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Lancet：新型单价口服脊髓灰质炎病毒疫苗安全性及效果研究

2019-07-13 MedSci MedSci原创

脊髓灰质炎OPVIPV
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新型单价口服脊髓灰质炎病毒疫苗具有极高的安全性及免疫原性

口服减毒脊髓灰质炎疫苗(OPV)和注射灭活脊髓灰质炎疫苗(IPV)是目前最为常用的脊髓灰质炎治疗手段。为了进一步降低因疫苗导致的患病风险，近日研究人员评估一种新型单价口服脊髓灰质炎病毒(Opv 2)疫苗的安全性和免疫原性。

本次研究为I期临床研究，18-50岁的健康志愿者参与，先前接受过IPV。参与者随机接受1剂量候选疫苗（S2/cre5/S15domV/rec1/hifi3或S2/S15domV/CpG40）。研究的主要终点为任何不良事件。

30名志愿者参与研究，2种候选疫苗均可实现免疫原性，并提高血清中和抗体的中位血滴度；所有参与者接种疫苗后都受到血清保护。疫苗具有可接受的耐受性，在研究期间没有发生严重的不良事件。但，6名(40%)接受候选疫苗1和9名(60%)接受候选疫苗2的参与者报告了不良事件，主要是血肌酐磷酸激酶升高，但没有伴随临床症状。15例(100%)接受疫苗候选1的参与者和13例(87%)接受候选疫苗2的参与者粪便中检出疫苗病毒。转基因小鼠验证候选疫苗神经毒性较低。

研究认为，新型单价口服脊髓灰质炎病毒疫苗具有极高的安全性及免疫原性。

原始出处：


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    2019-11-16 howi

    #Lancet#

    0

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    2020-04-14 lixiao3326

    #脊髓灰质炎病毒#

    0

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    2019-07-16 huagfeg

    #病毒疫苗#

    0

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    2019-07-15 12498c32m70暂无昵称

    #脊髓灰质炎#

    0

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    2019-07-13 CHANGE

    疗效只是效果的众多方面之一，还要看对患者的获益，包括生活质量等因素共同决定效果的

    0

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