在健康的婴儿和效率的免疫原性，以防止母亲到10微克重组酵

StephenW

Vaccine. 2016 Apr 23. pii: S0264-410X(16)30196-7. doi: 10.1016/j.vaccine.2016.04.042. [Epub ahead of print]
The immunogenicity in healthy infants and efficiency to prevent mother to child transmission of Hepatitis B virus of a 10μg recombinant yeast-derived Hepatitis B vaccine (Hep-KSC).Zhu FC1, Sun KX2, Pan HX1, Yang ZH3, Lu Y2, Liang ZL4, Liang XF5, Wang FZ5, Zeng Y6, Li J7.
Author information

• 1Department of Infectious Disease, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.
• 2Department of Microbiology and Infectious Diseases Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China.
• 3Shenzhen Kangtai Biological Products Co., Ltd, Shenzhen 518057, China.
• 4National Institutes for Food and Drug Control, Beijing 100050, China.
• 5Chinese Center for Disease Control and Prevention, Beijing 102206, China.
• 6Shenzhen Kangtai Biological Products Co., Ltd, Shenzhen 518057, China. Electronic address: [email protected].
• 7Department of Microbiology and Infectious Diseases Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. Electronic address: [email protected].
  

AbstractBACKGROUND AND AIMS: To evaluate immunogenicity and efficacy of a 10μg recombinant Saccharomyces cerevisiae-derived hepatitis B vaccine (Kangtai Biological Products Co. Ltd, Shenzhen, China) (Hep-KSC) in newborns.
METHODS: Overall 1197 infants born to mothers negative for HBV markers (NM group) and 534 born to HBsAg-positive mothers (PM Group) were enrolled. Infants in NM group were given 10μg Hep-KSC, 10μg Engerix-B or 5μg Hep-KSC and those in PM group received 10μg Hep-KSC or 10μg Engerix-B at 0, 1 and 6 months, with an additional 200IU HBIG at birth for the latter.
RESULTS: For NM Group, 10μg Hep-KSC paralleled 10μg Engerix-B but outperformed 5μg Hep-KSC regarding seroprotective rate (95.06% vs 94.83% vs 89.67%, p=0.0077) and anti-HBs geometric mean concentration (GMC) (798.87mIU/ml vs 790.16mIU/ml vs 242.04mIU/ml, p<0.0001) at 7 months. The proportion of infants with anti-HBs greater than 1000mIU/ml was higher in 10μg Hep-KSC than 5μg Hep-KSC group (45.77% vs 11.93%, p<0.0001) at 7 and 12 months. For PM Group, the HBsAg positivity rate in 10μg Hep-KSC and 10μg Engerix-B group was 1.60% and 4.27% at 7 months, respectively. In 10μg Hep-KSC group, 93.61% and 91.29% achieved seroprotection at 7 and 12 months, respectively, and correspondingly 90.24% and 86.96% in 10μg Engerix-B group. The anti-HBs GMC was comparable between 10μg Hep-KSC and 10μg Engerix-B group at 7 and 12 months (575.31mIU/ml vs 559.64mIU/ml; 265.79mIU/ml vs 264.48mIU/ml).
CONCLUSIONS: 10μg Hep-KSC might be appropriate for neonatal immunization with good immunogenicity and efficacy, especially for infants born to HBsAg-positive mothers.
Copyright © 2016. Published by Elsevier Ltd.


KEYWORDS: Hepatitis B vaccine; Immunogenicity; Mother to child transmission; Newborns; Yeast-derived

StephenW

疫苗。 2016年四月23 PII：S0264-410X（16）30196-7。 DOI：10.1016 / j.vaccine.2016.04.042。 [打印EPUB提前]
在健康的婴儿和效率的免疫原性，以防止母亲到10微克重组酵母乙型肝炎疫苗（喉癌KSC）的乙肝病毒的母婴传播。
朱FC1，孙KX2，潘HX1，杨ZH3，卢Y2，梁ZL4，梁XF5，王FZ5，曾Y6，李J7。
传染病的作者信息教研室，江苏省疾病预防控制中心和预防，南京210009，中国。和传染病的微生物教研室中心，基础医学院，北京大学医学部，北京100191，中国。 3Shenzhen康泰生物制品有限公司，深圳518057，中国。 4National研究院食品药品检验所，北京100050，中国。 5Chinese疾病预防中心和预防，北京102206，中国。深圳康泰生物制品有限公司，深圳518057，中国。电子地址：[email protected]。和传染病微生物7Department中心，基础医学院，北京大学医学部，北京100191，中国。电子地址：[email protected]。
抽象
背景和目的：
为了评估为10μg重组酿酒酵母乙肝疫苗（康泰生物制品有限公司，中国深圳）（喉癌KSC）新生儿的免疫原性和有效性。
方法：
母亲所生阴性所生HBsAg阳性母亲（PM集团）乙肝标志物（NM组）和534总的来说1197例患儿参与。在NM组患儿分别给予10微克的Hep-K​​SC，10微克的Engerix-B或5μg的喉癌KSC和那些在PM组接受10微克的Hep-K​​SC或10微克的Engerix-B在0,1和6个月，另外还有200IU HBIG出生后者。
结果：
对于NM组，10微克的Hep-K​​SC并联为10μg的Engerix-B，而优于关于seroprotective速率为5μg的Hep-K​​SC（95.06％对94.83％和89.67％，p值= 0.0077）和抗HBs几何平均浓度（GMC）（798.87mIU / ml对790.16mIU / ml对7个月242.04mIU /毫升，p <0.0001）。具有抗-HBs超过1000mIU / ml的婴儿比例是10微克的Hep-K​​SC比7和12个月为5μg的Hep-K​​SC组（45.77％比11.93％，P <0.0001）高。对于PM集团，在10微克的Hep-K​​SC和10微克的Engerix-B组的HBsAg阳性率分别为1.60％和4.27％，为7个月。在10微克的Hep-K​​SC基，93.61％和91.29％，在第7和12个月分别达到的血清保护，并且相应地90.24％，而在为10μg的Engerix-B组86.96％。抗-HBs GMC为10μg的Hep-K​​SC和10μg的的Engerix-B组之间可比在7和12个月（575.31mIU / ml对559.64mIU /毫升; 265.79mIU / ml对264.48mIU / ml）中。
结论：
10微克的Hep-K​​SC可能适用于具有良好的免疫原性和有效性新生儿免疫接种，特别是对出生HBsAg阳性母亲的婴儿。
版权所有©2016年出版公司爱思唯尔
关键词：
乙肝疫苗;免疫原性;母婴传播;新生儿;酵母来源