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1.
重组酵母乙型肝炎疫苗对乙肝母婴传播阻断效果观察   总被引:1,自引:0,他引:1  
以北京生物制品研究所引进美国Merck公司基因工程技术生产的重组酵母乙型肝炎(乙肝)疫苗,阻断乙肝病毒的母婴传播,结果HBsAg、HBsAg双阳性孕妇分娩的新生儿,全程免疫后7个月和12个月的保护率分别为96.7%和96.0%;抗-HBs阳转率分别为94.7%、93.5%;GMT分别为66.6mIU/ml、76.6mIU/ml。优于血源性乙肝疫苗。  相似文献   

2.
为获得更为快速的免疫应答,用30μg/ml乙肝血源疫苗以0、2、6周免疫程序对68名HBsAg阳性母亲婴儿作了阻断HBV母婴传播免疫效果的观察,并与常用的0、1、6接种方案的结果进行了比较。结果表明HBIG合用乙肝疫苗或单用疫苗组产生抗-HBs(〉10mIU/ml)血清转换率于T6m、T12m时分别为91.89%和83.87%,81.08%和83.87%。短程和常规免疫方案婴儿所产生的保护性抗-H  相似文献   

3.
重组酵母乙型肝炎疫苗免疫原性免疫持久性及保护效果   总被引:29,自引:7,他引:22  
对重组酵母乙型肝炎(乙肝)疫苗(YDV,5μg/剂)的免疫效果、免疫持久性及保护效果进行了观察。应用0、1、2免疫程序免疫了613名6~9岁的小学生,分别接种了刀批YDV,全程免疫后1个月,其血清抗-HBs阳转率为96%~100%,总阳转率为99%.YDV的免疫持久性观察结果表明,每剂5μgYDV和10μg血源乙肝疫苗(PDV)免疫后2年,其抗-HBs≥10mIU/ml者均在91%以上,两者无显著差异。乙肝母婴传播阻断的保护效果,用5μgYDV免疫65名HBsAg及HBeAg双阳性母亲所生婴儿,应用0、1、6免疫程序,全程免疫后7个月(12月龄)在石家庄和横县两地区的保护率分别为%%及92%。由此表明:YDV免疫原性良好,可完全取代血源乙肝疫苗。  相似文献   

4.
乙肝基因工程疫苗阻断HBV母婴传播的效果观察   总被引:2,自引:0,他引:2       下载免费PDF全文
对国产痘苗病毒乙肝基因工程疫苗(北京生物制品研究所研制)和地鼠卵巢细胞乙肝基因工程疫苗(长春生物制品研究所研制)进行阻断乙肝母婴传播的效果观察,剂量为20μg/支×3,接种HBsAg和HBeAg均阳性母亲的新生儿各40例,观察时间≥9个月者分别为33例和29例。结果:全部新生儿均无局部或全身不良反应,T1时抗-HBs阳转率分别为3.0%和13.8%;T9时达高峰,分别为78.8%和79.3%;疫苗保护率分别为79.2%和80.2%;抗-HBs滴度(S/N均值)T9时为高峰,分别为113.04和99.11。各组中均有1例抗-HBs和HBsAg同时持续阳性;并分别有1例和2例抗-HBs均持续阴性。结果表明国产乙肝基因工程疫苗均有良好的安全性和免疫原性,其阻断乙肝母婴传播的效果较同剂量血源疫苗好,与30μg血源疫苗的阻断效果相近。  相似文献   

5.
本文应用产前孕妇筛检法阻断乙型肝炎母婴传播进行调查研究。结果表明:①孕妇筛检可及时找准防治重点,采取一般孕妇和HBsAg阳性孕妇分开分娩,并实行特别护理等综合措施,减少了感染及交叉感染机会。②了解到我市孕妇HBsAg阳性感染率为5.1%,和本地区人群感染率基本相符(4-6%)。③HBsAg阳性孕妇中HBeAg同时阳性者(59/141)占41.8%。观察50名母亲所生婴儿12月龄时8名阳性占16%。其中双阳性母亲所生婴儿感染率为35%,单阳性3.3%,双阳性母亲所生婴儿明显高于单阳性。④母亲抗体滴度≤1:8观察30例,12月龄、48月龄时无1例感染;≥1:256观察20例,12月后阳转3例占15%,表明HBV传染主要取决于母体的感染程度。⑤对HBsAg和HBsAg、HBeAg双阳性母亲所生婴儿全程免疫12月后阳转率分别为87.5%和76.6%;48月龄后阳转率为27.5%和26.6%,表明单阳组阻断效果优于双阳组。揭示对这部分高危状态的人群,应在一年后加强注射。⑥孕妇产前筛检可揭示我们实施防治对策,是一项既经济又行之有效的防治措旋。  相似文献   

6.
两种阻断围产期乙肝母婴传播方法的效果观察   总被引:1,自引:0,他引:1  
我国曾有报道[1],乙肝表面抗原(HBsAg)阳性母亲的婴儿出生6个月内有24.3%~45%HBsAg阳性。因而加强对新生儿乙肝疫苗的接种,阻断围产期HBV的传播是预防乙肝的一种有效手段。1996年1月至1997年1月,我们筛选HBsAg阳性产妇的新...  相似文献   

7.
重组酵母乙肝疫苗阻断母婴传播效果观察   总被引:3,自引:1,他引:2  
应用重组酵母乙肝疫苗对HBsAg/HBeAg双阳母亲的新生儿免疫,阻断HBV的母婴传播,结果婴儿3、9、12月龄的保护率分别为85.5%、90.0%、91.8%;抗-HBs阳转率分别为83.0%、92.0%、93.8%;GMT分别为37.6mIU/ml、71.8mIU/ml、67.7mIU/ml。较血源性乙肝疫苗为优。  相似文献   

8.
国产乙肝基因工程疫苗免疫持久性研究   总被引:2,自引:1,他引:1  
目的 国产乙肝基因疫苗应用时间不长,其免疫持久性尚不清楚。为评价国产乙肝CHO疫苗的免疫效果和免疫持久性而进行本研究。方法 应用两批国产乙肝CHO疫苗(长春生物制品研究所生产),10μg/剂。按0、1、6程序免疫150名HBVm阴性儿童,免疫后随访观察56月。结果 全部接种儿童均无局部和全身异常反应。T7时抗--HBs阳转率均为100%,T56时阳转率分别为88.57%和78.57%。结论 国产乙  相似文献   

9.
为获得更为快速的免疫应答,用30μg/ml乙肝血源疫苗以0、2、6周免疫程序对68名HBsAg阳性母亲婴儿作了阻断HBV母在传播免疫效果的观察,并与常用的0、1、6接种方案的结果进行了比较。结果表明HBIG合用乙肝疫苗或单用疫苗组产生抗-HBs(>10mIU/ml).血清转换率于T(6m)、T(12m)时分别为91.89%和83.87%,81.08%和83.87%。短程和常规免疫方案婴儿所产生的保护性抗-HBs水平动态比较,表明以0、2、6周免疫后在T(6w)、T(6m)时的抗-HBs有效率分别为19.35%和83.87%,明显高于0、1、6月免疫者同期抗体水平(P<0.01).至T(12m)时两组的阳转率无显著性差异。说明0、2、6周免疫方案能早期诱导出保护性抗-HBs免疫应答.  相似文献   

10.
乙肝基因工程疫苗阻断HBV母婴传播的效果观察   总被引:6,自引:0,他引:6       下载免费PDF全文
对国产痘苗病毒乙肝基因工程疫苗(北京市生物制品研究所研制)和地鼠卵巢细胞乙肝基因工程疫苗(长春生物制品研究所研制)进行阻断乙肝母婴传播的效果观察,剂量为20μg/支×3,接种HBsAg和HBeAg均阳性母亲的新生儿各40例,观察时间≥9个月者分别炒33例和29例。结果:全部新生儿均无局部或全身不良反应,T1时抗-HBs阳转率分别为3.0%和13.8%;T9时为高峰,分别为113.04%和99.11  相似文献   

11.
161例婴儿接种乙型肝炎(简称乙肝)疫苗后免疫应答良好。接种20μg疫苗的婴儿抗-HBs阳转率为100%,几何平均滴度为1:448.9;接种10μg疫苗的婴儿抗-HBs阳转率为97.3%,滴度为1:217.8。母亲的HBV感染状态与婴儿对乙型肝炎疫苗的免疫应答有密切关系。母亲单独抗-HBs阳性的婴儿,接种乙型肝炎疫苗后的抗-HBs应答最佳(阳转率为100.0%,几何平均滴度1:670.4),依次为母亲HBV感染标记全阴性的婴儿(100.0%,1:376.4)。母亲抗-HBs和抗-HBc共阳性的婴儿(100.0%,1:218.2);而母亲为HBsAg阳性或单独抗-HBc阳性的婴儿的抗-HBs应答较差(75.0%,1:40.3;或100.0%,1:28.5)。本次研究提示机体的遗传特征以及母体HBV传染性强弱对婴儿接种乙型肝炎疫苗后的免疫应答起决定作用。  相似文献   

12.
HBsAg阳性母亲的新生儿乙型肝炎疫苗免疫后追踪观察   总被引:10,自引:0,他引:10  
目的探讨不同方案乙型肝炎疫苗免疫,对母亲HBsAg阳性新生儿的免疫持久性。方法在203名HBsAg阳性母亲的新生儿出生时,按不同方案和剂量注射乙型肝炎疫苗,免疫后6年内连续进行抗-HBs和HBsAg携带情况的追踪观察。结果6年内抗-HBs阳性率一直高于90%;新生儿免疫后抗-HBs在7月龄到1岁形成高峰,在1~2岁期间下降了48.82%,2~6岁期间保持相对稳定;8例抗-HBs阴转后3~5年仍未被感染;14例抗-HBs阴转1~2年后又产生抗-HBs;无一例成为HBsAg携带者。结论乙型肝炎疫苗免疫后6~10年可不进行加强免疫。  相似文献   

13.
目的探讨免疫阻断治疗后新生儿乙肝病毒标志物的动态变化。方法193例乙肝病毒(HBV)携带孕妇分娩的193例新生儿于出生后12h内肌注乙肝免疫球蛋白(HBIG)200U,同时在另一部位肌注重组酵母乙肝疫苗(HBVac)10μg。新生儿出生后即刻、6、12、18个月时采静脉血检测HBV标志物(HBVM)及HBVDNA。结果出生时新生儿乙肝表面抗体(HBsAg)阳性率16.6%,宫内感染率为3.6%。孕妇血清HBsAg、HBeAg、抗HBc均阳性,HBVDNA〉1500拷贝/ml分娩的非宫内感染婴儿出生时HBsAg阳性占13.3%,6月龄时均转阴;出生时抗HBs均阴性,12月龄时均转为阳性;出生时HBeAg阳性占95.2%,12月龄时均转阴;抗HBe始终为阴性;出生时抗HBc均为阳性,12、18月龄时阳性占31.3%和27.1%。孕妇血清HBsAg、抗HBe、抗HBc均阳性,HBVDNA≥500拷贝/m1分娩的非宫内感染婴儿出生时HBsAg阳性占5.0%,6月龄时转阴;出生时抗HBs均为阴性,12月龄时均转阳性;HBeAg始终为阴性;出生时抗HBe均阳性,12月龄时均转阴;出生时抗HBc均阳性,12、18月龄时阳性占65.0%和50.O%。出生时非宫内感染婴儿与母亲HBsAg阳性率(12.4%与100.0%)差异有统计学意义;抗HBs均阴性;抗HBc均阳性;HBeAg阳性、抗HBe阳性差异元统计学意义。结论HBV感染孕妇所生婴儿,只要及时给予HBIG与HBVac免疫阻断,可降低HBV感染率。HBeAg、抗HBe或抗HBc阳性随着日龄增长,可逐步转阴,且HBeAg、抗HBe转阴比抗HBe快。  相似文献   

14.
《Vaccine》2015,33(33):4093-4099
ObjectiveTo compare the safety and immunogenicity of two dosages of recombinant hepatitis B (HB) vaccine administered to infants born to HB-uninfected and HB-infected mothers.MethodsA phase III, controlled, single-blinded clinical trial was conducted with 506 healthy newborns. The newborns were assigned to three groups based on maternal levels of HB surface antigen (HBsAg) and HB e antigen (HBeAg): Group A, HBsAg negative; Group B, HBsAg positive and HBeAg negative; and Group C, HBsAg positive and HBeAg positive. Three doses of 10 or 5 μg recombinant HB vaccine were randomly administered by 1:1 within 24 h after birth, at 1 month and at 6 months. Safety data and pre- and postvaccination blood samples were collected.ResultsA total of 326, 93, and 87 subjects were included in Groups A, B, and C, respectively. Both dosages of HB vaccine were well tolerated by all subjects. The most common injection-site adverse reactions (ARs) and systemic ARs were pain and fever. After 1 month of the third dose, the Group A infants who received the 10 μg HB vaccine achieved a higher geometric mean concentration (GMC) of HB surface antibody (anti-HBs) than those who received the 5 μg dosage. Maternal anti-HBs serostatus did not influence HB vaccine immunogenicity at either dosage. In contrast, there was no significant difference in the anti-HBs seroconversion rate, GMCs, or estimated vaccine efficacy (EVE) against perinatal transmission between Groups B and C, regardless of dosage. However, the seroconversion rate and EVE of the 5 μg HB vaccine was lower in Group C than in Group B.ConclusionsBoth dosages of the HB vaccine were well tolerated and elicited a good immune response in infants of Group A, regardless of the maternal anti-HBs serostatus. EVE did not significantly differ between Groups B and C.Clinicaltrails.gov identifier: NCT02152709  相似文献   

15.
目的:探讨乙肝免疫球蛋白(HBIG)联合乙肝疫苗阻断乙肝病毒(HBV)母婴传播失败原因。方法:选择HBsAg阳性、HBeAg阳性、HBV-DNA阳性孕妇218例,检测孕妇分娩前HBVDNA,新生儿(出生24h内且未进行阻断前)、7月龄及1岁时婴儿的HBsAg、抗HBs;所有新生儿出生后24h内在三角肌注射HBIG200IU,同时在大腿前部外侧肌内注射基因工程乙肝疫苗10μg,2周再注射同等剂量的HBIG,1、6月时分别注射同等剂量的乙肝疫苗。结果:孕妇分娩前血清HBVDNA含量>1×106copies/ml组7月龄、1岁时HBsAg阳性率分别为18.12%、19.38%,HBVDNA含量<1×106copies/mi组为7.50%、7.25%(P<0.05)。注射HBIG及乙肝疫苗后,宫内感染组7月龄、1岁时HBsAg阳性率分别为75.00%、74.19%,非宫内感染组为3.76%、4.19%(P<0.01)。结论:宫内感染及孕妇分娩前血清HBVDNA含量高是HBV母婴阻断失败的主要原因。采取综合措施可提高母婴阻断效果。  相似文献   

16.
目的探讨乙型肝炎(乙肝)表面抗原(HBsAg)和e抗原(HBeAg)阳性产妇所生新生儿在出生后乙肝疫苗(HepB)和乙肝免疫球蛋白(HBIG)联合免疫以及完成HepB全程免疫后乙肝病毒(HBV)突破性感染的影响因素。方法2016年6月-2017年5月在南昌市2个县(区)选择HBsAg和HBeAg阳性产妇所生新生儿,在联合免疫和HepB全程免疫完成后1-2个月检测血清HBsAg和乙肝表面抗体(HBsAb),分析儿童母婴传播阻断失败率(HBsAg阳性率)。结果本研究共纳入278名婴儿,母婴传播阻断失败率为2.52%(7/278),HBsAb阳性率为96.8%(269/278)。产妇HBsAg阳性时间在2年以上是阻断失败的危险因素,而分娩方式、喂养方式、母亲和婴儿HBIG的使用情况和婴儿性别等与HBV阻断失败率无相关性。结论HepB和HBIG联合免疫对HBsAg和HBeAg阳性产妇所生新生儿具有较好的乙肝母婴传播阻断效果,建议加强育龄妇女HBsAg和HBeAg筛查。  相似文献   

17.
联合应用免疫球蛋白与疫苗阻断乙肝母婴传播效果研究   总被引:2,自引:0,他引:2  
目的评估联合应用免疫球蛋白与乙肝疫苗对阻断乙肝母婴传播的效果,探索最佳阻断方案。方法将220例乙肝病毒表面抗原(HBsAg)、e抗原(HBeAg)双阳性的母亲及其所生新生儿分成3组,第一组母亲在分娩前三个月每月注射一次乙肝免疫球蛋白(HBIG)200IU/ml,出生婴儿按0、2周注射HBIG200IU/ml;第二组婴儿出生后按0、2周注射HBIG200IU/ml;第三组不使用HBIG。所有婴儿按国家免疫程序(0、1、6月)注射乙肝疫苗。对220名儿童进行3年血清学追踪观察(1、2、3岁)。结论联合应用免疫球蛋白与乙肝疫苗对阻断乙肝母婴传播的效果最佳。  相似文献   

18.
《Vaccine》2015,33(36):4618-4622
Hepatitis B virus infection (HBV) is a significant public health problem in sub-Saharan Africa. Universal infant vaccination with the hepatitis B (HB) vaccine has been implemented within the South African Expanded Programme of Immunization since April 1995 with concomitant reduction in HBV infection in children. However, the first vaccine dose is only administered at six weeks of age. This delay may lead to a failure to reduce the risk of perinatal HBV transmission to infants born to HIV/HBV co-infected women, in whom HBV infection is often upregulated. The aim of this study was to determine the prevalence of HBV infection in babies born to HIV-infected mothers in the Western Cape, South Africa. HBV serological markers were tested in all infant serum samples and following HB viral load testing, sequencing and genotyping were also performed. Three of 1000 samples screened tested positive for HBsAg and HBV DNA. An additional infant tested positive for HBV DNA alone. All babies had received the HB vaccine at 6, 10 and 14 weeks. The prevalence of HBV infection was therefore 4/1000 (0.4%; 95% CI, 0.01–0.79%). Three of four infants and all four mothers were followed-up. Two infants were persistently positive for HBsAg with viral loads above 108 International Units per millilitre. All four maternal samples were positive for HBsAg and HBeAg and one was also positive for anti-HBe. Sequencing analysis of two mother–child HBV pairs showed 100% sequence identity. This study demonstrates HBV infection in HIV-exposed infants despite HB vaccination from 6 weeks of age. A more strategic approach is needed to prevent mother to child transmission of HBV, including screening of pregnant women, HBV-targeted antiviral therapy and HB birth dose vaccine.  相似文献   

19.
国产重组酵母乙型肝炎疫苗阻断乙型肝炎母婴传播的研究   总被引:3,自引:0,他引:3  
目的 探讨乙型肝炎基因工程疫苗阻断HBV母婴传播的免疫保护效果和免疫策略。方法 对HBsAg和HBeAg同时阳性母亲的169例新生儿接种国产重组酵母乙型肝炎疫苗,于免后3、9、12、24、36、48月采血进行血清免疫学追踪观察。结果 22例婴儿1岁前HBsAg阳性,19例(11.24%)成为慢性携带者,免后一年阻断保护率为85.94%。抗-HBs阳性率和抗-HBs滴度均于9-12月龄时达一高峰,24和36月龄时有所下降,免后1-4年抗-HBs阳性率分别为96.43%、91.07%、85.19%和70.00%。结论 国产酵母重组乙型肝炎疫苗对HBV母婴传播具有良好免疫阻断效果。母亲HBsAg和HBeAg双阳性的幼儿在3-4岁时需加强免疫。  相似文献   

20.
We conducted a randomized, double-blind clinical trial of an experimental mammalian cell-derived DNA hepatitis B vaccine (Betagen, Connaught Laboratories Ltd, Toronto, Canada) to determine its efficacy in infants born to mothers who were carriers of hepatitis B surface antigen (HBsAg). Four groups of 55 infants received injections as follows: (1) a licensed plasma-derived vaccine (Lanzhou, Lanzhou Institute for Biological Products, Lanzhou, People's Republic of China), 20 micrograms; (2) Betagen, 20 micrograms; (3) Betagen, 20 micrograms+hepatitis B immune globulin (HBIG); and (4) Betagen, 10 micrograms+HBIG. Vaccine injections were given at birth and at 1 and 6 months and HBIG was given at birth. The vaccines were compared to a historical placebo control group. The efficacy of Betagen alone was 82.6% compared to 51.0% for the Lanzhou. Efficacy of Betagen increased with the concomitant use of HBIG. No infants who were HBsAg negative at birth and/or were born to hepatitis B e antigen (HBeAg) negative mothers became carriers. The rate of HBsAg in infants receiving Betagen alone, and born to mothers who were HBeAg positive, decreased from 60% at birth to 20% by the ninth month, compared to 62.5% and 50% (respectively) for Lanzhou. The percentage of infants with protective levels of antiHBs was significantly higher for Betagen alone than for Lanzhou, but the geometric mean titre of antiHBs for responders was not significantly different. We have shown that Betagen alone is highly efficacious in preventing the development of hepatitis B in infants born to mothers who are carriers of HBsAg and is also highly effective in reducing the carriage of HBsAg in infants who are HBsAg positive at birth and/or born to HBeAg positive mothers.  相似文献   

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