浙江省含麻疹成分疫苗常规免疫首剂接种率估算与评价

目的 估算浙江省含麻疹成分疫苗(measles containing vaccine,MCV)常规免疫首剂(MCV1)接种率。 方法 通过中国免疫规划监测信息管理系统收集MCV常规免疫报告接种率数据。通过麻疹监测信息报告管理系统,收集麻疹病例免疫史信息,以MCV的疫苗效力(vaccine efficacy, VE)对MCV1接种率进行估算。 结果 2008 - 2010年浙江省年均MCV1报告接种率99%。以麻疹病例中免疫史比例和VE估计的13~83月龄儿童MCV1接种率为76.65%(VE=82.9%)或90.53%(VE=95%);本地儿童MCV1接种率为85.86%(VE=82.9%)或95.40%(VE=95%),流动儿童MCV1接种率为67.54%(VE=82.9%)或87.68%(VE=95%)。MCV1及时(9月龄接种)接种率为61.16%(VE=82.9%)或84.34%(VE=95%)。 结论 估算接种率与报告接种率存在较大差距,MCV1接种率和及时接种率较低。为掌握真实的MCV接种率,应使用基于预防接种个案信息的常规免疫监测系统并采用多角度、多方法的接种率评估。     

2000-2004年浙江省常规免疫监测结果分析

目的 评价浙江省常规免疫接种率报告现状、存在问题及其影响因素.方法 对2000年以来的常规免疫监测资料进行分析.结果 2000-2004年卡介苗、口服脊髓灰质炎疫苗、百白破混合制剂、麻疹疫苗、乙型肝炎疫苗的常规免疫报告接种率为98.71%～99.65%,估算接种率为72.86%～112.11%,与报告接种率之间还有差距.差值显示:全省2000年的数据为不可信,2001、2002、2004年的数据为可疑,2003年数据为可信,主要与流动儿童的计划免疫管理不完善有关.结论 单纯用上级统计年鉴人口数据进行接种率评估方法值得商榷.     

大庆市2018年常规免疫接种率监测结果分析评价

目的对大庆市2018年1月至2018年12月份的常规免疫接种率的监测结果进行评价和分析。方法采用国家常规免疫接种率监测方案中规定的方法,对2018年大庆市常规免疫监测系统报表的完整性、及时性和准确性进行评估。结果从完整性来看,大庆市各区县单位接种率报表完整性均为100.00%(详见表1)。从及时性来看,在1、2、5、7月份,共出现7次迟报情况,但并没有漏报、不报情况出现,及时性为93.52%。从免疫规划疫苗报告接种率情况来看,大庆市除甲肝疫苗为95.09%外,其他疫苗接种率都在98.00%以上。从脱漏率情况来看,大庆市120个乡级单位进行脱漏率评价,发现可信单位有47家,可疑单位为26家,不可信单位有47家。本文用比值R对同月龄免疫程序疫苗接种数据进行比较来对疫苗接种数据上报的质量进行判断,大庆市比值R评价数值为99.73,评价标准为可信。结论2018年大庆市常规免疫接种率报告质量高,监测效果明显。     

2010—2012年浙江省宁波市常规免疫监测结果分析

目的评价浙江省宁波市常规免疫接种率报告现状、存在问题以及影响因素。方法通过中国免疫规划监测信息管理系统,收集宁波市2010—2012年常规免疫接种率报告数据,并收集2010—2012年接种率调查资料,利用世界卫生组织推荐的估算方法进行接种率估算。结果 2010—2012年卡介苗、脊髓灰质炎疫苗、百白破疫苗、麻疹类疫苗、乙型病毒性肝炎(乙肝)疫苗的单苗报告接种率为99.16%~99.92%,调查接种率为93.23%~100%,估算接种率为99.16%~99.92%。乙肝疫苗及时接种率的报告接种率、调查接种率以及估算接种率分别为95.56%~98.92%、84.75%~97.79%、84.75%~98.92%,"五苗"全程合格接种率的报告接种率、调查接种率以及估算接种率分别为96.77%~99.76%、69.63%~98.30%、69.63%~99.76%。各年度本地儿童的乙肝疫苗首针及时率和"五苗"全程合格接种率均高于流动儿童。结论宁波市常规免疫监测系统日趋稳定,监测质量较好。进一步做好流动儿童接种管理工作是提高宁波市常规免疫接种率的关键。     

脊髓灰质炎三价混合糖丸疫苗三程免疫血清学效果观察

我区自1986年全面实现计划免疫冷链运转后,儿童基础免疫接种率在逐年提高。为考核全区脊灰三价混合糖丸疫苗(TOPV)投服后的免疫效果,评价免疫接种质量,指导今后接种工作,1990年4～6月,我们在全区12个县(市)内进行了 TOPV 全程投服后免疫效果监测,现将结果报告如下:观察对象和方法1.对象选择:观察对象为12月龄内按儿童免疫程序在正常冷链运转过程中完成TOPV(中国医学科学院昆明医学生物学研究所产品)三次全程基础免疫的健康儿童。     

浙江省2003年常规免疫接种率监测系统运转情况分析

目的　分析评价全省计划免疫常规免疫接种率监测系统运转情况 ,改善监测工作。方法采用《全国常规免疫接种率监测方案》规定的接种率监测评价方法 ,对报告及时性、完整性、报告接种率、估算接种率、差值 (D)、比值 ?进行评价。结果　全省及各市的基础免疫报告接种率均在97%以上 ,加强免疫在 74 %～ 99%之间。全省基础免疫估算接种率在 91%～ 96 %之间。结论　全省基础免疫报告接种率继续维持在较高水平 ,但存在薄弱地区和薄弱环节 ,特别是应种人数的掌握还不完全 ,要切实加强常规免疫接种率监测工作。     

2012年浙江省台州市常住儿童国家免疫规划疫苗接种率横断面调查

目的 初步评价2012年浙江省台州市儿童国家免疫规划疫苗的接种情况,分析影响免疫接种的相关因素。 方法 采取多阶段随机抽样,结合"见人查证核对记录"调查方法开展此项调查。 结果 2012年台州市9个县(市、区)在18个乡镇共抽查了61个行政村;共抽查2008年1月1日至2010年8月31日出生的儿童545名。调查对象中,建证率为100%,卡疤率为98.0%,脊髓灰质炎糖丸疫苗接种率为99.3%,百白破疫苗接种率为99.5%,乙肝疫苗首剂及时接种率为98.2%,含麻类疫苗首针及时接种率78.5%,"五苗"全程接种率为96.7%。 结论 2012年台州市儿童国家免疫规划疫苗的接种率均维持在较高水平,其中不合格接种的主要原因是超期接种和提前接种,其次为间隔不符。     

玉溪市1～7岁儿童脊髓灰质炎疫苗免后抗体保护效果监测

目的了解玉溪市1～7岁儿童脊髓灰质炎疫苗(OPV)免后血清抗体水平状况。方法抽选1972名1岁、4岁、7岁3个年龄组儿童,采用ELISA法进行脊髓灰质炎(脊灰)抗体水平监测。结果Ⅰ、Ⅱ、Ⅲ型抗体阳性率分别为91.63%、97.87%、99.70%,抗体几何平均滴度(GMT)分别为1:187.99、1:503.54、1:838.03;抗体阳性率和GMT在1岁、4岁、7岁组均为Ⅲ型高于Ⅱ型,Ⅰ型最低,三型抗体全阳性者占89.96%,性别间差异无统计学意义,不同地区间相对以山区为高。结论玉溪市计划免疫冷链系统运转良好,OPV接种质量得到保证,目标人群有较高的脊灰免疫抗体水平,形成了抵御脊灰的免疫屏障。     

实习前医学生乙型肝炎疫苗接种状况调查分析

[目的]了解实习前医学生乙型肝炎疫苗接种状况及影响因素,为制定医学生乙型肝炎病毒感染防护策略提供依据。[方法]采用分层整群抽样的方法,选取某医学院实习前学生为研究对象,对其乙型肝炎疫苗的接种状况进行问卷调查。[结果]355名研究对象中240人接种过乙型肝炎疫苗,34人(9.6%)未接种过疫苗,81人(22.82%)不清楚是否接种过疫苗。不同专业、不同居住地及母亲职业不同的学生乙型肝炎疫苗接种率比较差异有统计学意义(P0.05)。护理专业、居住地在城市、母亲是医生的学生疫苗接种率高,而中医专业、居住地在农村、母亲退休的学生疫苗接种率低。[结论]实习前医学生乙型肝炎疫苗接种率较低,专业、居住地及母亲职业是乙型肝炎疫苗接种率的影响因素,医学院校应加强实习前学生乙型肝炎病毒感染防护知识的健康教育,强化乙型肝炎疫苗接种工作。     

广州市海珠区儿童乙肝疫苗接种状况及保护效果分析

目的了解广州市海珠区儿童乙型肝炎(乙肝)疫苗(HepB)接种状况并评价其保护效果。方法采取多阶段随机抽样方法抽取1～20岁常住人群,对其HepB接种情况进行问卷调查,并采集静脉血检测乙肝血清学指标,描述其接种和乙肝病毒(HBV)感染状况,并分析其保护效果。结果 366名调查对象有HepB接种史为86.61%,HBV感染率为20.77%,其中有接种史者感染率为13.56%,无接种史者感染率为67.35%。按年龄进行分层后,HepB总保护率(PR)为93.3%。接种剂次越多PR越高,且接种率≥70%后接种率水平与PR呈剂量-反应关系。结论儿童接种HepB对HBV感染有很好的保护效果。     

2005年浙江省湖州市吴兴区麻疹流行特征分析

目的了解2005年浙江省湖州市吴兴区麻疹高发病率原因,以指导今后的麻疹防治工作。方法对2005年湖州市吴兴区麻疹疫情进行流行病学分析。结果2005年湖州市吴兴区麻疹发病率高达150.95/10万,发病年龄高峰为15～34岁人群(59.06%),其次为<8月龄组年龄人群(10.26%);病例职业分布前3位为工人、学生、散居儿童,外来民工是工人发病数的62.87%。8月龄以上无麻疹疫苗免疫接种史或免疫接种史不详者占91.94%;8个月至15岁以下本地儿童和流动儿童接种率分别为49.47%、22.18%。结论麻疹流行的主要原因是麻疹疫苗的初、复种率低。应落实流动儿童免疫接种制度和学生入学查验证制度,提高麻疹疫苗的初种和复种率;加强疫情监测,在成人麻疹疫情上升的地区,对免疫史不详的青壮年群体进行预防接种,防止疫情发生。     

Preventative childhood vaccination to rabies

INTRODUCTION: Rabies is prevented by post-exposure vaccination with several doses of vaccine given over 4 - 14 weeks. In case of severe exposure, the first dose of vaccine is combined with passive transfer of a rabies virus-specific immunoglobulin preparation. Preventative vaccination for rabies, also referred as pre-exposure vaccination, is reserved for humans at high risk. Although available vaccines are efficacious in preventing disease, rabies still claims the lives of an estimated 55,000 humans residing in Africa and Asia each year. Half of the death occurs in children under the age of 15. AREAS COVERED: This paper discusses whether preventative vaccination of all children in Africa and Asia, which was deemed non-cost-effective compared to post-exposure vaccination using currently licensed vaccines in Thailand, could be cost-effective using more immunogenic novel vaccines. EXPERT OPINION: At least in theory, novel one-dose rabies vaccines may be cost-effective for preventative childhood immunization, which in turn should reduce the incidence of this disease. Further clinical testing of such vaccines with the goal to develop a low-cost vaccine that can be incorporated into childhood immunization programs for areas with a high incidence of rabies-related death should be strongly encouraged.     

Impact of prior or concomitant seasonal influenza vaccination on MF59‐adjuvanted H1N1v vaccine (Focetria™) in adult and elderly subjects

Background: When H1N1v vaccines become widely available, most elderly subjects will have already received their seasonal influenza vaccination. Adults seeking H1N1v vaccination may be offered seasonal vaccine as well. We investigated prior seasonal vaccination in adult and elderly subjects, and concomitant vaccination with seasonal vaccine in adults, on the tolerability and immunogenicity of the Novartis MF59‐adjuvanted H1N1v vaccine, Focetria^®. Methods: A total of 264 adult (four groups) and 154 elderly (three groups) subjects were enrolled. The licensure study cohorts for plain (Agrippal^®) and MF59‐adjuvanted (Fluad^®) 2009–2010 seasonal vaccines were invited to receive Focetria 3 months later, with seasonal vaccine–naïve controls, and adults who received Focteria and seasonal vaccine concomitantly. Immunogenicity of all vaccines was assessed by haemagglutination inhibition on Days 1 and 22, safety and reactogenicity were monitored using patient diaries. Results: All adult and elderly groups met all the European CHMP licensing criteria for H1N1v, as did adults receiving concomitant seasonal vaccine for the three seasonal strains. Vaccines were generally well tolerated, causing no SAEs, and profiles typical of MF59‐adjuvanted vaccines. Reactions were mainly mild or moderate and transient, and unaffected by prior or concomitant seasonal vaccination except for elderly subjects previously given MF59‐adjuvanted seasonal vaccine, whose reaction rates to Focetria were about half those seen in groups receiving their first MF59 vaccine. Conclusion: One dose of MF59‐adjuvanted H1N1v vaccine met the licensure criteria for adult and elderly subjects 3 months after seasonal vaccination, or concomitantly with seasonal vaccine in adults, without impacting the tolerability or immunogenicity of either vaccine, thus facilitating mass influenza immunisation campaigns.     

Comparative immunogenicity of a genetically derived and a plasma pooled hepatitis B vaccine in normal adult volunteers

OBJECTIVE: This study compares the seroconversion rate after vaccination with genetically derived and plasma pooled vaccine in normal healthy adult volunteers. POPULATION AND METHODS: Forty volunteers of either sex were randomly divided into two groups comprising equal numbers of subjects. The mean (+/- SD) age and weight of the subjects in group A were 27.52 +/- 3.48 years and 65.60 +/- 8.06kg, respectively, while the mean (+/- SD) values for the individuals in group B were 30.75 +/- 3.78 years and 68.55 +/- 6.59kg. Recombinant and plasma pooled vaccines were administered as single 20 microg and 3 microg intramuscular injections to the respective groups of volunteers on days 1, 30, and 180. An automated system (AxSYM, based on microparticle enzyme immunoassay) was used to measure the seroconversion rate in serum harvested from an 8 mL blood sample collected within 1 month of the third dose (i.e., on day 210), from each volunteer. RESULTS: Both of the vaccines were well tolerated by all individuals and no adverse reaction was reported or observed during the study. The subject seroconversion rate corrected with reference to the cut-off rate after vaccination with DNA-derived vaccine was significantly greater (p < 0.05) than that observed after the administration of plasma pooled-derived vaccine (51.64 +/- 17.00 versus 22.96 +/- 12.04). CONCLUSION: The vaccine response, as indicated by the seroconversion rate (concentration of anti-HBs in mIU/mL) in the group vaccinated with genetically derived vaccine was observed to be better (p < 0.01) when matched with the International Antibody Standard.     

包头市九原区2006—2009年出生儿童免疫接种率调查

目的了解包头市九原区儿童免疫规划接种率现状,评价2006—2009年出生儿童接种率情况,为加强免疫规划工作,有效提高接种质量提供依据。方法采取组群抽样法抽查10个行政村、2个社区、3个农贸市场,按《预防接种工作规范》的方法进行接种率评价。结果本次共调查流动儿童120名,本地儿童124名,卡介苗（BCG）、脊髓灰质炎疫苗（OPV）、百白破三联疫苗（DPT）、麻疹疫苗（MV）、乙肝疫苗（HepB）＂五苗＂全程接种率分别89.2%、99.2%,乙肝疫苗首针及时率分别为92.5%、98.4%;全区2006—2009年出生儿童＂五苗＂全程接种率分别为91.8%、93.7%、95.0%、96.7%。结论九原区2006—2009年出生儿童免疫接种率逐年提高,均维持在较高水平;各年龄组儿童建卡建证率无显著性差异;接种率水平无性别差异;流动儿童与本地儿童接种率水平存在显著性差异,仍需加强流动儿童管理。     

Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation

Clinical development of vaccines in a pandemic situation should be rigorous but expedited to tackle the pandemic threat as fast as possible. We explored the effects of a novel vaccine trial strategy that actively identifies and enrolls subjects in local areas with high infection rates. In addition, we assessed the practical requirements needed for such a strategy. Clinical trial simulations were used to assess the effects of utilizing these so‐called “hot spot strategy” compared to a traditional vaccine field trial. We used preset parameters of a pandemic outbreak and incorporated realistic aspects of conducting a trial in a pandemic setting. Our simulations demonstrated that incorporating a hot spot strategy shortened the duration of the vaccine trial considerably, even if only one hot spot was identified during the clinical trial. The active hot spot strategy described in this paper has clear advantages compared to a “wait‐and‐see” approach that is used in traditional vaccine efficacy trials. Completion of a clinical trial can be expedited by adapting to resurgences and outbreaks that will occur in a population during a pandemic. However, this approach requires a speed of response that is unusual for a traditional phase III clinical trial. Therefore, several recommendations are made to help accomplish rapid clinical trial setup in areas identified as local outbreaks. The described model and hot spot vaccination strategy can be adjusted to disease‐specific transmission characteristics and could therefore be applied to any future pandemic threat.

Study Highlights

• WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?

Clinical development of vaccines in a pandemic situation requires a different development paradigm. It should be rigorous but expedited to tackle the pandemic threat as fast as possible. Field trials are considered pivotal, but are also the most time‐consuming stage of clinical vaccine development.

• WHAT QUESTION DID THIS STUDY ADDRESS?

Would a novel vaccine trial strategy that actively identifies and enrolls subjects in local areas with high infection rates shorten the duration of a vaccine field trial compared to the traditional wait‐and‐see approach?

• WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?

By using clinical trial simulations it was demonstrated that trial duration can be shortened considerably if local outbreaks are identified and subjects from these outbreaks are enrolled in the clinical trial. Recommendations are made to facilitate this novel approach.

• HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?

This study provides new insight in possible strategies to expedite clinical vaccine development and is in support of a more agile approach to conduct vaccine trials during a pandemic.     

Preventative childhood vaccination to rabies

Introduction: Rabies is prevented by post-exposure vaccination with several doses of vaccine given over 4 – 14 weeks. In case of severe exposure, the first dose of vaccine is combined with passive transfer of a rabies virus-specific immunoglobulin preparation. Preventative vaccination for rabies, also referred as pre-exposure vaccination, is reserved for humans at high risk. Although available vaccines are efficacious in preventing disease, rabies still claims the lives of an estimated 55,000 humans residing in Africa and Asia each year. Half of the death occurs in children under the age of 15.

Areas covered: This paper discusses whether preventative vaccination of all children in Africa and Asia, which was deemed non–cost-effective compared to post-exposure vaccination using currently licensed vaccines in Thailand, could be cost-effective using more immunogenic novel vaccines.

Expert opinion: At least in theory, novel one-dose rabies vaccines may be cost-effective for preventative childhood immunization, which in turn should reduce the incidence of this disease. Further clinical testing of such vaccines with the goal to develop a low-cost vaccine that can be incorporated into childhood immunization programs for areas with a high incidence of rabies-related death should be strongly encouraged.     

The choice of vaccine for post partum rubella vaccination (author's transl)]

Meruvax vaccine was compared with Cendevax in post partum rubella vaccination. The obstetricians in Vienna routinely use the Cendevax vaccine at present. In accordance with an earlier study on Almevax, the third vaccine available in Austria, the results with Meruvax were slightly better than with Cendevax. However, this is possibly due to a longer period of storage of the vaccine used in mass vaccination programmes. Hence, the three vaccines should be tested under the same practical conditions to decide which vaccine should be used routinely.     

北京市丰台区社区卫生服务中心医务人员流感疫苗接种现状、推荐意愿及影响因素

  目的  了解北京市丰台区社区卫生服务中心医务人员流感疫苗接种现状、推荐意愿及影响因素,为提高该人群流感疫苗接种率提供依据。  方法  采用自行设计的问卷,对北京市丰台区23家社区卫生服务中心的医务人员和公卫科负责人分别进行调查和访谈。 了解流感及流感疫苗的认知情况、2018 — 2019年度流感疫苗接种现状和推荐意愿、医务人员接种流感疫苗的相关政策等内容,采用非条件多因素logistic回归分析流感疫苗接种现状和推荐意愿的影响因素。  结果  共回收有效问卷1 359份,应答率平均为58.48%（1 359/2 324）,2018 — 2019年流感疫苗调整权重后接种率为32.81%,推荐率为79.76%（1 084/1 359）。 公共卫生等科室、知晓疫苗效果、知晓疫苗接种时间、知晓医务人员是我国推荐优先接种流感疫苗的人群、单位免费提供等因素促进流感疫苗接种。 年龄较大、医师和护士等岗位、既往接种流感疫苗、流感及流感疫苗知识得分高等因素促进流感疫苗推荐意愿。 78.26%（18/23）受访者认为流感疫苗接种率不高的原因主要是流感疫苗未免费。 91.30%（22/23）受访者建议加强流感和流感疫苗知识宣传以提高流感疫苗接种率。  结论  丰台区社区卫生服务中心医务人员流感疫苗接种率较低,推荐率较高,为医务人员免费提供疫苗并针对性开展宣传教育是提高该人群流感疫苗接种率的关键。     

Incidence of adverse reactions to COVID-19 vaccination:A meta-analysis of randomized controlled trials

Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang Data,and VIP Database from the inception of each database to August 31,2021.Randomized controlled clinical trials(RCTs)on the safety of different types of COVID-19 vaccines were retrieved and analyzed.A random or fixed-effects model was used with an odds ratio as the effect size.The quality of each reference was evaluated.The incidence of the adverse reactions of the placebo group and the vaccination group was compared.Heterogeneity and publication bias were taken care of by meta-regression and sub-group analyses.Results:A total of 13 articles were included,with 81287 subjects.Compared with the placebo group,the vaccination group showed a higher combined risk ratio(RR)of total adverse reactions(RR=1.67,95%CI:1.46-1.91,P<0.01),local adverse reactions(RR=2.86,95%CI:2.11-3.87,P<0.01),systemic adverse reactions(RR=1.25,95%CI:0.92-1.72,P=0.16),pain(RR=2.55,95%CI:1.75-3.70,P<0.01),swelling(RR=4.16,95%CI:1.71-10.17,P=0.002),fever(RR=2.34,95%CI:1.84-2.97,P<0.01),fatigue(RR=1.36,95%CI:1.32-1.41,P<0.01)and headache(RR=1.22,95%CI:1.18-1.26,P<0.01).The subgroup analysis showed the incidence of adverse reactions of the vaccination group after injection of the three COVID-19 vaccines(inactivated viral vaccines,mRNA vaccines and adenovirus vector vaccines)was higher than that of the placebo group,and the difference between the placebo group and the vaccination group in the mRNA vaccine subgroup and the adenovirus vector vaccine subgroup was statistically significant(P<0.01).The incidence of adverse reactions after injection of COVID-19 vaccine in subgroups of different ages was significantly higher than that in the placebo group(P<0.01).Conclusions:COVID-19 vaccines have a good safety,among which adenovirus vector vaccine has the highest incidence of adverse reactions.Both adolescents and adults vaccinated with novel coronavirus vaccine have a certain proportion of adverse reactions,but the symptoms are mild and can be relieved by themselves.Our meta-analysis can help boost global awareness of vaccine safety,promote mass vaccination,help build regional and global immune barriers and effectively curb the recurrency of COVID-19.