009 vaccine

Intramuscular vaccination may lead to loss of subcutaneous fat resulting in skin depression at the site of injection. We report for the first time a delayed lipoatrophy after with AS03-adjuvanted influenza A (H1N1) 2009 vaccine. Inadequate administration into the adipose tissue may be causative. During next pandemic, education to optimal intramuscular administration and prolonged monitoring of adverse effects could be proposed.     

Protection of trivalent inactivated influenza vaccine against hospitalizations among pandemic influenza A (H1N1) cases in Argentina

The aim of this study was to estimate the effectiveness of 2009 seasonal trivalent inactivated vaccine in reducing hospitalizations due to the novel influenza A H1N1 virus among positive cases. Data collected from Argentina's national epidemiological surveillance system were analyzed. All patients had a clinical diagnosis and underwent positive serological tests for pandemic influenza A H1N1. Logistic regression was used to estimate vaccine effectiveness to prevent severe cases of the disease, measured as hospitalizations. The adjusted effectiveness of the vaccine was 50% (95% CI: 40–59%). Vaccination was significantly associated with hospitalizations in all age groups, and within groups that had and had not received antiviral treatment. These results suggest that seasonal influenza vaccine might have conferred partial protection against severe cases due to the novel pandemic influenza.