AIM:两种新型HIV-1预防疫苗的安全性和免疫原性评价

2016-02-03 MedSci MedSci原创

预防性HIV疫苗是一个全球性的健康优先的选择。该研究的目的是评估一种新型疫苗平台作为预防HIV-1方案的效果。研究人员进行了一项随机性,双盲,安慰剂对照试验,参与者和研究人员都不知道治疗分配。该研究在美国,东非,南非进行。参与者为非HIV感染的年轻成人。干预措施为2种HIV-1疫苗(腺病毒血清型26包含HIV-1 A插入[Ad26.EnvA]和腺病毒血清型35包含HIV-1 A插入[Ad35.En

预防性HIV疫苗是一个全球性的健康优先的选择。该研究的目的是评估一种新型疫苗平台作为预防HIV-1方案的效果。

研究人员进行了一项随机性,双盲,安慰剂对照试验,参与者和研究人员都不知道治疗分配。该研究在美国,东非,南非进行。参与者为非HIV感染的年轻成人。

干预措施为2种HIV-1疫苗(腺病毒血清型26包含HIV-1 A插入[Ad26.EnvA]和腺病毒血清型35包含HIV-1 A插入[Ad35.Env],两种疫苗的剂量均为5×10 e10病毒颗粒)同源和异源的组合。

主要结果为基线向量免疫的安全性和免疫原性及效果。

217名参与者接受至少1次接种疫苗,210(>96%)名完成随访。没有疫苗相关的严重不良事件发生。所有方案的一般耐受性良好。所有方案在几乎所有的参与者中都引起体液免疫和细胞免疫应答。预先存在的Ad26-或Ad35的中和抗体滴度对疫苗安全性和免疫原性没有影响。在同源和异源的方案中,第二次接种显著增加Enva抗体滴度(从30-300到3000的平均酶联免疫吸附滴度检测大约为20倍)。 AD26-Ad35的异源方案比Ad35-AD26引起显著更高的ENVA抗体滴度。东非与南非和美国相比,T细胞的反应是温和的。

两种疫苗在所有人群显著均引起免疫反应。基线向量免疫力没有显著影响反应。在所有的方案第二次接种显著增加了Enva抗体滴度,尽管在异源方案疫苗顺序对免疫应答影响不大。

原始出处:

Baden LR, Karita E, Mutua G,et al.Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention,ANN INTERN MED,2016.2.2

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    2016-02-06 忠诚向上

    有些可信

    0

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    2016-02-05 1de47ca2m12(暂无匿称)

    分享

    0

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    2016-02-05 huagfeg