国产重组酵母乙肝疫苗对成人的免疫效果

目的:了解国产重组酵母乙肝疫苗(YDV)5μg和10μg对成人的安全性和免疫学效果.方法:199例研究对象随机分为2组,分别接受YDV 5μg和10μg,每人每月肌内注射1次,共3次(全程免疫)后1个月,进行免疫效果观察.检测血清乙肝表面抗体阳转率和乙肝表面抗体平均几何滴度(GMT),并观察2组的不良反应.结果:研究对象中未发现中、重度的局部和全身不良反应.接种5μg和10μg疫苗组的乙肝表面抗体阳转率分别为89.25%及98.11%;乙肝表面抗体GMT分别为18.88及54.47mIU·mL-1,2组的GMT差异有显著性(P＜0.05).结论:YDV成人免疫是安全的,10μg YDV抗乙肝表面抗体的GMT明显高于5μg YDV.     

成人接种重组(酿酒酵母)乙肝疫苗和重组(汉逊酵母)乙肝疫苗后效果观察

目的观察重组(酿酒酵母)乙肝疫苗和重组(汉逊酵母)乙肝疫苗在成人中的免疫效果。方法对HBsAg、抗HBs、抗HBc三项指标全部为阴性、且未接种过乙肝疫苗的162名16岁以上人群,按照0、1、6的免疫程序接种10μg重组(酿酒酵母)乙肝疫苗和重组(汉逊酵母)乙肝疫苗,于全程免疫1个月后采血,测定血清中抗HBs水平。结果接种重组(酿酒酵母)乙肝疫苗的99人,抗HBs阳转率为94.95%,几何平均浓度为331.08mIU/mL;接种重组(汉逊酵母)乙肝疫苗的63人,抗HBs阳转率为98.41%,几何平均浓度为270.79mIU/mL。两组间抗HBs阳转率和几何平均浓度差异均无统计学意义(P>0.05)。接种两种疫苗均未观察到明显的不良反应。结论重组(酿酒酵母)乙肝疫苗和重组(汉逊酵母)乙肝疫苗均具有良好的安全性和免疫原性。     

两种剂量重组酵母乙肝疫苗免疫效果比较

目的 为了解不同剂量重组酵母乙肝疫苗封成人免疫效果。方法采用0、1、6月免疫程序，对98位18-40岁健康成人接种5ug和10ug两种剂型重组酵母乙肝疫苗。结果 接种10ug组个别人有轻度反应，5ug组无任何全身和局部反应。两组观察对象于初免后36个月，检测抗-HBS阳转率分别为84．00％、61．22％，抗体GMT滴度为197．53和110．66。结论 接种重组酵母乙肝疫苗后3年采用检测高剂量抗体阳转率和抗体GMT滴度显着高于低剂量组。说明成人接种10ug重组酵母乙肝疫苗免疫效果优于5ug。     

新生儿接种重组乙肝疫苗后安全性及免疫效果观察

目的评价新生儿全程接种重组乙肝疫苗后其安全性及免疫效果。方法2006～2008年HBsAg阴性母亲所生新生儿4240例按0、1、6个月程序,剂量为5μg/支,全程免疫后1个月进行安全性及免疫效果观察。结果乙肝疫苗全程接种后抗-HBs阳转率为95.17%,仅1例接种部位出现直径﹤2cm红肿硬结,无严重接种反应。结论新生儿接种重组乙肝疫苗（酵母）安全性强,接种后有良好免疫效果。     

大学生接种不同剂量乙肝疫苗后免疫效果观察

目的观察评价重组酵母乙肝疫苗(YDV)接种后的安全性和免疫学效果。方法对某大学两组采用不同免疫剂量的新生(Ⅰ组:0.5μg×3和Ⅱ组:10μg×3),均按0、1、6个月程序作乙肝免疫注射,于第一针免疫注射后第12个月的HBsAb阳性率情况作统计分析。结果两组HBsAb阳转率分别是:Ⅰ组76.33%(329/431),Ⅱ组91.07%(367/403)。χ2=32.74,P<0.01,两组对比有显著性差异。两组在免疫注射后,局部和全身均未见不良反应。结论YDV对成人具有良好的免疫原性和安全性。采用较大剂量YDV对成人的免疫效果优于低剂量组。     

重组(酵母)乙肝疫苗免疫效果观察

乙肝病毒(HBV)感染是世界范围内最重要的慢性病之一,其危害在于引起慢性肝病,肝硬化甚至诱发肝细胞癌(HCC).应用乙肝疫苗接种是预防和阻断乙肝病毒传播、流行的最根本措施.我国于1985年引进生产重组(酵母)乙肝疫苗(YDV)并广为应用,其免疫原性、安全性及保护效果以及是否需要加强免疫一直被人们所关注[1～3].我院开展了新生儿YDV接种工作并对抗-HBs进行了7年的观察,现将结果报告如下.     

国产和进口重组乙肝疫苗在15岁以下儿童中的免疫效果研究

目的：探讨国产和进口重组乙肝疫苗在15岁以下儿童中的免疫效果。方法国产组采用深圳康泰生物制品有限公司生产的重组酵母乙肝疫苗进行免疫接种;进口组采用英国葛兰素史克公司提供的重组酵母乙肝疫苗进行免疫接种,于接种完成后对两组儿童进行血清抗-HBs检测,记录两组儿童抗-HBs检测结果及接种后不良反应发生情况,给予统计学分析后得出结论。结果国产组抗-HBs阳性率96.00%、进口组抗-HBs阳性率97.00%（P〉0.05）。国产组不良反应发生率3.00%、进口组不良反应发生率2.00%（P〉0.05）。结论临床使用价格更为经济的国产重组酵母乙肝疫苗进行免疫接种工作可显著降低接种人群经济压力,提高接种疫苗依从性,利于更为有效的控制乙肝病毒感染率。     

大学生接种基因重组乙肝疫苗免疫效果观察

目的：了解基因重组乙肝疫苗在19-23岁的人群中免疫效果。方法：采用酶联免疫法检测接种学生血清中乙肝病毒抗原、抗体。对HBsAg HBsAb阴性者，应用0、1、6月3针方案，每次肌肉注射基因重组乙肝疫苗5μg／m1。结果：全程免疫结束后，阳转率为98％。男性阳转率与女性阳转率的比较差异无显著性。结论：入学新生注射基因重组乙肝疫苗有效率为98％，而且抗HBs滴度随着疫苗注射次数、刺激时间而增高。是防止乙肝在学校发生与流行的有效措施。     

重组(酵母)乙型肝炎疫苗免疫效果观察

目的 观察重组(酵母)乙型肝炎(乙肝)疫苗在新生儿接种后的免疫效果,探究乙肝疫苗再免的需求.方法 对上海市黄浦区1997年出生并接种合格乙肝疫苗的儿童,在免疫后1、3、5、7年采血随访观察,检测HBsAg、抗-HBs和抗-HBc,并开展急性肝炎流行病学监测.  结果 7年问,免疫人群HBsAg阳性率在1.5%上下波动,平均为1.47%(95%可信区间为0.61%～2.33%),与免疫前同一地区乙肝流行病学调查本底资料比较,乙肝疫苗保护效果为84.03%(95%可信区间78.92%～89.60%).1997年接受乙肝疫苗免疫人群中,无急性乙肝发病.  结论 新生儿重组乙肝疫苗免疫后效果良好,目前无需考虑再免.     

Immunogenicity of a recombinant yeast-derived hepatitis B vaccine (Engerix B) in children

Eighty-one children seronegative for markers of hepatitis B virus infection aged 0-10 years received 10 micrograms of a yeast-based hepatitis B vaccine (Engerix B) at 0, 1, and 6 months. Eighty subjects responded with a geometric mean titre of 7640 IU/L one month after the third dose. All seroconverters produced high level of antibodies regardless of age, race, or sex. It is concluded that Engerix B used in the dose and schedule described is highly immunogenic.     

Immunity to hepatitis B in two birth cohorts given plasma-derived or yeast-derived vaccine.

AIM: To determine the antibody response to either yeast-derived or low-dose, plasma-derived hepatitis B vaccine, in two cohorts of infants monitored by an immunisation coordinator and immunised by general practitioners. METHODS: Infants born to two cohorts of non-carrier mothers in Northland were followed up, the first receiving a low-dose, plasma-derived vaccine, the second a yeast-derived vaccine. An immunisation coordinator enrolled the mothers into the programme during pregnancy, promoted full immunisation against hepatitis B and later obtained blood samples from their babies. In each cohort, four subsamples of babies, randomly assigned, were bled for estimation of antibody levels to hepatitis B at ages 18, 30, 42 and 54 months (1 1/2, 2 1/2, 3 1/2, 4 1/2 years). No infant was bled more than once. RESULTS: In both cohorts, antibody levels declined significantly with age. By age 4 1/2 years, 5.1% of children (95% confidence interval (CI): 3.5-7.1) immunised with yeast-derived vaccine were estimated to have antibody levels to hepatitis B below the acceptable level for protection of 10 IU/L. The proportion for those immunised with plasma-derived vaccine was 14.3% (95% CI: 7.4-24.1). CONCLUSIONS: Children receiving yeast-derived vaccine do not require a second booster dose at school entry, although this might be considered at age 11. There are grounds to suggest that those who received low-dose, plasma-derived vaccine (prior to 1990) should be offered a booster before age 11.     

Antibody responses to recombinant, yeast-derived hepatitis B vaccine in teenage New Zealand children

Three groups of healthy teenage New Zealand children were given 2.5 micrograms, 5 micrograms and 10 micrograms, which is the currently recommended dose, of Merck Sharp and Dohme recombinant yeast-derived hepatitis B vaccine at time 0, 1 and 6 months and tested for antibody responses to vaccine and for other hepatitis B virus markers. Seroconversion rates exceeded 98% in all three groups. Geometric mean titres (GMT) of the anti-HBs increased with higher doses. There was no significant differences in GMT between the sexes. Under the conditions of this study, 2.5 micrograms doses of this vaccine induced an excellent antibody response in children 12-14 years of age.     

成人大规模免疫乙肝疫苗的无应答状况及影响因素分析

目的 探讨自然人群中成人接种重组乙肝疫苗后无应答者分布状况和影响因素.方法 对某地21699名16岁以上成人按0、1、6方案接种10μg乙肝疫苗后进行免疫学检测,描述无应答的分布并分析影响因素.结果 成人全程接种重组乙肝疫苗第三针后1个月,总抗体保护性阳转率97.23%,无应答率2.77%,16～49岁人群无应答率低于50岁以上人群.影响因素分析表明年龄越大抗体保护性阳转率越低(P<0.01),无应答率越高,男性无应答率高于女性(P<0.05).结论 成人全程接种10μg重组乙肝疫苗免疫效果较好,无应答率较低;50岁以上男性无应答率较高.     

Novel nanoparticles for the delivery of recombinant hepatitis B vaccine

We describe the use of methoxypolyethylene glycol-poly(lactide-co-glycolide) nanoparticles as a delivery system for recombinant hepatitis B surface antigen (HBsAg). Evaluation of the stability and release kinetics of nanoencapsulated HBsAg in vitro in serum revealed an initial burst effect and a subsequent slower release of the antigen. Importantly the antigenicity was not destroyed by the encapsulation process, because upon release it was able to react with an anti-HBs antibody. Bone marrow-derived dendritic cells showed efficient uptake of the nanoparticle vaccine as visualized by confocal imaging. To determine whether nano-encapsulated HBsAg was capable of eliciting an immune response in the absence of an adjuvant, mice were immunized with the nanoparticle vaccine or with nonencapsulated recombinant HBsAg. In mice immunized with the nanoparticle vaccine, anti-HBs antibodies were detected at significantly earlier time points than in mice immunized with the nonencapsulated recombinant HBsAg.     

The safety and immunogenicity of a recombinant hepatitis B vaccine in neonates

A study to evaluate the safety and immunogenicity of a yeast derived recombinant DNA hepatitis B vaccine (Engerix-B) was conducted in healthy newborn infants born to low risk European mothers negative for hepatitis B surface antigen (HBsAg). The vaccination schedule using 20 micrograms doses was administered intramuscularly at 0, 1 and 6 months. The seroconversion rate was 99% (90 of 91 infants). The geometric mean titer of antibody to hepatitis B was 1259 mIU/mL one month after the third dose of vaccine. Possible side effects reported by the mothers were minor and uncommon. This vaccine is highly immunogenic and safe for use in infants.