关键词： Polio virus vaccine   Injectable polio vaccine   Immunity   Seroconversion   Seroprevalence   Pakistan  

摘要： Background: Considering the current polio situation Pakistan needs vaccine combinations to reach maximum population level immunity. The trial assessed whether inactivated poliovirus vaccine (IPV) can be used to rapidly boost immunity among children in Pakistan. Methods: A five-arm randomized clinical trial was conducted among children (6-24 months, 5-6 years and 10-11 years). Children were randomized in four intervention arms as per the vaccines they received (bOPV, IPV, bOPV + vitamin A, and bOPV + IPV) and a control arm which did not receive any vaccine. Baseline seroprevalence of poliovirus antibodies and serological immune response 28 days after intervention were assessed. Results: The baseline seroprevalence was high for all serotypes and the three age groups [PV1: 97%, 100%, 96%, PV2: 86%, 100%, 99%, PV3: 83%, 95%, 87% for the three age groups respectively]. There was significantly higher rate of immune response observed in the study arms which included IPV (95-99%) compared with bOPV only arms (11-43%), [p < 0.001];Vitamin A was not associated with improved immune response. Immune response rates in the IPV only arm and IPV + bOPV arm were similar [p > 0.5]. Conclusion: IPV has shown the ability to efficiently close existing immunity gaps in a vulnerable population of children in rural Pakistan. (C) 2016 Elsevier Ltd. All rights reserved.

关键词： Drug delivery   Vaccine delivery   Single-administration vaccines   Controlled release kinetics   Vaccine stability  

摘要： Vaccines are a critical clinical tool in preventing illness and death due to infectious diseases and are regularly administered to children and adults across the globe. In order to obtain full protection from many vaccines, an individual needs to receive multiple doses over the course of months. However, vaccine administration in developing countries is limited by the difficulty in consistently delivering a second or third dose, and some vaccines, including the inactivated polio vaccine (IPV), must be injected more than once for efficacy. In addition, IPV does not remain stable over time at elevated temperatures, such as those it would encounter over time in the body if it were to be injected as a single-administration vaccine. In this manuscript, we describe microspheres composed of poly(lactic-co-glycolic acid) (PLGA) that can encapsulate IPV along with stabilizing excipients and release immunogenic IPV over the course of several weeks. Additionally, pH-sensitive, cationic dopants such as Eudragit E polymer caused clinically relevant amounts of stable IPV release upon degradation of the PLGA matrix. Specifically, IPV was released in two separate bursts, mimicking the delivery of two boluses approximately one month apart. In one of our top formulations, 1.4, 1.1, and 1.2 doses of the IPV serotype 1, 2, and 3, respectively, were released within the first few days from 50 mg of particles. During the delayed, second burst, 0.5, 0.8, and 0.6 doses of each serotype, respectively, were released;thus, 50 mg of these particles released approximately two clinical doses spaced a month apart. Immunization of rats with the leading microsphere formulation showed more robust and long-lasting humoral immune response compared to a single bolus injection and was statistically non-inferior from two bolus injections spaced 1 month apart. By minimizing the number of administrations of a vaccine, such as IPV, this technology can serve as a tool to aid in the eradication of polio and ot

摘要： Background Replacement of the trivalent oral poliovirus vaccine (tOPV) with bivalent types 1 and 3 oral poliovirus vaccine (bOPV) and global introduction of inactivated poliovirus vaccine (IPV) are major steps in the polio endgame strategy. In this study, we assessed humoral and intestinal immunity in Latin American infants after three doses of bOPV combined with zero, one, or two doses of IPV. Methods This open-label randomised controlled multicentre trial was part of a larger study. 6-week-old full-term infants due for their first polio vaccinations, who were healthy on physical examination, with no obvious medical conditions and no known chronic medical disorders, were enrolled from four investigational sites in Colombia, Dominican Republic, Guatemala, and Panama. The infants were randomly assigned by permuted block randomisation (through the use of a computer-generated list, block size 36) to nine groups, of which five will be discussed in this report. These five groups were randomly assigned 1: 1: 1: 1 to four permutations of schedule: groups 1 and 2 (control groups) received bOPV at 6, 10, and 14 weeks;group 3 (also a control group, which did not count as a permutation) received tOPV at 6, 10, and 14 weeks;group 4 received bOPV plus one dose of IPV at 14 weeks;and group 5 received bOPV plus two doses of IPV at 14 and 36 weeks. Infants in all groups were challenged with monovalent type 2 vaccine (mOPV2) at 18 weeks (groups 1, 3, and 4) or 40 weeks (groups 2 and 5). The primary objective was to assess the superiority of bOPV-IPV schedules over bOPV alone, as assessed by the primary endpoints of humoral immunity (neutralising antibodies-ie, seroconversion) to all three serotypes and intestinal immunity (faecal viral shedding post-challenge) to serotype 2, analysed in the per-protocol population. Serious and medically important adverse events were monitored for up to 6 months after the study vaccination. This study is registered with ***, number NCT

关键词： 脊髓灰质炎   灭活疫苗   工艺布置   GMP  

摘要： 医药工业洁净厂房是疫苗生产的硬件基础,在医药厂房设计中,工艺专业是主导专业,起着非常重要的作用。以某脊髓灰质炎灭活疫苗原液生产车间为例,主要从工艺流程、平面布局和有毒区控制等方面对车间的工艺布置设计进行了分析。

关键词： 脊髓灰质炎   灭活疫苗   减毒活疫苗   保护效果   安全性   Meta分析  

摘要： 目的比较脊髓灰质炎灭活疫苗和减毒活疫苗的免疫原性与安全性的差异。方法检索美国国家医学图书馆数据库（NCBI），Cochrane协作网图书馆（CL）、中国期刊网全文数据库（CNKI）、万方医学网等数据库中检索，收集接种脊髓灰质炎灭活疫苗和减毒活疫苗的免疫原性与安全性的随机对照研究，提取资料和评估方法学质量，采用Review Manager5．0软件对2种疫苗的保护效果及安全性进行Meta分析，二分类变量用相对危险度（RR）和95％可信区间CI（95％）表达，连续变量用标准均数差（SMD）及其95％CI表达。结果纳入6项随机对照研究。在不考虑脊髓灰质炎疫苗接种总剂次数的前提下，Meta分析显示，IPV接种组较OPV接种组可以提高幼儿脊髓灰质炎TypeⅢ型保护效果为[RR合并=1．16，95％CI：1．12—1．20），P〈0．01]，但疫苗的安全性[RR合并=1．03，95％C1：0．88，1．20），P〉0．05]差异无统计学意义。结论脊髓灰质炎灭活疫苗针对脊髓灰质炎病毒TypeⅢ具有较好保护效果。

关键词： 脊髓灰质炎疫苗   脊髓灰质炎疫苗相关病例   预防接种  

摘要： 1病例摘要 病例1，男，2011年7月20日出生。于2011年9月23日在双桥区桥东社区卫生服务中心，服下第1剂次脊髓灰质炎减毒活疫苗（OPV）。10月1日，家长发现患儿肛门周围出现1包块，随即包块逐渐增大。7日到承德医学院附属医院住院治疗。在全麻下进行了肛周脓肿切开引流术。

关键词： 脊髓灰质炎   病毒   新希望   抗癌   编辑技术   遗传编码   小儿麻痹症   研究人员  

摘要： 脊髓灰质炎病毒是引起脊髓灰质炎，也就是小儿麻痹症的病毒。近期，科学家们让脊髓灰质炎病毒“改头换面”，变成了对付癌细胞的武器。美国杜克大学的研究人员利用基因编辑技术，将脊髓灰质炎病毒本身可致病的遗传编码替换成了感冒病毒中的一段遗传编码，从而去除了病毒的致病能力。经过基因编辑的病毒被称为PVS-RIPO。

关键词： 疫苗接种   or   儿保医生   儿童保健科   轮状病毒疫苗   脊髓灰质炎疫苗   流感疫苗   麻疹疫苗   乙肝疫苗   流感病毒疫苗  

摘要： 妈妈们对疫苗的知识通常了解得较少,像Ⅰ类、Ⅱ类疫苗的重要性以及哪些一定要接种,哪些可以选择性接种等,妈妈们都心存疑问。让我们一起来帮助正在纠结疫苗问题的妈妈们吧!

关键词： 脊髓灰质炎   正确选择   疫苗接种  

摘要： 按照计划我家宝宝需要接种脊髓灰质炎疫苗了,有人跟我说不要去吃'糖丸',说吃了会致病,我该怎么选择?山东读者李优国内目前存在脊髓灰质炎减活疫苗、灭活疫苗(IPV)及包含IpV的五联苗可供选择。'糖丸'是一种减毒活疫苗,用于预防脊髓灰质炎。口服糖丸后发生疫苗相关麻痹病例应该是一个极小概率事件,概率约在一百万分之一。

关键词： POLIOVIRUS   POLIOMYELITIS vaccine   EPIDEMIOLOGY   VIRAL genomes   SEROTYPES  

摘要： Four cases of acute flaccid paralysis caused by slightly evolved (Sabin-like) vaccine polioviruses of serotype 2 were registered in July to August 2010 in an orphanage of Biysk (Altai Region, Russia). The Biysk cluster of vaccine-associated paralytic poliomyelitis (VAPP) had several uncommon, if not unique, features. (i) Until this outbreak, Sabin-like viruses ( in distinction to more markedly evolved vaccine-derived polioviruses [VDPVs]) were reported to cause only sporadic cases of VAPP. Consequently, VAPP cases were not considered to require outbreak-type responses. However, the Biysk outbreak completely blurred the borderline between Sabin-like viruses and VDPVs in epidemiological terms. (ii) The outbreak demonstrated a very high disease/infection ratio, apparently exceeding even that reported for wild polioviruses. The viral genome structures did not provide any substantial hints as to the underlying reason(s) for such pathogenicity. (iii) The replacement of intestinal poliovirus lineages by other Sabin-like lineages during short intervals after the disease onsets was observed in two patients. Again, the sequences of the respective genomes provided no clues to explain these events. (iv) The polioviruses isolated from the patients and their contacts demonstrated a striking heterogeneity as well as rapid and uneven evolution of the whole genomes and their parts, apparently due to extensive interpersonal contacts in a relatively small closed community, multiple bottlenecking, and recombination. Altogether, the results demonstrate several new aspects of pathogenicity, epidemiology, and evolution of vaccine-related polioviruses and underscore several serious gaps in understanding these problems. IMPORTANCE The oral poliovirus vaccine largely contributed to the nearly complete disappearance of poliovirus-caused poliomyelitis. Being generally safe, it can, in some cases, result in a paralytic disease. Two types of such outcomes are distinguished: those caused by sligh