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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

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
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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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