不同剂量国产重组酵母乙型肝炎疫苗成年人免疫效果及影响因素研究

Objective To evaluate the immuno-effect and related influencing factors on 10 μg and 20 μg Chinese hamster ovary (CHO) cell hepatitis B vaccine, using the randomized double-blind controlled trials in adult population. Methods A total of 642 adults aged 18-45 years old, non-vaccinated against hepatitis B, and negative on five blood indicators for hepatitis B, were selected as the study objects from four districts in Beijing. The study objects were randomly divided into two groups, and then accepted 10 tg and 20 μg recombinant CHO hepatitis B vaccination by 0-1-6 month schedule. Influencing factors were investigated by means of questionnaire. Blood samples were collected one month after the third dose of vaccination. Anti-HBs level was detected by Abott chemiluminescence detection method. For the anti-HBs negative person, fluorescent quantitative PCR method was used to find out if the person had been infected with HBV. Logistic regression analysis was used to find out the influencing factors of anti-HBs seroconversion on every studied subject. Results The anti-HBs seroconversion rates on 10 μg and 20 μg dose groups were 88.8%(95%CI: 85.4%-92.2%) and 95.3%(95%CI: 93.0%-97.6%)respectively. Taking the anti-HBs level＜100 mIU/ml as the low/non-response standard, the low response and non-response rates were 34.3% and 17.4% respectively. The geometric mean titers(GMT)of anti-HBs were 173.42 mIU/ml for the 10 μg dose group and 588.51 mIU/ml for the 20 μg dose group. Data from the Multivariate analysis showed that: diabetes, spouses infected with hepatitis B virus and old age were unfavorable factors for anti-HBs Seroconversion. 20 μg dose of the vaccine was conducive to seroconversion.Conclusion 20 μg CHO hepatitis B vaccine seemed better than 10 μg CHO hepatitis B vaccine while many factors need to be taken into account for evaluation on hepatitis B vaccines.     

不同剂量国产重组酵母乙型肝炎疫苗成年人免疫效果及影响因素研究

Objective To evaluate the immuno-effect and related influencing factors on 10 μg and 20 μg Chinese hamster ovary (CHO) cell hepatitis B vaccine, using the randomized double-blind controlled trials in adult population. Methods A total of 642 adults aged 18-45 years old, non-vaccinated against hepatitis B, and negative on five blood indicators for hepatitis B, were selected as the study objects from four districts in Beijing. The study objects were randomly divided into two groups, and then accepted 10 tg and 20 μg recombinant CHO hepatitis B vaccination by 0-1-6 month schedule. Influencing factors were investigated by means of questionnaire. Blood samples were collected one month after the third dose of vaccination. Anti-HBs level was detected by Abott chemiluminescence detection method. For the anti-HBs negative person, fluorescent quantitative PCR method was used to find out if the person had been infected with HBV. Logistic regression analysis was used to find out the influencing factors of anti-HBs seroconversion on every studied subject. Results The anti-HBs seroconversion rates on 10 μg and 20 μg dose groups were 88.8%(95%CI: 85.4%-92.2%) and 95.3%(95%CI: 93.0%-97.6%)respectively. Taking the anti-HBs level＜100 mIU/ml as the low/non-response standard, the low response and non-response rates were 34.3% and 17.4% respectively. The geometric mean titers(GMT)of anti-HBs were 173.42 mIU/ml for the 10 μg dose group and 588.51 mIU/ml for the 20 μg dose group. Data from the Multivariate analysis showed that: diabetes, spouses infected with hepatitis B virus and old age were unfavorable factors for anti-HBs Seroconversion. 20 μg dose of the vaccine was conducive to seroconversion.Conclusion 20 μg CHO hepatitis B vaccine seemed better than 10 μg CHO hepatitis B vaccine while many factors need to be taken into account for evaluation on hepatitis B vaccines.     

The immunogenicity and safety of 10 μg recombination yeast hepatitis B vaccine applied in expanded population

Objective To assess the feasibility of the 10 μg recombination yeast hepatitis B vaccine in the expanded applicable population group aged 5-18. Methods People with both HBsAg and anti-HBs negative were selected to take two-stage clinical experiment and the safety and immunogenicity were observed. Safety observation was conducted in 925 subjects, while 568 for immunogenicity. The observation group (aged 5-18) included 493 subjects, and (age>18) 75 enrolled in control group. For the observation group,there were three sub-groups including a child group (141, aged 5-6), early youth group(177, aged 12-13), and youth group (175, aged 16-18). Both groups were administered with 10 μg recombination yeast hepatitis B vaccines with 3 doses at 0 month, 1st month,6th month. To assess the immunogenicity,the vaccination reactions were observed during the following 4 weeks in order to assess the vaccine safety. The blood samples were taken during 4-6 weeks after fully vaccinated, and then anti-HBs were tested with RIA and analyzed by comparing the positive rate of anti-HBs,the geometric mean titer(GMT) and the protective rate between the two groups. Results Both observation and control group didn't show any general reactions,adverse events following immunization(AEFI) or coincidental cases when observed at 0. 5 h,6 h,24 h,48 h, 72 h, 1 week,2 weeks,3 weeks,4 weeks after being vaccinated. The result of serum test showed, the positive rates of child group, early youth group, youth group and control group were respectively 100. 00% (141/ 141),97.18% (172/177), 98. 29% (172/175) and 89. 33% (67/75); the GMTs of anti-HBs were respectively 440. 28,875.38,467.80,131.06 U/L; the protective rates were respectively 100. 00% (141/ 141), 97.18%(172/177), 97.14% (170/175) and 86. 67% (65/75). The positive rate, GMT and protective rate of the experimental group were all higher than that of control group(χ2<,positive rate>=12.77,5.12, 7.99; tGMT=3.89,4.13,5.91;χ2protective rate>=16. 81,8.60,8.44;P< 0.05). Conclusion This vaccine could be expanded to 5-18 year-old population with safety and effectiveness, the positive rate and protective rate of anti-HBs were both higher than that of control group.     

补充维生素A对婴幼儿乙肝疫苗再免疫效果的促进作用

目的 观察补充维生素A(VA)对婴幼儿乙型病毒性肝炎(简称乙肝)疫苗再免疫效果的影响.方法 于2008年10月至2009年3月间,招募山东临沂某农村地区所有按国家计划免疫常规全程接种过乙肝疫苗的7～36月龄婴幼儿,检测其血清乙肝表面抗体(抗-HBs)浓度,对其中100名血清抗-HBs水平较低的婴幼儿进行随机(随机数字表法)、双盲、安慰剂对照的VA干预实验.干预组(50名)采用市售浓缩鱼肝油作为VA补充剂,补充期3个月,每15天补充1次,每次0.5 g浓缩鱼肝油[含25 000 IU VA和2500 IU维生素D2(VD2)],共补充6次;对照组(50名)给予等体积玉米油.在干预实验开始后第30和第60天,给婴幼儿进行乙肝疫苗再免疫接种,第90天采集婴幼儿血清样本.用高效液相色谱法(HPLC)测定干预实验前后婴幼儿血清视黄醇浓度.用电化学发光免疫分析法(ECLIA)测定血清抗-HBs水平.结果 共有74名婴幼儿完成干预实验,实验组和对照组各37名.干预后,干预组和对照组儿童的血清视黄醇浓度分别为(404.1±123.1)、(240.8±92.8)μg/L(t=6.441,P＜0.01);两组儿童的血清抗-HBs水平分别为(2737.2±2492.6)和(1199.7±2141.6)U/L(t=2.846,P＜0.01).干预组无乙肝疫苗弱、无应答情况(0/37),对照组乙肝疫苗弱、无应答率为10.81%(4/37)(x2=4.229,P=0.040).结论 补充VA可提高儿童乙肝疫苗再免疫后血清抗-HBs水平.

Abstract：

Objective The objective of this study was to observe the interventional effect of cod liver oil supplementation on re-vaccination to hepatitis B virus (HBV) among infants and young children. Methods All 7 -36 months old infants and young children, who had been vaccinated with obligatory HBV vaccines routinely by the national technical and administrative procedures for HBV vaccination on children of China, were convened among villages in Linyi, Shandong province, from October 2008 to March 2009. After detection of serum anti-HBV, one hundred children with lower serum anti-HBV were picked out for the randomized, double blinded, placebo controlled vitamin A supplementation study. The children in the intervention group (50 subjects) took 0. 5 g condensed cod liver oil ( containing 25 000 IU vitamin A and 2500 IU vitamin D2 ) every 15 days for six times. The children in the control group (50 subjects) were given corn oil with same volume. All children were re-vaccinated at the 30th and the 60th day of the experiment. The serum samples were collected from each child at the 90th day of the experiment. Retinol concentration in serum samples was analyzed with HPLC method before and after the intervention. The levels of serum anti-HBs were detected by the electro-chemi-luminescence immunoassay (ECLIA) .Results Total 74 children finished the supplemental experiment and blood collection,37 subjects in each group, respectively. After intervention, the serum retinol level in the experimental and control group were ( 404. 1 ± 123. 1 ) and ( 240. 8 ± 92. 8 ) μg/L ( t = 6. 441, P ＜ 0. 01 ), respectively. The serum anti-HBs levels in the experimental and control group were( 2737.2 ± 2492.6 )and( 1199. 7 ± 2141.6 )U/L ( t =2. 846, P ＜ 0. 01 ), respectively. The rate of weak or no-answer case in experimental and control groups was 0. 00% ( 0/37 ) and 10. 81% ( 4/37 ) ( x2 = 4. 229, P = 0. 040), respectively. Conclusion The results showed that vitamin A supplementation might enhance the re-vaccination reaction against HB vaccine in infants and young children.     

慢性乙型肝炎患者配偶乙型肝炎病毒感染状况调查和分析

Objective To evaluate the influence of daily contact on HBV infection between hepatitis B virus carriers and their spouses by investigating the infection situation after marriage. Methods Premarital HBV carriers of serum HBV DNA positive were enrolled, family history, the histoty of blood donation, blood transfusion, drug abuse,physical examination, premarriage medical check, extramarital sex and hepatitis B vaccine were investigated in their spouses. Couples who were infected before marriage or vaccined with HBV vaccine were excluded. 68 couples were enrolled with an average marriage time of 12.5 years (0.5-35 years), their HBV serum markers and quantitative were performed. Results In the 68 couples, 54(79.4%) spouses were serum HBV marker positive, of the 54 spouses, 4 were HBV DNA positive. The chronic rate of HBV infection in the spouses was 7.4%, and was similar to the rate in general population(5%-10%). 48(88.9%) spouses were anti-HBs positive, the positive rate was similar to the rate in vaccinated population (85%-90%). Male spouses with at least one HBV marker positive were 22 cases (22/24), occupied 91.7% , female spouses were 32(32/44), occupied 72.7%, there was no difference between the male and female spouses(χ2 = 2.681, P > 0.05). Conclusions Whether HBV carriers' spouse infected with HBV is not correlated with marriage time, gender and HBV DNA level of carriers. HBV infection rate of the healthy people increases after marriage with HBV carriers, but the rate of chronic HBV infection is not increased obviouly.     

血清降钙素原在社区获得性肺炎诊断与病情判断中的价值

Objective To estimate the influence of abnormal glucose metabolism during pregnancy and family history of cardio-cerebrovascular disease and/or diabetes on umbilical C-peptide concentrations. Methods Chesed 85 pregnant women who had prenatal examination and their newborns as the subjects. Thirty-six newborns of mothers with gestational diabetes mellitus, impaired glucose tolerance or diabetes mellitus with pregnancy and 49 newborns of mothers with normal glucose tolerance were randomly chosed as the control group. All newborns were also classified according to whether their maternal grandparents had history of diabetes and/or cardio-cerebrovaacular disease. Therefore, there were four groups in this study: 25 newborns in group A were of diabetic mothers and positive family history, 11 newborns in group B were of diabetic mothers but negative family history, 9 newborns in group C were of mothers with normal glucose tolerance but positive family history, 40 newborns in group D were of mothers with normal glucose tolerance and negative family history. The blood samples of umbilical veins were collected at the time of delivery. Umbilical C-peptide levels of the four groups were measured by radioimmunonssay. Results The umbilical C-peptide concentrations of newborns in group A, B, C, D were (2.22±1.52), (1.44±0.63), (1.13± 0.34), (1.31±0.69) μg/L respectively, the umbilical C-peptide concentrations of newborns in group A were elevated compared to those of other three groups (F=5.11, P=0.003), and there were no significant differences in C-peptide levels of newborns between the three groups (group B vs C P=0.499, group B vs D P=0.694, group C vs D P=0.642). Conclusion Special attention should be given to newborns of diabetic mothers and whose maternal grandparents have history of diabetes and/or cardio-cerebrovascular disease.     

抗-HBs衰减青少年乙肝疫苗加强免疫效果研究

目的研究乙肝疫苗(Hepatitis B Vaccine,HepB)基础免疫后12～15年乙肝病毒表面抗原抗体(抗-HBs)衰减者加强免疫前后抗体水平间的关系,比较不同剂次的加强免疫效果。方法选择婴儿期完成HepB基础免疫的1993—1997年出生的儿童,采集静脉血,使用化学发光法检测后,HBsAg及抗-HBc阴性而抗-HBs降至保护性水平(10mIU/ml)以下作为研究对象。按抗-HBs滴度水平分为3组:Ⅰ组(﹤0.1 mIU/ml)、Ⅱ组(0.1～1 mIU/ml)和Ⅲ组(﹥1 mIU/ml);按0、1、6免疫程序加强免疫3剂10μg的重组乙肝疫苗(汉逊酵母)(HepB-HPY),分别于免疫1剂和3剂后1个月采集静脉血,检测抗-HBs。结果 453名研究对象加强免疫1剂后各组抗-HBs阳转率分别为67.96%、85.61%和97.60%,抗体滴度分布差异有统计学意义(χ2=132.88,P﹤0.05),几何平均浓度(GMC)分别为37.31、152.77和1310.27 mIU/ml(F=86.11,P﹤0.05);加强免疫3剂后各组抗-HBs阳转率分别为99.00%、99.21%和99.49%(Fisher确切概率法,P﹤0.05),GMC分别为1714.67、1502.32和3383.68 mIU/ml(F=16.59,P﹤0.05)。全程采血的425名儿童在免疫1剂和3剂后抗体阳转率分别为87.76%和99.29%(χ2=46.68,P﹤0.05)。结论对于完成HepB基础免疫后抗体衰减至10 mIU/ml以下的12～15岁儿童有必要进行加强免疫,加强免疫前抗体滴度较高者加强免疫效果较好;加强免疫3剂比1剂效果好。     

Study on the incidence of β-Thalassemia and genotypes among children under 7 year-olds in Nanning, Liuzhou and Baise areas, Guangxi province

Objective To conduct research of β-Thalassemia incidence and genotypes on children below 7 years of age in Nanning, Liuzhou and Baise areas, Guangxi province. Methods A total of 2261 children aged below 7 in Nanning, Liuzhou and Baise areas were studied. Venous blood was detected by routine blood test, hemoglobin analysis and β-Thalassemia genotyping. Results Among 2261 samples, 125 showed high level of HbA2 and were diagnosed as β-Thalassemia (5.53%). Genotypes of the patients were classified as: 59 cases with β-globin gene eondon (CD) 41-42 mutation, 33 cases CD17 mutation, 18 cases with TA TA box nt-28 mutation, 7 with IVS-Ⅱ-654 mutation, 3 with CD43 mutation, 3 with HbE mutation, one with CD71-72 and TATA box nt-29 mutation, respectively. The genotyping frequencies of β-Thalassemia were as follows: 47.20% for CD41-42 mutation, 26.40% for CD17 mutation, 14.40% for TATAbox nt-28 mutation, 5.60% for IVS-Ⅱ -654 mutation, 2.40% for CD43 mutation, 2.40% for HbE mutation, 0.80% for CD71-72 mutation and TATAbox nt-29 mutation respectively. Conclusion This study on children in the area with high incidence of β-Thalassemia reflected the incidence and characteristics of genotypes in this area. Our data also provided evidence for the development of a program on genetic counseling and prevention for thalassemia.     

70例手足口病病原检测和临床分析

Objective To analyze the etiology and clinical manifestations of 70 patients with hand-foot-mouth disease (HFMD). Methods The viral RNA from the pharynx swab samples were extracted and collected from 70 HFMD patients (of which,60 cases were under 5 years old) to detect the 5'-UTR gene of EV,the Vp3-Vp1 genes of EV71 and Cox-A16 by utilizing the technique of RT-PCR. Results Of 70 HFMD patients,30 cases (42.8%, 30/70) were positive in enterovirus nucleic acid, including EV71 and Cox-A16,pharynx swab sample testing. While, of the enteroviral pathogen RNA-positive 30 cases, EV71 accounted for 66. 7% (20/30). The proportion of etiological positive of 39 samples collected within 4 days after onset was 66.7% (26/39), but the probability of 31 samples collected after more than 5 days after onset was 12.9%(4/31),the difference was significantly(χ2=20.4,P<0. 01). Conclusion HFMD patients were mainly infants and young children between 0-5 years old, but adults could also be attacked. The enterovirus detected was mainly EV71,and the pharynx swab samples should be collected within 4 days after onset to increase the related viral nucleic acid positive detection probability.     

热性惊厥患儿血清褪黑素水平和细胞免疫功能的变化及其临床意义

Objective To investigate the changes of melatonin and cellular immunological function in children with febrile seizures and its clinical significance. Methods 50 children, including 23 cases with complex febrile seizure (CFS) and 27 cases with simple febrile seizure (SFS) , and 25 cases with upper respiratory infections children selected as control group were enrolled in this study. Serum melato- nin was measured by enzyme-linked immunosorbent assay (ELISA) and cellular immunological function was measured by flow eytomcter. Results The levels of serum melatonin in the 3 groups of CFS, SFS, control were(14. 91±2. 61) ng/L, (20. 72±2. 54) ng/L, (23.93± 2. Ol) ng/L, respectively. The melatonin levels in CFS children were significantly decreased than that in control group and SFS children (P <0. O1). CD3 + ,CD4 +, the ratio of CD4 + /CD8 + and CD8 + in CFS group were significantly decreased than that in control group and SFS group (P <0.01). The ratio of CD4 +/CD8 + in SFS group was significantly decreased than that in control group (P <0.05), but CD3 + ,CD4 + and CD8 + had no statistics significance among these groups(P >0. 05). The serum rnelatonin level were positive related withdecreaseddegreeofCD3+,CD4+ andtberatioofCD4+ /CDS+ (r≥0. 472, P <0.05). Conclusion The disorder cfcellular immunological function was possible related with the loss of serum melatonin, and the loss of serum melatonin maybe one of the reasons for febrile seizures relapse and brain injured.     

5岁以上儿童5μg重组乙型肝炎疫苗(酵母)加强免疫效果评价

目的比较不同剂次重组乙型肝炎(乙肝)疫苗(酵母)[Hepatitis B vaccine made by recombinantdeoxyribonucleic acid(DNA)techniques in polymorpha Yeast,HepB-Y]加强免疫效果,为加强免疫决策提供依据。方法选择一周岁内完成乙肝疫苗(Hepatitis B vaccine,HepB)基础免疫的5岁以上儿童1728例,采集血清,使用化学发光法检测乙肝病毒表面抗原(Hepatitis B virus surface antigen,HBsAg)、乙肝病毒表面抗体(抗-HBs)、乙肝病毒核心抗体(抗-HBc),对仅抗-HBs阳性者接种5μg重组HepB-Y一剂次、抗-HBs阴性者接种三剂次,接种后1个月采血检测抗-HBs。结果加强免疫前、加强免疫一剂次和三剂次后抗-HBs阳性率分别为40.10%、94.04%、99.54%,三者两两之间抗-HBs阳性率差异均有统计学意义(P<0.05)。抗-HBs阴性者加强免疫一剂次、三剂次后抗-HBs阳转率分别为88.50%、99.42%,二者差异有统计学意义(P<0.05),加强一剂次后,各年龄组儿童抗-HBs阳转率随年龄增加呈下降趋势(P<0.05),加强三剂次后,各年龄组儿童抗-HBs阳转率与年龄未呈现相关性(P>0.05)。抗-HBs阴性者加强免疫一剂次、三剂次后几何平均滴度(geometric means of titer,GMT)分别为450.47IU/L、664.95IU/L,抗-HBs阳性者加强免疫一剂次后GMT为3 663.68IU/L。结论采用5μg重组HepB-Y对5岁以上抗-HBs阳性儿童加强免疫一剂次、对5岁以上抗-HBs阴性儿童加强免疫三剂次,免疫效果良好。     

儿童甲乙型肝炎联合疫苗加强免疫效果评价

目的比较甲、乙型肝炎联合疫苗(hepatitis A and hepatitis B combined vaccine,HepA and HepB)加强免疫效果,为加强免疫决策提供依据。方法选择1周岁内完成乙型肝炎(乙肝)疫苗(hepatitis Bvaccine,HepB)基础免疫的5岁以上儿童1 387例,采集血清,使用化学发光法检测乙肝病毒表面抗原(HBsAg)、乙肝病毒表面抗体(抗-HBs)、乙肝病毒核心抗体(抗-HBc)、甲肝病毒抗体(抗-HAV),对儿童接种甲乙肝联合疫苗一剂次,免后1月采血检测抗-HBs、抗-HAV。结果加强免疫前、加强免疫一剂次甲乙肝联合疫苗后,抗-HBs阳性率分别为49.32%、93.58%,抗-HAV阳性率分别为63.52%、93.08%,加强免疫前后抗-HBs阳性率和抗-HAV阳性率差异均有统计学意义(P均<0.05)。加强免疫一剂次甲乙肝联合疫苗后,抗-HBs阳转率、抗-HAV阳转率分别为87.34%、81.03%,且5～14岁儿童抗-HBs阳转率、抗-HAV阳转率均随年龄增加呈下降趋势(P<0.05)。加强免疫一剂次甲乙肝联合疫苗后,抗-HBs、抗-HAV几何平均滴度(GMT)分别为1326.97U/L、11.11U/L。结论采用甲乙肝联合疫苗对小年龄儿童加强免疫一剂次免疫效果良好,对大年龄儿童建议增加加强免疫剂次。     

倍尔来福TM甲、乙型肝炎联合疫苗安全性和免疫原性研究

目的 观察倍尔来福~(TM)甲、乙型肝炎(甲、乙肝)联合疫苗的安全性和免疫原性。方法以高中一年级(成人组)和小学1～5年级(儿童组)学生为研究对象,按对甲、乙肝病毒均易感、只对甲肝病毒易感和只对乙肝病毒易感分为AB组、A组和B组,按0、1和6个月三剂程序分别接种甲、乙肝联合疫苗、灭活甲肝疫苗和重组乙肝疫苗。疫苗剂量成人组每剂含甲肝病毒抗原500U和(或)HBsAg10μg,儿童组减半。疫苗接种后72h内观察副反应,免疫后2、7个月采集血清标本检测抗-HAV和抗-HBs。结果 儿童AB组和成人AB组局部副反应发生率分别为0.58％(2/344)和2.56％(8/312),全身副反应发生率分别为9.88％(34/344)和5.45％(17/212),与对照组相比差异无显著性。局部反应主要是轻度疼痛,全身反应主要是低热。免疫后7个月,两组抗-HAV阳转率均为100％,与A组相同;抗体滴度(GMT)分别为33 910mIU/ml和23 435 mIU/ml,显著高于A组;两组抗-HBs阳转率分别为97.30％和96.63％;GMT为103 mIU/ml和102 mIU/ml,抗-HBs阳转率及GMT均与B组差异无显著性。结论 倍尔来福~(TM)甲、乙肝联合疫苗与单价甲肝灭活疫苗和单价重组乙肝疫苗具有相同的安全性和免疫原性。     

乙型肝炎基因重组疫苗免疫效果及持久性观察

目的 探讨乙肝基因重组疫苗对新生儿的免疫效果及免疫持久性。方法 随机选择珠海市1999～2003年出生、母亲HBsAg阴性、严格按免疫程序及时全程完成3针基础国产基因重组乙肝疫苗（5ug）的儿童，按免疫后不同的时间段分成6组，采集静脉血分别进行抗-HBs、HBsAg和抗-HBc检测。结果 抗-HBs有效阳性率（≥10mlU／ml）、几何平均滴度（GMT）逐年下降，分别由基础免疫完成后1个月的95，45％和65．36mlU／ml，降至4年后的38．27％和6．56mlU／ml，免疫1年后的下降率最为显著。及时完成3针基础乙肝疫苗免疫后各不同时间段的儿童HBsAg阳性率均不超过1％，抗-HBc阳性率和HBV感染率均小于2％，未见随年限延长而增张的趋势。结论 基因重组乙肝疫苗在新生儿中免疫效果良好，存在较好的免疫持久性和保护效果，在全程免疫后5年内没有必要进行加强。     

Long-term persistence of anti-HBs after vaccination against HBV: an 18 year experience in health care workers

The aim of the present study was to evaluate the long-term persistence of seroprotection after hepatitis B virus (HBV) vaccination. A total of 422 health care workers (HCWs) were evaluated 4.8-18.8 years after primary immunization (mean follow-up 11.8 years); 241 of them had received plasma-derived vaccines and 181 had been given yeast-derived vaccines; 107 subjects received a booster dose of yeast-derived vaccine 6 years after primary immunization with either plasma-derived or yeast-derived vaccines. Seroprotection was assumed when the anti-HBs titers were >10 mIU/ml. The overall response after primary immunization was 98.8%. Among subjects who reached a 10 year follow-up, those treated with plasma-derived vaccine had a seroprotection rate of 87.8 compared to 81.6% of those vaccinated with yeast-derived vaccines (P<0.001). Anti-HBs geometric mean titers (GMTs) after primary immunization were similar in the two groups, but were significantly lower at 10 years follow-up in the group that had received a yeast-derived vaccine (104 mIU/ml versus 244 mIU/ml in those who used a plasma-derived vaccine, P<0.05). Anti-HBs GMTs in the 107 subjects given the booster dose were 242 mIU/ml pre-booster titer, and rose to 35,171 mIU/ml after the booster dose. A mean 10.1 years after the booster dose, GMTs were 952 mIU/ml. Overall, the anti-HBs seroprotection rate was 95.4% (102 subjects). Based on GMT results, no booster dose is necessary in healthy adults for at least 10 years after primary immunization.     

Hepatitis B immunization of newborns according to a two dose protocol

Experimental hepatitis B immunization trial in newborns was carried out in Burundi. Newborns were randomly divided into vaccine and control groups. Vaccinated newborns were given two infections of hepatitis B vaccine: one at birth and another 2 months later. A booster dose was given at 12 months of age. Results obtained show that two months after the second dose of HB vaccine, 96.8% of the vaccinated babies had anti-HBs; at the age of one year this figure had fallen to 83.8%. Six months after the booster dose, 95.6% were anti-HBs positive, with a geometric mean titre of 214 mIU ml⁻¹. The anti-HBs responses in these infants was compared to those observed in previous studies performed in Senegal in infants (same protocol) or in newborns (3 dose protocol). The anti-HBs responses were lower in terms of mean titre values in neonates who received the two dose protocol than in older children and in neonates who received three doses at one month intervals. Vaccine efficacy was monitored during a two year period in neonates both immunized and nonimmunized. Protective efficacy was found to be 100% if considering HBsAg positive events and 75% if considering all HBV events (HBsAg and/or anti-HBc positive).     

儿童乙型肝炎疫苗免疫和加强免疫后保护性抗体观察

目的评价儿童乙型肝炎(乙肝)疫苗(HepB)免疫后保护性抗体应答水平及乙肝病毒表面抗体(抗-HBs)阴性儿童加强免疫后抗体的变化。方法采取多阶段整群系统抽样方法抽取调查单位和儿童,用固相放射免疫方法检测接种儿童血清乙肝病毒表面抗原(HBsAg)、抗-HBs和乙肝病毒核心抗体水平,并对抗-HBs阴性儿童进行加强免疫。结果3~12岁儿童抗-HBs平均阳性率为49.3%,几何平均浓度(GMC)为70.22毫国际单位/毫升(mIU/ml)。重组乙肝疫苗(酵母)免疫后3~6岁儿童抗-HBs阳性率为37.6%,随年龄增长而下降,GMC为55.29mIU/ml,各年龄组差异有非常显著的统计学意义。6~12岁儿童使用血源HepB,抗-HBs阳性率为51.0%,GMC为68.27mIU/ml,各年龄组差异无显著的统计学意义。抗-HBs阴性儿童加强免疫后抗体阳转率为93.9%,GMC为91.83mIU/ml。结论儿童HepB免疫后12年保护性抗体应答良好,HBsAg阳性率未随免疫时间延长而增加,目前尚不需进行加强免疫。抗-HBs阴性儿童加强免疫后有很好的回忆反应。     

北京市儿童乙型肝炎疫苗接种12年后免疫效果观察

目的评价北京市儿童乙型肝炎(乙肝)疫苗接种12年后的免疫效果。方法2003年1至3月采取多阶段整群系统抽样方法在1991至2000年出生后接种乙肝疫苗的儿童中抽取2491人,用固相放射免疫法检测血清HBsAg、抗-HBs和抗-HBc水平,并对免疫后HBsAg阳性的原因进行分析。结果2491名3—12岁儿童中HBsAg阳性率为0．52％,疫苗免疫保护率为88．45％(95％CI为65．67％-97．89％),抗-HBc阳性率为2．21％,各年龄组比较差异无统计学意义。接种重组(酵母)疫苗的3—6岁儿童,其抗-HBs平均阳性率为38．79％,但随年龄增大抗体阳性率明显下降;几何平均滴度为52．83mlU／ml,各年龄组比较差异无统计学意义。接种乙肝血源性疫苗的6—12岁儿童,其抗-HBs平均阳性率为50．79％,几何平均滴度为61．51mlU／ml,各年龄组抗体阳性率和几何平均滴度比较差异均无统计学意义。在13例HBsAg阳性儿童中,约50％儿童的母亲为HBsAg阳性。结论北京市儿童乙肝疫苗接种计划实施12年后,免疫人群保护效果理想,HBsAg阳性率未随免疫时间延长而明显增加。目前尚不需进行加强免疫,但重组(酵母)疫苗接种后抗-HBs阳性率随年龄增长而显著下降,应加强血清学监测。儿童接种后成为HBsAg携带者的主要原因为母婴垂直传播。     

国产甲型肝炎灭活疫苗在低龄儿童中应用的安全性和免疫原性研究

目的 探讨国产甲型肝炎灭活疫苗在低龄儿童（1－4岁）中应用的安全性和免疫原性。方法 选1－4岁易感健康儿童63名，随机分为两组，按0，3和0，6程序接种国产甲肝灭活疫苗500U／剂，观察免疫后的局部和全身反应，并检测初免后及全程免疫后的抗－HAV阳转率和抗体GMT。结果 初免和加强免疫后有轻微的过性局部和全身反应，未见肝功异常。初免后1、3、6个月抗体阳转率分别为85.7%、88.5%和83.8%；抗体GMT玢别为182mU/ml、225mU/ml和252mU/ml；0，3和0，6程序全程免疫后1个月抗体阳转率均为100％；抗体GMT分别为2718mU/ml和4683mU/ml。结论 国产甲肝灭活疫苗在低龄儿童中应用具有良好的安全性和免疫原性；接种两剂可获高滴度甲肝抗体；0，6程序优于0，3程序。