Immunogenicity and safety of inactivated chromatographically purified Vero cell-derived Japanese encephalitis vaccine in Thai children

Immunogenicity and safety of inactivated chromatographically purified Vero cell-derived Japanese encephalitis vaccine in Thai children
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DOI:
10.1080/21645515.2017.1414763
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发表时间:
2018-01-01
影响因子:
4.8
通讯作者:
Zhumu, Bai
Zhumu, Bai
中科院分区:
医学3区
文献类型:
--
作者:
Chanthavanich, Pornthep;Limkittikul, Kriengsak;Zhumu, Bai

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小鼠脑源性乙型脑炎灭活疫苗安全性令人担忧,减毒活疫苗不适合免疫缺陷。本研究旨在评价层析纯化的灭活vero细胞来源的乙脑疫苗(cvi -乙脑,北京P-3株)在儿童中的免疫原性和安全性。152名健康的泰国儿童,平均(SD)年龄为14.4(3.8)个月,分别在第0天、第7-28天和第1年接受了3剂cvi -乙脑疫苗。测定同源乙脑中和抗体滴度(NT)。所有受试者在第二次接种后28天均有血清保护[几何平均滴度(GMT) 150]。初次接种后1年和加强后1个月的血清保护率分别为89.3% (GMT 49)和100% (GMT 621)。在接种疫苗后28天内发现了局部和全身反应——发烧(17.6%)、呕吐(8%)和食欲不振(5.3%)。所有这些症状都是自限性的。结论:cvi -乙脑是安全的,具有免疫原性,并提供高NT。
Inactivated mouse-brain-derived Japanese encephalitis vaccine has a worrisome safety profile and the live attenuated vaccine is unsuitable in immunodeficiency. This study aimed to evaluate the immunogenicity and safety of an inactivated chromatographically purified Vero-cell-derived JE vaccine (CVI-JE, Beijing P-3 strain) in children.152 healthy Thai children, with an average (SD) age of 14.4 (3.8) months, received 3 doses of CVI-JE on days 0, 7-28, and one year. Homologous JE neutralizing antibody titers (NT) were measured. All subjects had seroprotection [geometric mean titer (GMT) 150] 28 days' post 2nd vaccination. The seroprotection rates at 1 year after primary series and and 1 month after the booster were 89.3% (GMT 49) and 100% (GMT 621), respectively. Local and systemic reactions-fever (17.6%), vomiting (8%), and poor appetite (5.3%)-were noted within 28 days' post-vaccination. All these symptoms were self-limited. Conclusions: CVI-JE is safe, immunogenic, and provided high NT.