Safety observation of attenuated live hepatitis B vaccine (H2 strain) in humans

3089 healthy persons, aged 4 to 27 years, have been inoculated in 3 batches with attenuated live hepatitis A vaccine (H2 strain) since May, 1987. Each subject received 10(8.5) TCID dosage subcutaneously in the upper arm. None of the recipients developed any local or systemic reaction during a 42-day followup after vaccination. The serum enzyme activities, including SGPT/ALT and LDH5, were within normal range during the 4th to 16th weeks of serial tests after inoculation. The study of hepatitis A virus (HAV) shedding in feces of 4 subjects showed that no hepatitis A antigen (HAAg) was detected with antigen capture ELISA, but infectious HAV was recovered from stool-cell cultures in three of four recipients. No patient with hepatitis A was found within 6 months after vaccination in the institution where the HAV vaccine was used. In addition, no immunological evidence was seen that the HAV vaccine recipients can transmit HAV after the investigation of serological epidemiology at a class in which the HAV vaccine was tested. It is suggested that the potential of hepatitis A related to HAV vaccine among the non-vaccinated persons is rare. Seroconversion occurred at a mean time of 2 to 5 weeks after inoculation, and the positive rate of specific antibody was 95.6%.     

甘肃省1～59岁人群乙型肝炎疫苗接种率调查分析

目的了解甘肃省1～59岁人群乙型肝炎疫苗（HepB）接种情况,为乙肝预防控制策略提供依据。方法采用多阶段随机抽样方法确定1～59岁调查对象,对抽样人群HepB接种情况进行调查。结果甘肃省1～59岁人群HepB接种率为48.18%,其中1～4岁儿童为89.37%,10～14岁儿童为55.40%,15～59岁人群仅为10.99%,HepB接种率呈现随年龄年龄增加而降低;托幼儿童接种率高于散居儿童,农民最低,医务人员接种率为46.15%;不同职业人群HepB接种率差异具有统计学意义。1～14岁儿童HepB首针及时接种率为46.79%,2岁儿童最高为72.81%;HepB首针及时接种率随年龄增长而降低。结论乙肝疫苗纳入计划免疫后出生的儿童乙肝疫苗接种率高,15岁以上人群接种率低,要加速我国控制乙肝步伐,必须提高重点和高危人群乙肝疫苗接种率。     

Control of hepatitis A through routine vaccination of children.

CONTEXT: The impact of routine hepatitis A vaccination of children living in large communities with elevated disease rates has not been evaluated. OBJECTIVE: To determine the effect of routine vaccination of children on disease incidence in a community with recurrent hepatitis A epidemics. DESIGN, SETTING, AND PARTICIPANTS: Community-based demonstration project conducted from January 12, 1995, through December 31, 2000, in Butte County, California, among children aged 2 to 17 years. INTERVENTION: In 1995, vaccination was offered to children aged 2 to 12 years during vaccination clinics conducted on 2 occasions 6 to 12 months apart at most schools in the county. In 1996-2000, vaccine was distributed to community health care clinicians, who vaccinated eligible children without charge. Vaccine was also available at health department clinics, selected child care centers, and other sites. MAIN OUTCOME MEASURES: Hepatitis A vaccination coverage, hepatitis A incidence, and vaccine effectiveness. RESULTS: During the study period, 29 789 (66.2%) of an estimated 44 982 eligible children received at least 1 vaccine dose; 17 681 (39.3%) received a second dose. The number of hepatitis A cases among the entire county population declined 93.5% during the study period, from 57 cases in 1995 to 4 in 2000, the lowest number of cases reported in the county since hepatitis A surveillance began in 1966. The 2000 incidence rate of 1.9 per 100 000 population was the lowest of any county in the state. Of the 245 cases reported during the 6-year period, 40 (16.3%) occurred among children 17 years of age or younger, of which 16 (40%) occurred in 1995 and only 1 in 2000. One of the 27 case patients eligible for vaccination had been vaccinated, having received the first dose 3 days before symptom onset. The estimated protective vaccine efficacy was 98% (95% confidence interval, 86%-100%). CONCLUSIONS: In this population, hepatitis A vaccine was highly effective in preventing disease among recipients. Childhood vaccination appears to have decreased hepatitis A incidence among children and adults and controlled the disease in a community with recurrent epidemics.     

甲型肝炎灭活疫苗和冻干减毒活疫苗接种后1年的免疫原性研究

目的评价甲型肝炎灭活疫苗和冻干减毒活疫苗接种1剂1年后的免疫原性。方法采用单一中心随机双盲试验设计,对18月龄~4岁健康幼儿受试者随机接种1剂设盲的甲肝灭活疫苗或甲肝减毒活疫苗。接种前及接种后12个月,采用微粒子酶免法（MEIA）定量检测受试者甲型肝炎抗体（抗-HAV）。结果免疫后1年,甲肝灭活疫苗组和甲肝减毒疫苗组分别有124人和135人完成试验,抗-HAV阳转率分别为95.2%和91.1%,抗-HAV的几何平均浓度（GMC）分别为101.7 IU/L和65.5 IU/L,甲肝灭活疫苗免疫的抗体水平明显高于甲肝减毒活疫苗（P〈0.001）。结论接种1剂甲肝灭活疫苗或甲肝减毒活疫苗后12个月,均可产生良好的免疫效应,甲肝灭活疫苗免疫的抗体水平明显高于甲肝减毒活疫苗。     

深圳市大浪街道5～12岁儿童腮腺炎疫苗未种原因调查分析

目的了解2011年深圳市大浪辖区5~12岁的儿童腮腺炎疫苗接种情况,分析该疫苗未种的主要影响因素,为将腮腺炎疫苗纳入该年龄组的免疫规划程序及控制相关传染病提供依据。方法选取深圳市大浪辖区2007年3月1日前出生的儿童作为调查对象,采用问卷调查的方法 ,分析该年龄段儿童腮腺炎疫苗接种情况。结果在600名调查儿童中,麻疹疫苗接种率为99%(594人);腮腺炎疫苗接种率为61%(365人),未种率为39%(235人)。腮腺炎疫苗主要未种原因:48.51%(114人)认为腮腺炎疫苗不是免费疫苗,接种人员没建议接种;23.40%(55人)认为腮腺炎疫苗不是免疫规划内疫苗,没时间接种;28.08%(66人)认为腮腺炎疫苗不重要。97%的调查儿童家长表示如果将麻腮风疫苗(MMR)纳入国家规划内免费疫苗,愿意让其小孩接种该疫苗。结论麻腮风三联疫苗的免费接种范围不能覆盖腮腺炎发病的主要人群(5~12岁儿童),自费接种或无正确的接种指引是腮腺炎接种率低的主要原因,建议将麻腮风三联疫苗免疫规划范围扩大到2007年3月1日前出生儿童,覆盖5~12岁儿童,建立起腮腺炎的人群免疫屏障。     

儿童甲肝、风疹减毒活疫苗同时免疫效果观察

目的了解甲肝与风疹减毒活疫苗同时免疫的效果。方法对荆州市妇幼保健院预防接种门诊的356名1岁3个月至2岁的儿童进行免疫监测,并按同时免疫组与单独免疫组进行效果分析。结果同时免疫与单独免疫应答率差异无统计学意义(P>0.05),但同时免疫组两种疫苗的抗体几何平均滴度(GMT)明显高于单独组。结论采用同时免疫方法可增加疫苗的抗体几何平均滴度。     

Intradermal inoculation with Heptavax-B. Immune response and histologic evaluation of injection sites

The high cost of hepatitis B vaccine has limited its widespread use. Low-dose, intradermal injections of vaccine represent one option for reducing the cost. In this study, 92 nonimmune medical students were given three 0.1-mL intradermal injections of Heptavax-B containing 2 micrograms of hepatitis B surface antigen (HBsAg) at 0, 1, and 6 months. By 6 months, 90% of the subjects had developed protective levels of antibody to HBsAg (greater than or equal to 10 mIU/mL). Follow-up at 1 year showed a geometric mean concentration of antibodies to HBsAg of 396 mIU/mL for the group, and 95% had levels of antibody to HBsAg greater than or equal to 10 mIU/mL. A level of antibody to HBsAg of greater than 100 mIU/mL also was observed in more than 75% of subjects. Side effects included induration of the inoculation site in 18% at 6 months, which disappeared by 12 months, and macules that persisted at 1 year in 63%. The administration of hepatitis B vaccine intradermally is an attractive, low-cost alternative in the United States, where universal vaccination of preschool children or adolescents is being contemplated, and where booster doses are being considered.     

无锡某社区14岁以下儿童乙肝疫苗接种及乙肝病毒感染情况调查分析

目的了解儿童乙肝疫苗接种及乙肝病毒（HBV）感染情况,为制定或调整乙肝疫苗接种策略提供依据。方法随机选取无锡市某社区534名1-14岁常住儿童作为调查对象,对其进行乙肝疫苗接种情况问卷调查,并通过酶联免疫吸附法（ELISA）检测血清中乙肝病毒表面抗原（HBsAg）、乙肝病毒表面抗体（抗-HBs）和乙肝病毒核心抗体（抗-HBc）三项指标。结果该社区1-14岁儿童乙肝疫苗接种率和首针及时接种率分别为97.75%和91.57%,6岁以下两组儿童乙肝疫苗接种率和首针及时接种率差异无统计学意义（P〉0.05）,7-14岁儿童乙肝疫苗接种率和首针及时接种率均低于1-6岁儿童（P〈0.01）;HBV感染率随年龄增长呈递增趋势,1-6岁儿童HBV感染率低于7-14岁儿童（P〈0.05）。结论近年来无锡市儿童乙型肝炎防治效果显著,加强儿童乙肝疫苗接种工作,特别是提高疫苗接种率对于防治HBV感染意义重大。     

Persistence of influenza serum antibodies in humans following immunization with a bivalent A/Victoria and A/New Jersey vaccine.

The persistence of serum antibodies 1 year after immunization with a bivalent vaccine containing recombinant viruses that were antigenically identical with A/Victoria/3/75 (H3N2) and A/New Jersey/8/76 (Hsw1N1) viruses was measured in 128 persons aged 18 to 65 years. Serum samples were tested with the hemagglutination inhibition assay against the two vaccine antigens and against A/Texas/1/77 (H3N2) and A/USSR/90/77 (H1N1) viruses. Prior to vaccination 56% and 79% of the participants had been found to be seronegative to A/Victoria and A/New Jersey antigens respectively; the geometric mean antibody titres were low (1:5 to 1:11) except in persons aged 51 to 65 years, whose mean titre of antibody to the A/New Jersey antigen was 1:23, and persons aged 26 to 35 years, whose mean titre of antibody to the A/USSR antigen was 1:25. By 3 weeks after vaccination 85% of the seronegative persons had a fourfold or greater rise in titres of antibodies to the viruses in the vaccine, and 70% had a fourfold increase in titre of antibody to the A/Texas antigen. Of the persons aged 26 to 35 years (seronegative and seropositive) 68% had a fourfold or greater increase in titre of antibody to the A/USSR antigen. There was no change in the mean titres of 19 unvaccinated control subjects during the observation period. At 6 and 12 months after vaccination the titres of antibodies to the A/Victoria and A/New Jersey antigens had declined moderately in all age groups from those observed 3 weeks after vaccination. The rate of decline was similar for the various antibodies except that to the A/USSR antigen in persons 26 to 35 years of age, in whom the decline was much slower.     

海南省甲肝疫苗安全性及有效性评价

目的 了解海南省甲型病毒性肝炎(甲肝)的发病动态及流行特征,评价2008年甲肝疫苗纳入免疫规划后,在海南省使用的甲肝疫苗预防接种的安全性和有效性,为预防接种实施和控制提供策略依据。方法 收集2005年以来不同时期海南省甲肝疫情、人口统计和接种资料及2010—2014年甲肝疫苗接种后疑似预防接种异常反应(adverse events following immunization; AEFI)监测资料,从甲肝发病率、疫苗保护率、异常反应发生率、临床类型等流行病学指标评价其有效性和安全性。结果 海南省2005—2014年甲肝发病率为1.04/10万~11.35/10万,年均发病率为4.20/10万;2005—2007年甲肝疫苗未纳入扩大免疫规划(Expanded Programme on Immunization,EPI)时期,共报告甲肝2 173例,总报告发病率8.69/10万;2008—2010年甲肝减毒活疫苗分地区纳入EPI过渡时期,共报告甲肝893例,总报告发病率为3.38/10万;2011—2014年甲肝减毒活疫苗完全纳入EPI期,共报告甲肝538例,总报告发病率为1.48/10万;2010—2014年甲肝疫苗年均接种率为99.67%,年均保护率为99.97%;2008—2014年海南省5岁以下儿童甲肝发病率与甲肝疫苗接种率呈高度负相关(r=–0.862)。接种甲肝疫苗后报告AEFI病例179例,其中减毒活疫苗169例,总发生率为2.65/万;灭活疫苗10例,总发生率为1.52/万;两者以一般反应(发热/红肿/硬结),绝大多数反应均为一过性;异常反应主要表现为过敏性皮疹,严重异常反应如过敏性休克和过敏性紫癜发生率等发生率均为0.03/万~0.06/万。结论 海南省将甲肝减毒活疫苗纳入儿童计划免疫推广应用效果显著,两种工艺甲肝疫苗安全性均较高,可继续推广应用。     

132名低龄儿童应用甲型肝炎灭活疫苗初次免疫效果观察

目的 为了评价孩尔来福甲型肝炎灭活疫苗在本地区低龄儿童应用中的初次免疫效果。方法 对初次应用甲型肝炎灭活疫苗免疫的2～6岁甲肝易感儿童132人随机分成4组,观察初次免疫后局部反应和全身反应,检测免疫后1、3、6．7个月的血清抗甲肝病毒抗体（抗-HAV）阳转率和滴度（GUT）。结果 显示孩尔来福甲型肝炎无局部及全身反应,初次免疫后1、3、6、7个月抗-HAV阳转率分别为100％、97．83％、100％、100％,抗-HAV滴度分别为744．35mIU／ml、524．41mIU／ml、354．34mIU／ml、333．13mIU／ml。结论 各组之间差异无显著的统计学意义。表明孩尔来福甲型肝炎灭活疫苗在低龄儿童中应用是非常安全的;并且具有良好的免疫效果：儿童型每剂含病毒抗原250U,适用于儿童接种。     

Vaccination of School Children With Live Mumps Virus Vaccine

Live, attenuated mumps virus vaccine (Mumpsvax) was administered to 146 school children 6 to 9 years of age. One child developed clinical mumps nine days after vaccination; epidemiological and serological data strongly suggest that this child had become infected before vaccination. Apart from this single instance there were no apparent clinical reactions that could be ascribed to the administration of the vaccine. Sixty-three of the 146 children with no clinical history of mumps had an initial serum neutralizing antibody titre of less than 1:2. Specific antibodies to mumps virus were detected in 93.5% of the sera of the susceptible children 28 days after vaccination, and the geometric mean antibody titre of these sera was low (1:6). Of the 80 initially seropositive children 21 (26.2%) showed a significant antibody response to the vaccine and this was influenced by the pre-existing antibody level. These data have further demonstrated the safety and efficacy of the live mumps vaccine in children.     

甲型肝炎减毒活疫苗与灭活疫苗免疫效果的比较

目的 观察甲型肝炎（甲肝）减毒活疫苗Ｈ２株与ＬＡ－１株的不同剂量、不同免疫程序的免疫原性及抗体动脉变化。方法 在河北、广西两地５选择３１８名经甲肝抗体检测为阴性的易感儿童,按不同剂量程序及不同甲肝疫苗,分为６组,并在首剂接种后１、６、７、１２、１３月份分别采集血清标本,检测甲肝总抗体。结果 各组抗体水平均于再免疫后１个月达高峰,以后开始下降,再免半年后抗体水平仍明显高于初免抗体水平;灭活于再免疫后     

Vaccination against hepatitis B: the Chinese experience

Objective To review the implementation of mass vaccination of hepatitis B vaccine and its critical role in prevention of hepatitis B virus infection in China.
Data sources The data were mainly from PubMed, China Hospital Knowledge Database, and other popular Chinese journals published from 1980 to 2008. The search term was ＂hepatitis B vaccine＂.
Study selection Original studies conducted in China and critical reviews authored by principal investigators in the field of hepatology in China were selected.
Results Chinese investigators started to develop hepatitis B vaccine in late 1970s. The first home-made plasma-derived vaccine became available in 1986, which has been completely replaced by the domestically produced recombinant （yeast or Chinese hamster ovary cell） vaccine since 2001. China health authority recommended vaccinating all infants in 1992. From then on, China has put tremendous efforts in implementation of mass vaccination. The overall coverage of hepatitis B vaccine in infants has increased steadily and reached more than 95.0% in urban and 83.0%-97.0% in rural areas. The chronic HBV carrier rate in children 〈10 years of age decreased from 10.0% before the mass vaccination to 1.0%-2.0% in 2006, and that in general population decreased from 10.0% to 7.2%; overall, the nationwide mass hepatitis B vaccination has reduced more than 30 million of chronic HBV infections and HBV related severe sequlae.
Conclusion The Chinese successful experience in control of hepatitis B by mass vaccination offers an example for any unindustrialized country whoever is committed to control this disease.     

海南省2010年麻疹强化免疫效果评价

摘要：目的分析评价海南省2010年麻疹减毒活疫苗（Mv）强化免疫效果。方法综合分析麻疹强化免疫接种率、麻疹监测系统资料及AEFI监测系统资料。结果全省强化免疫共接种8月龄～6岁目标儿童772850人,报告接种率为96．93％,其中常住儿童报告接种率为97．05％,流动儿童报告接种率96．19％,两组人群强化免疫接种率差异有统计学意义（x2=-253．557,P〈0．05）,分年龄组报告接种率均〉95％,系统评估接种率为97．7％,调查两市县接种率无统计学意义（x2=0．812,P〉0．05）,2010年、2011年、2012年全省麻疹发病率分别为0．5／100万,0．47／100万、0．33／100万。结论海南省2010年开展NV强化免疫进一步提高了8月龄～6岁儿童MV的接种率,确保了适龄儿童MV抗体水平,并形成人群有效的免疫屏障,从而巩固了我省提前消除麻疹的现有成绩,但是要确保实现2012年消除麻疹的目标,必须在确保常规免疫高接种率的同时进一步提高mv及时接种率,同时开展流动人口查漏补种工作。     

Vaccination against hepatitis A in children aged 12 to 24 months [corrected

BACKGROUND: Current hepatitis A vaccines are either licensed for children >2 years of age, as in the U.S. or Chile, or >1 year of age, as in Europe and other parts of the world. Recent recommendations for immunization against hepatitis A have included routine vaccination of children in areas or regions of higher endemicity. However, data on hepatitis A vaccination in toddlers aged between 1 and 2 years are scarce. METHODS: This open clinical study investigated the reactogenicity and immunogenicity of two doses (0, 6-month schedule) of an inactivated hepatitis A vaccine (Havrix pediatric, Glaxco SmithKline Biologicals, Rixensart, Belgium) in 120 seronegative children aged 12-24 months. RESULTS: Pain at the injection site and irritability were the most frequently reported local and general symptoms, respectively. No serious adverse events related to the study vaccine were reported. One month after the first dose, all but one subject had antibodies against hepatitis A with a GMT of 159 mIU/mL. After the booster dose, all had antibodies with a GMT of 2,939 mIU/mL. CONCLUSIONS: Our data show that the inactivated hepatitis A vaccine was well tolerated by these toddlers and that the vaccine elicits a good immune response.     

Hepatitis B vaccination in Indian children: Seroprotection and age-related change in antibody titres

BackgroundChildhood immunization against hepatitis B is one of the most effective strategies for reducing the global burden of chronic hepatitis B infection and its sequelae. There are limited data from India on both the anti-Hep B antibody titres in children after vaccination and the age-related decline in the titres. This study was planned to estimate the proportion of children in the age group of 1–10 years who develop protective levels of anti-hepatitis B antibodies after childhood vaccination and to examine the change in antibody titres with age in these children.MethodsA hospital-based cross-sectional study was carried out in children admitted to the hospital for various ailments. Basic demographic data, vaccination history and HBsAg status of the mother were recorded. All the enrolled children were evaluated for HBsAg and anti hepatitis B surface antibody (anti-HBS) titres. Institutional ethical clearance was obtained, and informed consent from the parents of the children was taken before drawing samples.ResultsWe found that 68.86% Confidence Interval ((CI): 59.8–76.8%) of the children showed protective antibody titres after vaccination, while 31.14% (CI: 23.1–40.2%) of the children had titres less than 10 IU/L. Although 100% of children in the age group from birth to three years had titres more than 10 IU/L, this percentage showed a decline across the age groups, and 60% of children aged 9–10 years had titres less than 10 IU/L.ConclusionChildhood vaccination against hepatitis B is effective in 68% children, and the antibody levels showed a steady decline with increasing age.     

樟脑气味嗅觉条件刺激诱发小鼠条件反射性抗体增强的实验研究

目的 对流感疫苗(流感病毒血凝素表面抗原)的接种,观察条件反射性免疫反应.方法 采用36只BALB/c小鼠肌肉注射流感疫苗抗原(3 μg/每只动物)为非条件性刺激,与樟脑气味嗅觉条件刺激一次性结合.第6周末再次给予条件刺激,观察条件反射性流感疫苗的抗体反应.结果 条件刺激组在一次性条件刺激后,抗流感疫苗的抗体水平OD值增高(第9周0.68±0.06;第10周0.60±0.06),与非条件刺激组(第9周0.53±0.06;第10周0.48±0.04)比较差异有显著性( P <0.01).与条件训练对照组和非条件训练对照组比较差异有显著性( P <0.05).结论 经过一次樟脑气味嗅觉条件刺激与流感疫苗非条件刺激的结合训练后,单独条件刺激能够诱导动物出现条件反射性抗体增强反应.     

甲乙型肝炎联合疫苗小鼠的免疫原性

目的观察甲乙型肝炎联合疫苗的免疫原性.方法制备甲乙型肝炎联合疫苗,不同配比的甲乙型肝炎联合疫苗于第0、4、24周3次接种小鼠,连续测定甲型和乙型肝炎抗体水平;1次免疫后测定小鼠脾脏单个核细胞增殖情况及CD4 和CD8 细胞数量变化情况.结果3次免疫后,各组甲、乙型肝炎抗体阳转率均达到100%,且联合疫苗组早于单价对照组阳转;所诱导的甲、乙型肝炎抗体水平在数值上超过了单价对照,但无显著差异.1次接种后,联合疫苗能有效诱导机体的细胞免疫应答,小鼠脾脏单个核细胞增殖,CD4 和CD8 细胞数量增加.结论所制备的联合疫苗具有良好的免疫原性.     

Vaccination against hepatitis B infection in patients with end stage renal disease

Background: Experience of hepatitis B vaccination in a contemporary renal replacement programme is reported. Methods: A total of 406 patients were involved: 214 on haemodialysis, 97 on continuous ambulatory peritoneal dialysis, 67 predialysis (serum creatinine >400 µmol/l), and 28 with a failing transplant. Primary vaccination comprised recombinant hepatitis B vaccine (Engerix B) 40 µg intramuscularly at 0, 1, 2, and 3 months. Booster doses were administered three monthly if anti-HBs titre was <100 IU/l. Results: Uptake of vaccine was 61% (haemodialysis 70%, continuous ambulatory peritoneal dialysis 62%, predialysis 31%, transplant 61%, p<0.0001). Primary seroconversion occurred in 64% of vaccinated patients (anti-HBs; 10–100 U/l, 33%; >100 U/l, 31%). Booster doses led to further improvement in immunity in 66/115 (57%) patients after a first and 8/20 (40%) patients after a second booster dose, but uptake was again poor (first booster 74%, second 31%). Seroprotection declined unexpectedly rapidly; after a mean of 16 months 71/115 patients (62 %) had a significant fall in their anti-HBs titres; 30/115 (26%) lost detectable antibody. Conclusions: Routine hepatitis B vaccination of patients with end stage renal failure is logistically difficult to administer on a large scale; primary seroconversion is relatively poor, but improves after repeated booster doses; protective anti-HBs titres decline rapidly, and yearly antibody checks with selective booster doses will be required to maintain seroprotection. The cost effectiveness of a vaccination programme will vary greatly depending on the prevalence of hepatitis B in the population at risk.