桃源居社区儿童b型流感嗜血杆菌结合疫苗副反应观察

本实验旨在观察深圳市桃源居社区儿童接种b型流感嗜血杆菌(Hib)结合疫苗后副反应情况。通过系统跟进观察398名儿童接种后情况,设置梯度进行分类,与其他参考文献及厂商资料进行比较后得出,Hib疫苗在现场接种中副反应发生率和强度低,局部反应轻微,是一种安全有效的疫苗,可以在社区儿童中广泛推广使用。     

b型和不可分型流感嗜血杆菌疫苗的研究进展

流感嗜血杆菌(Hi)是常见的条件致病菌,可引起脑膜炎、肺炎、中耳炎、败血症和会厌炎等疾病,其中,b型流感嗜血杆菌(Hib)和不可分型流感嗜血杆菌(NTHi)所致感染最为常见.疫苗接种是预防其感染最有效的手段.本文简述了Hib疫苗的发展、应用及NTHi候选疫苗的研究现状,为疾病的防治和疫苗的研发提供参考.     

中国流感嗜血杆菌流行趋势与疫苗免疫决策——2005年中国b型流感嗜血杆菌疾病及其免疫预防高层研讨会纪要

2005年8月20日，来自亚太区和欧洲的20余名预防医学专家、感染病专家、公共卫生官员以及疫苗研制专家齐聚北京，对亚太地区包括我国在内的b型流感嗜血杆菌（Hib）疾病的流行病学、疾病负担、当前Hib防治方面的困难以及Hib结合疫苗在控制该疾病发病方面的贡献进行了讨论，并为我国Hib疾病的预防提出了建议。[编者按]     

苏州地区b型流感嗜血杆菌结合疫苗对减少儿童住院肺炎有效性的观察性研究

  目的  评价接种不同剂次b型流感嗜血杆菌(Haemophilus influenzae type b, Hib)结合疫苗对儿童住院肺炎的保护效果(vaccine effectiveness, VE)。  方法  采用回顾性队列研究设计,以2018年出生并在苏州大学附属儿童医院住院的苏州地区常住儿童为研究对象,分别通过苏州大学附属儿童医院卫生信息系统和苏州市疾病预防控制中心疫苗登记数据库收集研究对象在2019年6月30日之前因肺炎住院的相关医疗信息以及Hib疫苗接种信息,比较不同剂次Hib疫苗接种组和未接种组的住院肺炎发生率,计算Hib疫苗保护效果。  结果  2018年1月1日-2019年6月30日苏州地区儿童Hib疫苗的首剂接种率为18.8%(10 080/53 753);住院肺炎发生率随接种剂次的增加而降低(χ2=-4.31, P < 0.001),其中1剂次Hib疫苗未显示保护效果,2剂次Hib疫苗已显示出保护趋势,但差异无统计学意义,接种3剂次及以上Hib疫苗的儿童住院肺炎发生率低于未接种组(RR=0.72, 95% CI: 0.59~0.89, P＜0.001),且可预防的住院肺炎发生率为1 514.8/105人年,保护效果为28%(95% CI: 11%~41%)。  结论  苏州地区3剂次及以上Hib疫苗接种可降低儿童因肺炎住院的发生率,建议推广儿童Hib疫苗接种工作,提高Hib疫苗覆盖率。     

常州市2009—2013年出生儿童b型流感嗜血杆菌疫苗接种情况

目的了解常州市b型流感嗜血杆菌(Hib)疫苗接种情况,为疫苗接种策略提供参考。方法收集常州市2009—2013年出生儿童Hib疫苗接种数据,采用描述流行病学方法进行分析。结果 2009—2013年出生儿童187 300名,Hib疫苗全程(接种≥3剂次)接种率为22.77%,呈逐年下降趋势(P<0.01)。不同性别、户籍类型、地区儿童全程接种率差异均有统计学意义(P值均<0.01)。结论常州市Hib疫苗接种率较低,应进一步分析其影响因素,提高Hib疫苗接种率。     

b型流感嗜血杆菌结合疫苗副反应观察

目的观察国产b型流感嗜血杆菌结合疫苗(以下简称Hib结合疫苗)的接种副反应。方法选择茂名市区接受Hib结合疫苗接种的适龄儿童为观察对象,观察组171名儿童接种国产Hib结合疫苗,对照组151名儿童接种进口葛兰素史克Hib结合疫苗,对接种后副反应进行追踪观察和记录。结果观察组全身总反应率为7.6%,全部为弱反应,无中、强反应出现,局部反应率为0.6%;而对照组全身总反应率为3.3%,其中弱、中、强反应率分别为1.3%1、.3%、0.7%,局部反应率为2.0%;观察组与对照组全身反应率比较差异无统计学意义(P>0.05)。结论国产Hib结合疫苗的安全性与进口结合疫苗基本相同,可广泛推广使用。     

b型流感嗜血杆菌疫苗流行病学保护效果Meta分析

目的 评价b型流感嗜血杆菌疫苗(Hib)流行病学保护效果.方法 电子检索National Centerfor Biotechnology Information(NCBI,美国国家医学图书馆数据库)和Cochrane协作网图书馆等数据库,将有关接种Hib流行病学保护效果的研究纳入分析.使用RevMan5.1软件进行统计分析.结果 共纳入7篇文献,均为随机对照试验.Hib 对流感嗜血杆菌侵袭性疾病(Hib-D)保护效果(vE)为88％(95％CI:80％ ～93％),对流感嗜血杆菌脑膜炎(HIB-M)的VE为84％(95％CI:74％～93％).结论 接种Hib可以降低因Hib感染所致侵袭性疾病和脑膜炎的发病率,具有良好的保护效果.     

b型流感嗜血杆菌结合疫苗临床研究

目的 评价b型流感嗜血杆菌(Hib)结合疫苗在3月龄～5岁婴幼儿中的安全性和免疫原性.方法 采用随机、盲态、同类制品平行对照设计,对1～5岁、7～12月龄和3～6月龄组婴幼儿分别接种b型流感嗜血杆菌结合疫苗,观察局部及全身反应,并检测血清抗体滴度.结果 3个年龄组接种Hib结合疫苗后不良反应总发生率为24.9％,1～5岁、7 ～12月龄和3～6月龄组不良反应总发生率分别为19.8％、24.9％和30.0％,其中3～6月龄试验组和对照组间不良反应总发生率差异有统计学意义(P=0.029 1),试验组高于对照组,其余2个年龄组试验组和对照组间不良反应总发生率差异无统计学意义(P =0.737 8和P=0.757 8).Hib结合疫苗免后阳转率达98.5％.达保护性水平的比例为95.6％,免后抗-Hib平均水平(GMT)为8.77 μg/ml.结论 b型流感嗜血杆菌结合疫苗接种3月龄～5周岁受试者达到良好的免疫效果,接种后具有良好的安全性及耐受性.     

Cost-effectiveness of Haemophilus influenzae type b vaccine in Vietnam

BackgroundWith GAVI support, Vietnam introduced Haemophilus influenzae type b (Hib) vaccine in 2010 without evidence on cost-effectiveness. We aimed to analyze the cost-effectiveness of Hib vaccine from societal and governmental perspectives.MethodWe constructed a decision-tree cohort model to estimate the costs and effectiveness of Hib vaccine versus no Hib vaccine for the 2011 birth cohort. The disease burden was estimated from local epidemiologic data and literature. Vaccine delivery costs were calculated from governmental reports and 2013 vaccine prices. A prospective cost-of-illness study was conducted to estimate treatment costs. The human capital approach was employed to estimate productivity loss. The incremental costs of Hib vaccine were divided by cases, deaths, and disability-adjusted life years (DALY) averted. We used the WHO recommended cost-effectiveness thresholds of an intervention being highly cost-effective if incremental costs per DALY were below GDP per capita.ResultFrom the societal perspective, incremental costs per discounted case, death and DALY averted were US$ 6252, US$ 26,476 and US$ 1231, respectively; the break-even vaccine price was US$ 0.69/dose. From the governmental perspective, the results were US$ 6954, US$ 29,449, and US$ 1373, respectively; the break-even vaccine price was US$ 0.48/dose. Vietnam's GDP per capita was US$ 1911 in 2013. In deterministic sensitivity analysis, morbidity and mortality parameters were among the most influential factors. In probabilistic sensitivity analysis, Hib vaccine had an 84% and 78% probability to be highly cost-effective from the societal and governmental perspectives, respectively.ConclusionHib vaccine was highly cost-effective from both societal and governmental perspectives. However, with GAVI support ending in 2016, the government will face a six-fold increase in its vaccine budget at the 2013 vaccine price. The variability of vaccine market prices adds an element of uncertainty. Increased government commitment and improved resource allocation decision making will be necessary to retain Hib vaccine.     

Hib结合疫苗的安全性观察

目的了解b型流感嗜血杆菌结合疫苗(Hib)的安全性,为推广使用提供依据。方法采用随机、盲态、同类制品平行对照的Ⅲ期临床试验方法,分6～12月龄、1～5岁2个年龄组,各选取900名婴幼儿,以2∶1的比例,按免疫程序分别接种受试疫苗和对照疫苗,并对接种后AEFI发生情况进行比较。结果接种受试Hib结合疫苗后,AEFI发生率为18.44%;局部、全身反应率均较低,以弱反应为主;2种疫苗间AEFI发生率差异无统计学意义(P均>0.05)。结论 2种疫苗接种后均有良好的安全性。     

A nationwide population-based surveillance of invasive Haemophilus influenzae diseases in children after the introduction of the Haemophilus influenzae type b vaccine in Japan

BackgroundHaemophilus influenzae type b (Hib) vaccine was introduced as a voluntary vaccine in December 2008 and was included in the national routine immunization program in April 2013 in Japan. Currently, no nationwide data are available to evaluate the effectiveness of Hib vaccine in Japan.MethodsTo evaluate the effectiveness of Hib vaccine in Japan, nationwide active population-based surveillance of culture-proven invasive infections caused by H. influenzae in children was performed in 2008–2017 in 10 prefectures in Japan (covering approximately 23% of the total Japanese population). Clinical data were recorded on a standardized case report form. Capsular type and antimicrobial susceptibility of the H. influenzae isolates were examined. The incidence rate ratio (IRR) and its confidence interval (CI) were calculated to compare data from 5 years before and that from after the introduction of the national routine Hib vaccine immunization program.ResultsDuring the 10-year study period, 566 invasive H. influenzae disease cases including 336 meningitis cases were identified. The average number of invasive H. influenzae disease cases among children <5 years of age during 2013–2017 decreased by 93% (IRR: 0.07, 95%CI 0.05–0.10, p < 0.001) compared with those occurring during 2008–2012. Hib strains have not been isolated from invasive H. influenzae disease cases since 2014; however, non-typeable H. influenzae and H. influenzae type f isolates have been noted as causes of invasive H. influenzae diseases among children <5 years in the post-Hib vaccine era.ConclusionsAfter the governmental subsidization of the Hib vaccine, invasive Hib disease cases decreased dramatically in the study population, as per our surveillance. Continuous surveillance is necessary to monitor the effectiveness of Hib vaccine and for detecting any emerging invasive capsular types.     

Haemophilus influenzae meningitis 5 years after introduction of the Haemophilus influenzae type b conjugate vaccine in Brazil

The long-term impact of Haemophilus influenzae type b (Hib) conjugate vaccine, introduced throughout Latin America in the late 1990s, has not been evaluated. Active surveillance for H. influenzae meningitis was performed from August 9, 1996 to August 8, 2004 in Metropolitan Salvador, Brazil. Five years after the introduction of Hib conjugate vaccine, Hib meningitis incidence decreased from 2.39 to 0.06 cases per 100,000 population (98%) overall, and from 60.9 to 3.1 cases per 100,000 population (95%) in children <1 year of age. A transient serotype replacement phenomenon was observed associated with a small increase of meningitis due to two H. influenzae type a clonal groups. These findings indicate that Hib immunization campaign has led to the virtual elimination of Hib disease in this region.     

Bacterial meningitis and Haemophilus influenzae type b conjugate vaccine, Malawi

A retrospective database review showed that Haemophilus influenzae type b conjugate vaccine decreased the annual number of cases of H. influenzae type b meningitis in children in Blantyre, Malawi. Among young bacterial meningitis patients, HIV prevalence was high (36.7% during 1997-2009), and pneumococcus was the most common etiologic agent (57% in 2009).     

Spectrum and burden of severe Haemophilus influenzae type b diseases in Asia

The validity of the commonly held view that Haemophilus influenzae type b (Hib) diseases are rare in Asia is challenged in this article by a thorough analysis of the data available, often in languages other than English. The entire spectrum of Hib disease, not only meningitis, was taken into account, and over 100 reports from 25 countries were explored. Hib was the leading agent among nontuberculous childhood meningitis cases in two-thirds of 48 studies from 22 countries. Data from six countries showed that all the classical manifestations of invasive Hib diseases are also found in Asia, except epiglottitis, which was nearly absent. In Hong Kong Special Administrative Region of China Hib disease is rare, but otherwise the incidences seemed not to deviate much from those in Europe until recently, around 25 per 100,000 for meningitis and at least 40 per 100,000 per year for the classical Hib manifestations combined at age 0-4 years. In total, more than 200,000 cases of Hib disease are estimated to occur annually in Asia. Because nonbacteraemic Hib pneumonia remains mostly undetected, the total burden is probably significantly greater. The issue will be fully elucidated only by prospective epidemiological and clinical studies, but awaiting them should not delay large-scale vaccinations against Hib throughout Asia.     

Haemophilus influenzae type b conjugate vaccine impact against purulent meningitis in Rwanda

Rwanda introduced Haemophilus influenzae type b (Hib) conjugate vaccine in January 2002 and simultaneously implemented pediatric bacterial meningitis surveillance at a major referral hospital in the capital Kigali. We reviewed clinical and laboratory information collected during January 2002 to June 2006. Due to a variety of laboratory limitations, only eight confirmed Hib cases were identified, all before 2004. However, the proportion of cerebrospinal fluid with purulence decreased from 26.0% during 2002, to 15.9% during 2003, 9.7% during 2004 and 8.4% in 2005 (p<0.001). Vaccine effectiveness of two or three doses of Hib vaccine against purulent meningitis was 52% (95% confidence interval, 5-75%). In an African setting with few resources and in which few confirmed Hib meningitis cases were identified, Hib vaccine impact nevertheless could be demonstrated against the outcome of purulent meningitis and was found to be high.