一种无细胞百白破联合疫苗的免疫学效果评价

目的：评价长春长生生物科技股份有限公司研制的吸附无细胞百白破联合疫苗（观察疫苗）应用于3～5月龄儿童的免疫原性。方法：在江苏省赣榆县选择3～5月龄未接种过百白破联合疫苗的健康儿童进行现场试验,采用随机、双盲、同类疫苗平行对照设计,将观察对象按3;2的比例随机接受观察疫苗和对照疫苗（武汉生物制品研究所生产）的基础免疫全程接种。在接种前后采集血清样本,采用抗PT-ELISA、抗FHA—ELISA方法分别检测抗百日咳毒素抗体和抗丝状血凝素抗体,采用ELISA方法分别检测抗白喉和破伤风抗体。结果：受试者观察疫苗破伤风、白喉抗毒素阳转率分别为100．00％、98．05％;抗百日咳毒素抗体、抗丝状血凝素抗体阳转率分别为87．99％、93．18％。4种抗体阳转率与对照疫苗差异无显著性（P〉0．05）。观察疫苗免后四种抗体GMT水平分别为4．3985、0．8825、36．0000、43．5000,显著高于免疫前（P〈0．01）。结论：长春长生生物科技股份有限公司研制的吸附无细胞百白破联合疫苗接种后具有良好的免疫原性。     

两种百白破疫苗应用的比较

接种百白破疫苗是预防百日咳、白喉、破伤风等传染病的有效手段，普通的百白破疫苗接种后副反应较多。我院自2003年4月份推广使用由成都生物制品研究所生产的吸附无细胞百白咳、白喉、破伤风联合疫苗(精制百白破)，现将应用这两种疫苗的情况比较如下。     

百白破联合疫苗接种反应观察

吸附百白破联合疫苗(WPDT)在我区广泛应用以来,有效地控制了白喉、百日咳、破伤风的发病。但就接种反应来看,它是计划免疫现用疫苗中接种反应发生率较高的疫苗。为了减少接种反应,我区已开始使用新型制剂吸附无细胞百白破联合疫苗(APDT),并对318例使用两种疫苗后的接种反应进行了观察,现报告如下。 一、材料与方法 1.制剂配方 APDT:百日咳抗原15～18μg     

溧水县儿童百白破疫苗基础免疫效果研究

[目的]观察3月龄儿童百白破疫苗基础免疫效果。[方法]选择未接种过百白破疫苗、未患过相应传染病的3月龄儿童68人,分别在接种百白破疫苗前及接种后1个月采血检测相应抗体。[结果]免疫前儿童百日咳、白喉、破伤风3种抗体阳性率和GMT分别为1.47％和110.31、41.18％和12.02、19.12％和11.46,免疫1个月后,3种抗体阳性率和GMT分别为100％和1250.55、98.5％和164.65、100％和1136.07。[结论]3月龄儿童百白破疫苗基础免疫效果较好。     

百白破联合疫苗接种反应1420名婴儿观察

吸附无细胞百白破联合疫苗（diphtheria，tetanua and acellular aertussis combined vaccine，adsorbed，DTaP）是预防儿童百日咳、白喉和破伤风的替代传统全细胞百白破联合疫苗的新型疫苗。传统疫苗由于使用百日咳全菌体配制，接种后会伴有严重的副反应。为此作者从2004年改用吸附无细胞百白破联合疫苗。为了解该疫苗注射后的反应，接种门诊对接种的儿童采用注射后随访及电话咨询方式调查反应发生情况，现报告如下。     

243名儿童“四苗”接种免疫效果分析

[目的]了解本市城区儿童接种脊髓灰质炎疫苗、麻疹疫苗、百白破疫苗、乙肝疫苗的免疫效果。[方法]于2007年6月至2009年10月用ELISA法对本市城区243名接种完18月龄百白破疫苗和麻疹疫苗1月后至2岁以内的儿童进行相关6种抗体的检测。[结果]抗体阳性率,脊灰93．83％、麻疹95．06％、百日咳97．94％、白喉96．29％、破伤风98．35％、乙肝68．72％;不同性别间6种抗体阳性率的差异均无统计学意义（P〉0．05）。[结论]脊髓灰质炎疫苗、麻疹疫苗、百白破疫苗接种的免疫效果良好,乙肝疫苗的免疫效果较差。     

常山县2008年百日咳、白喉、破伤风免疫成功率监测

百白破联合疫苗自（DPT）纳入免疫规划以后，百日咳、白喉、新生儿破伤风的发病率大大降低。为评价吸附百日咳、白喉、破伤风联合疫苗及其接种的质量和效果，我县在2008年进行了百日咳、白喉、破伤风免疫成功率监测，本文就2008年监测资料分析如下。     

两种百白破疫苗接种反应和免疫效果观察

吸附百白破三联疫苗 (下简称 WDPT)是由百日咳全菌体疫苗原液和精制白喉、破伤风类毒素用氢氧化铝吸附制成 ,而吸附无细胞百白破三联疫苗 (下简称 ADPT)是由无细胞百日咳疫苗原液取代上述百日咳全菌体疫苗制成的疫苗。为比较上述两种疫苗接种反应和免疫效果 ,于 2 0 0 1年 10月～ 2 0 0 2年 7月在免疫接种门诊选择 4 6 0名婴幼儿进行了分组观察 ,现将结果报告如下。1　材料与方法1.1　疫苗与接种　 WDPT是武汉生物制品研究所生产 ,批号为 2 0 0 10 4 10 - 1;ADPT是成都生物制品研究所生产 ,批号为 2 0 0 10 812 - 6。接种时每人份剂…     

百日咳和白喉胎传抗体监测分析

目的开展百日咳和白喉胎传抗体及百白破疫苗接种的免疫成功率监测,为百日咳和白喉预防接种策略的调整提供科学依据。方法选择2013年1月-2月在天津市滨海新区出生并计划将长期居住的132名新生儿,开展胎传抗体及其衰减情况以及百白破疫苗免疫成功率监测。采集脐带血,监测新生儿百日咳Ig G抗体和白喉Ig G抗体及其衰减情况;采集静脉血,监测新生儿接种完3剂百白破疫苗后,间隔1个月百日咳Ig G抗体和白喉Ig G抗体水平。结果百日咳、白喉胎传抗体阳性率分别为31.06%、33.33%;3月龄时百日咳、白喉胎传抗体的转阴率分别为89.19%、94.59%;接种3针百白破疫苗后1个月,百日咳、白喉的免疫成功率分别为76.67%、100.00%。结论百日咳和白喉胎传抗体阳性率低并且转阴快,3月龄前婴儿感染百日咳风险很高;百日咳基础免疫后免疫成功率相对较低。     

2001年柳州市儿童乙肝、麻疹、白喉抗体水平检测

目的 对柳州市儿童乙型肝炎疫苗、麻疹疫苗、百白破疫苗免疫后抗体水平监测。方法 随机抽取已全程接种过乙肝、麻疹、百白破疫苗适龄儿童2353人，采用酶联免疫吸附试验(ELISE)检测血清中的乙肝表面抗体和麻疹IgG抗体；采用锡克氏试验检测白喉。结果 乙肝抗体阳转率为69．87％，麻疹抗体阳转率为87．59％，白喉锡克氏试验阴性率为98．47％。结论 柳州市儿童麻疹、百白破疫苗免疫后抗体水平较高，乙肝疫苗免疫后抗体水平较低。     

Immunogenicity and reactogenicity of acellular diphtheria/tetanus/pertussis vaccines given as a pre-school booster: effect of simultaneous administration of MMR.

Four acellular diphtheria/tetanus/pertussis (aDTP) vaccines were compared with two diphtheria/tetanus (DT) vaccines given as a pre-school booster to 1033 children aged 4 to < 6 years who had completed primary immunisation with DTP vaccine according to the UK 2, 3 and 4 month schedule; 71 children had received aDTP vaccine and the remaining 962 a whole cell DTP vaccine for primary immunisation. The effect of simultaneous administration of a second dose of MMR vaccine was evaluated in 374 (37%). Overall, there was little difference in the frequency of post-vaccination symptoms in DT and aDTP vaccinees, although local reactions occurred more quickly in the aDTP group. The concomitant administration of MMR had no effect on local reactions or fever within 10 days, or on the proportions requiring a doctor's visit in the 4--6 week post-vaccination period. Local reactions > or = 3 cm were higher on day 2 in children who had received aDTP for primary immunisation (erythema 32.4% vs. 17.4% for wDTP, P = 0.0012; swelling 28.2% vs. 15.5%, P = 0.0027). Pertussis antibody responses were consistent with the antigen content of the aDTP vaccines. All were more immunogenic with respect to PT -- the only pertussis antigen which by itself has been shown to be protective in clinical trials -- than a wDTP pre-school booster given in an earlier trial. MMR vaccine had no significant effect on antibody responses to either the pertussis or diphtheria and tetanus antigens. Diphtheria antibody responses in children who had received wDTP for primary immunisation were 2.8 times higher than in those who had received aDTP vaccine (P < 0.0001); they were also higher in children who had received a single dose of a Haemophilus influenzae type b vaccine containing CRM(197) conjugate after 12 months of age. For countries currently using DT vaccines as a pre-school booster, replacement with an aDTP vaccine is unlikely to have a perceptible effect on reactogenicity, at least in children given wDTP for primary immunisation, and would boost antibody levels to antigens known to be associated with protection.     

不同剂量国产重组酵母乙肝疫苗成人免疫效果评价

目的评价lO／μg和20／μg国产重组酵母（CHO）乙型肝炎（乙肝）疫苗成年人的免疫效果。方法在北京市昌平区选取两个自然村,选择18～45岁未接种乙肝疫苗、乙肝五项指标均为阴性的222名成年人作为研究对象,随机分为两组,双盲对照,按照“0-1－6”程序分别接种10／μg和20μg CHO乙肝疫苗。通过问卷方法调查每个对象可能影响乙肝疫苗免疫效果的个体因素。于接种第三针1个月后采血,以化学发光方法检测抗－HBs滴度值,抗－HBs阴性者采用荧光定量PCR方法进一步检测HBVDNA。结果10μg和20ptg两个剂量组抗HBs阳转率分别为89．47％（95％CI：83．75％～95．19％）和99．07％（95％CI：97．24％～100．00％）,抗体几何平均滴度（GMT）分别为134．57IU／L和921．11Iu／L,差异有统计学意义（P值分别为0．02和0．00）。结论CHO乙肝疫苗有较好的安全性和免疫原性,20μg是成人免疫的最佳剂量。     

健康人群乙型肝炎疫苗再免疫抗体应答

目的探讨不同年龄组健康人群接种不同类型、不同剂量乙型肝炎（乙肝）疫苗（Hepatitis B Vaccine,HepB）的再免疫抗体应答。方法采用分层随机抽样方法,按地域分布选取东莞市5个镇2～4、6～8、13～15、16～40岁4个年龄组健康人群,用酶联免疫吸附试验筛查乙肝病毒核心抗体、乙肝病毒表面抗原和乙肝病毒表面抗体均为阴性,且有3剂HepB免疫史的人作为再免疫研究对象。采用5μg重组HepB（酵母）（HepB Made by Recombinant DNA Techniques in Yeast,HepB-Y）、10μg HepB-Y、10μg重组HepB（中国仓鼠卵巢细胞）（HepB Made by Recombinant DNA Techniques in CHO Cell,HepB-CHO）、10μg重组HepB（汉逊酵母）（HepB Made by Recombinant DNA Techniques in Hansenula Yeast,HepB-HY）、20μg HepB-CHO和20μg HepB-Y,均按0、1、6个月程序再免疫3剂。结果不同类型不同剂量HepB在人群中的再免疫成功率和抗体水平中位数[毫国际单位/毫升（mIU/ml）]分别为：5μg HepB-Y94.34%和226.53,10μg HepB-Y86.46%和175.36,10μg HepB-CHO97.39%和331.44,10μg HepB-HY91.30%和439.01,20μg HepB-CHO99.20%和386.66,20μg HepB-Y89.04%和372.97。各年龄组的再免疫成功率和抗体水平中位数（mIU/ml）分别是：2～4岁98.25%和353.42,6～8岁96.80%和320.31,13～15岁94.67%和282.12,16～40岁87.76%和305.24。结论年龄、疫苗种类和剂量是影响再免疫抗体应答的主要因素,随年龄的增长再免疫抗体应答下降,更换疫苗种类可提高再免疫抗体应答。     

Efficacy of a mass hepatitis B immunization program after switching to recombinant hepatitis B vaccine: a population-based study in Taiwan

To study the efficacy of immunization against hepatitis B after plasma-derived vaccine was replaced by recombinant vaccine, 2-year-old Taiwanese children were recruited by stratification random sampling and tested for hepatitis B markers. They were grouped according to maternal infectivity and children's immunization status. Of 2010 children, 2.5% had hepatitis B surface antigen (HBsAg), 94.1% had its antibody (anti-HBs), 6.8% had core antibody, and 3.3% were seronegative. Children of highly infectious mothers immunized with hepatitis B immunoglobulin and vaccine on schedule had a lower HBsAg-positive rate and a higher anti-HBs-positive rate than those with vaccine only and off-schedule. The efficacy of the Taiwanese mass hepatitis B immunization was maintained after switching to recombinant hepatitis B vaccine.     

Elevated levels of maternal anti-tetanus toxin antibodies do not suppress the immune response to a Haemophilus influenzae type b polyribosylphosphate-tetanus toxoid conjugate vaccine

Reported are the effects of elevated levels of anti-tetanus antibodies on the safety and immune response to a Haemophilus influenzae type b polyribosylphosphate (PRP)-tetanus toxoid conjugate (PRP-T) vaccine. A group of Thai infants (n = 177) born to women immunized against tetanus during pregnancy were vaccinated with either a combined diphtheria-tetanus-pertussis (DTP) PRP-T vaccine or DTP and a PRP-conjugate vaccine using Neisseria meningitidis group B outer-membrane proteins as a carrier (PedVax HIB). Although most infants possessed high titres (> 1 IU/ml) of anti-tetanus antibodies, the DTP-PRP-T combined vaccine engendered an excellent antibody response to all vaccine components. In both vaccine groups > 98% of infants attained anti-PRP antibody titres > or = 0.15 microgram/ml. The geometric mean anti-PRP antibody titres were 5.41 micrograms/ml and 2.1 micrograms/ml for infants immunized with three doses of PRP-T versus two doses of PedVax HIB vaccines, respectively (P < 0.005). Similarly, the proportion of infants who achieved titres > or = 1 microgram/ml was higher in the PRP-T group (87.8%) than in the group immunized with PedVax HIB (74.2%) (P = 0.036). A subgroup analysis showed that there was no significant difference in the anti-PRP antibody response for infants exhibiting either < 1 IU of anti-tetanus antibody per millilitre or > or = 1 IU/ml at baseline. These finding indicate that pre-existing anti-carrier antibody does not diminish the immune response to the PRP moiety. All infants possessed protective levels of anti-D and anti-T antibody levels after immunization.     

健康人群中乙肝疫苗无（低）应答者再免疫效果研究

目的探讨不同年龄段健康人群中乙肝疫苗免疫后无（低）应答者接种不同类型乙肝疫苗的再免疫效果。方法采用分层随机抽样方法，按地域分布选取东莞市五镇区2～4岁、6～8岁、13～15岁和16～40岁四个年龄组健康人群，用ELISA法筛查HBcAb、HBsAg、HBsAb均为阴性且有3针乙肝疫苗免疫史的人员作为再免疫研究对象。采用5μg酵母、10μg酵母、10μgCHO、10μg汉逊酵母、20μgCHO和20μg酵母乙肝疫苗按0、1、6月程序再免疫3剂。结果各种疫苗在人群中的再免疫成功率和抗体水平中位数（mIU／m1）分别为：5μg酵母94．34％和226．53，10μg酵母86．46％和175．36，10μgCHO97．39％和331．44，10μg汉逊酵母91．30％和439．01，20μgCHO99．20％和386．66，20μg酵母89．04％和372．97。各年龄组的再免疫成功率和抗体水平中位数（mIU／m1）分别是：2～4岁组98．25％和353．42，6～8岁组96．80％和320．31，13～15岁组94．67％和262．12，16～40岁组87．76％和305．24。结论年龄、疫苗种类和接种剂量是影响无（低）应答者再免疫效果的主要因素，随年龄的增长再免疫效果下降，更换疫苗种类可提高再免疫效果。     

Antibody level of New Zealand children immunized with the triple vaccine DTP (diphtheria-tetanus-pertussis)

Enzyme-linked immunosorbent assay (ELISA) tests were used to measure IgG antibody levels in 2638 New Zealand children who had been immunized with the triple vaccine DTP. The percentage of children immune to diphtheria decreased with age. The percentage of children immune to tetanus varied from 67.1 to 55.0%. The percentage of children with measurable antibody to pertussis increased with age. The mean percentages of children with measurable antibody or immunity to one or more DTP components were 34.2% (with 3 components), 34.4% (2 components), and 78.1% (1 component). It appears the immunization strategy for diphtheria and tetanus is satisfactory for herd immunity in New Zealand children. However, the current pertussis strategy may not be providing adequate immunity to 5-year-olds in this country.     

Safety and immunogenicity of combined diphtheria-tetanus-pertussis (whole cell and acellular)-Haemophilus influenzae-b conjugate vaccines administered to Indonesian children

A randomized double-blind trial was conducted to evaluate the safety and immunogenicity of vaccines comprised of diphtheria (D) and tetanus (T) toxoids combined with either a whole cell (P) or an acellular (aP) pertussis component and Haemophilus influenzae type b polyribosylphosphate (PRP) tetanus toxoid conjugate (PRP-T) in Indonesian infants. Three doses of either DTaP, DTaP-PRP-T, or DTP-PRP-T were administered to 930 infants approximately 2-3 months of age and at 2 month intervals thereafter. A booster dose of either DTP-PRP-T or DTaP-PRP-T was administered at 15-18 months of age. Both local and systemic reactions occurred at a significantly (p < 0.001-0.026) higher rate in the group that received whole cell pertussis vaccine versus groups which were immunized with aP containing vaccines. There was no significant difference (p > 0.05) in the rate of adverse events between groups immunized with DTaP or DTaP PRP T. One month after the third dose of vaccine, 99% of subjects had achieved > or =0.1 IU of anti-D and anti-T antibody per ml of serum. The geometric mean titer (GMT) to D was significantly (p < 0.001) higher in the group immunized with DTaP versus the other two groups whereas the anti-T GMT was significantly (p < 0.006) higher for the group immunized with DTP-PRP-T. Both the anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibody levels were significantly (p < 0.001) higher in recipients of acellular versus whole cell pertussis vaccine. In contrast, the anti-B. pertussis agglutinating antibody response was significantly (p < 0.0001) higher in the group immunized with whole cell pertussis vaccine. The anti-PRP GMTs (microg antibody/ml) at 7 months were 0.096, 3.35 and 6.11 for groups immunized with DTaP, DTaP-PRP-T and DTP-PRP-T, respectively. The GMT for those immunized with DTP-PRP-T was significantly (p < 0.001) higher compared to recipients of DTaP-PRP-T. The percent of children who attained > or =0.15 or > or =1 microg/ml after immunization was 18 and 2% for the DTaP group, 93 and 76% for the DTaP-PRP-T group and 97 and 88% for the DTP-PRP-T group. At the > or =1 microg/ml level the difference between the DTaP-PRP0-T and DTP-PRP-T groups was significant (p < 0.01). Children immunized with either DTaP, DTaP-PRP-T, or DTP-PRP-T were reimmunized with DTaP-PRP-T whereas a portion of children immunized with DTP PRP T where also boosted with this vaccine at 15-18 months of age. There was a vigorous anamnestic response to the D and T components with all children possessing > or =0.1 IU/ml. There was also a substantial increase in anti-PT, anti-FHA and B. pertussis agglutinating antibodies. The poorest anti-PT response was seen among children receiving DTP-PRP-T for both primary and reimmunization while the highest agglutinating antibody response followed receipt of 4 doses of DTP-PRP-T. Greater than 80% of children immunized with either DTP PRP T or DTaP-PRP-T possessed > or =0.15 microg/ml before boosting versus 38% for those vaccinated with DTaP (p < 0.001). Primary immunization with DTP-PRP-T resulted in a significantly (p < 0.05) higher percentage (72%) maintaining > or =1 microg/ml compared to those immunized with DTaP-PRP-T (46%). Prior to reimmunization, the anti-PRP GMT was significantly (p < 0.005) higher for children immunized with 3 doses of DTP-PRP-T versus DTaP-PRP-T. Subsequent to reimmunization, > or =95% of subjects attained > or =1 microg/ml.     

Impact of the sequential poliovirus immunization schedule: a demonstration project

OBJECTIVE: Researchers for this project evaluated compliance with the sequential poliovirus immunization schedule that uses inactivated poliovirus vaccine (IPV) for the first 2 doses of the polio immunization series, and assessed immunization coverage rates before and after implementation of this schedule at 6 public health clinics serving 1 county in Georgia. DESIGN: Immunization histories for 3 birth cohorts of infants were compared: (1) the baseline cohort, born January 1 through June 30, 1995; (2) the evaluation cohort, born January 1 through June 30, 1997, after implementation of the schedule change; and (3) the dose-3 cohort, born August 1 through November 30, 1996 (i.e., old enough to be eligible for a third dose of poliovirus vaccine following implementation of the sequential schedule). RESULTS: Following implementation of the new poliovirus immunization recommendations, 94% (534 of 567) of infants who received their first dose of poliovirus vaccine by age 3 months received IPV. Among these infants, 99.6% (532 of 534) were also up to date (UTD) for first doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTP1/DTaP1), 99.6% (532 of 534) were UTD for first doses of hemophilus influenza type b (Hib 1), and 98.6% (527 of 534) had received at least one dose of Hepatitis B. Among infants visiting the clinics for their first or second dose of poliovirus vaccine, DTaP/DTP, and/or Hib, 76% received 3 or 4 simultaneous injections. In the dose-3 cohort, 78% (145 of 185) of infants who received a third dose of poliovirus vaccine had received 2 doses of IPV and 1 dose of oral poliovirus vaccine. CONCLUSIONS: Compliance with the recommended use of IPV for the first 2 poliovirus immunization doses as part of the sequential schedule was very high in this low-income and ethnically diverse population. Furthermore, the need for additional injections did not impede the delivery of recommended childhood immunizations.     

Rapid and frequent induction of protective immunity exceeding UK recommendations for healthcare settings by MF59-adjuvated hepatitis B vaccine

The ability of three doses of a novel MF59-adjuvanted hepatitis B virus (HBV) vaccine containing surface and pre-S2 antigens given at 0, 1, and 6 months to induce levels of HBV surface antibody (sAb) > or = 100 mIU/ml was compared with a UK licensed alum-adjuvanted yeast-derived HBV vaccine in HBV-naive healthcare workers (HCWs). One month after second immunization with HBV/MF59, 100% of HCWs had sAb > or = 100 mIU/mL, compared with only 11% and 85% after two or three immunisations with Engerix-B. The sAb GMT of the Engerix B immunised group remained below 100 mIU/mL until month seven, (compared with month one for HBV/MF59), and was 123-fold lower at this time (208,561 vs. 1,686 mIU/mL). In our subjects HBV/MF59 vaccine rapidly induced sAb to levels far in excess of those recommended by the Department of Health for high-risk situations (e.g. HCWs and patients on dialysis). It has the potential for shorter schedules and reduced need for serology and boosters.