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JAMA:对2种埃博拉病毒疫苗安全性和免疫原性的评价

2016-04-20 MedSci MedSci原创

研发有效的疫苗来对抗埃博拉病毒是全世界优先要做的一个事情。本研究旨在评估评估2种埃博拉病毒候选疫苗的耐受性和免疫原性:编码的埃博拉病毒糖蛋白的腺病毒型26载体疫苗(Ad26.ZEBOV)和编码埃博拉病毒、苏丹病毒、马尔堡病毒和大森林病毒核蛋白的糖蛋白的改良安卡拉载体疫苗(MVA-BN-Filo)。

研发有效的疫苗来对抗埃博拉病毒是全世界优先要做的一个事情。本研究旨在评估评估2种埃博拉病毒候选疫苗的耐受性和免疫原性:编码的埃博拉病毒糖蛋白的腺病毒型26载体疫苗(Ad26.ZEBOV)和编码埃博拉病毒、苏丹病毒、马尔堡病毒和大森林病毒核蛋白的糖蛋白改良安卡拉载体疫苗(MVA-BN-Filo)。

在此单中心、随机、安慰剂对照、双盲1期临床试验中,研究人员招募了87名年龄在18-50岁的健康人,随访8个月。

参与者随机分为4组,同时以5:1的比例随机接受研究疫苗或安慰剂。接受活性疫苗者预先接种了Ad26.ZEBOV 或 MVA-BN-Filo,并在此后的28天或56天后接受了另一种疫苗以增强接种。第5组为非盲组预先接种Ad26.ZEBOV并在14天后再次接受MVA-BN-Filo增强接种。

主要结果为安全性和耐受性。记录所有的不良反应事件,直到每次免疫后21天,但是整个试验中都要记录严重不良反应事件。次要结果为机体的体液免疫和细胞免疫,基线时期和每次免疫后7天采用酶联免疫吸附测定法和酶联免疫斑点实验进行评估,直至启动免疫后8个月。

87名参与者的平均年龄为38.5岁, 66.7%的参与者为女性,其中72名参与者被随机分为4组,每组18名,其余 15名参与者分到非盲组。4名参与者没有接受增强接种;75名参与者中的67名随访了8个月。

整个试验中无疫苗相关严重不良反应事件发生。患者接种MVA-BN-Filo后并没有出现发热者,而60名接种Ad26.ZEBOV的参与者中有3名出现了发热。非盲组中15名接种 Ad26.ZEBOV的参与者中共有4名出现了发热。

随机分组中,29名接种 Ad26.ZEBOV的参与者共有28名可在初次接种后的28天检测到埃博拉病毒糖蛋白特异性IgG,而30名接种MVA-BN-Filo的参与者中共有7名可检测到。8个月的随访期间,所有接种疫苗的参与者均可在增强接种后21天检测到特异性IgG。随机分组中,增强接种后7天, 86%以上的疫苗接种者出现埃博拉病毒特异性T细胞反应。

在接受Ad26.ZEBOV的最初接种后看到了免疫反应,而用MVA-BN-Filo进行增强接种则可产生持续升高的特异性免疫力。用Ad26.ZEBOV 或 MVA-BN-Filo进行接种没有产生任何与疫苗相关的严重不良反应。

总而言之,在这1期健康志愿者的研究中,Ad26.ZEBOV 或 MVA-BN-Filo免疫并不会导致任何疫苗相关的严重不良反应事件的发生。预先接种Ad26.ZEBOV可产生一种初步免疫反应;使用MVA-BN-Filo的增强接种可产生持续的特异性免疫的升高。2期和3期研究将进一步评估这些疫苗。

原始出处:

Iain D. Milligan, Malick M. Gibani, et al., Safety and Immunogenicity of Novel Adenovirus Type 26– and Modified Vaccinia Ankara–Vectored Ebola VaccinesA Randomized Clinical Trial. JAMA. 2016;315(15):1610-1623. doi:10.1001/jama.2016.4218.

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    2016-04-25 1deb5047m95(暂无匿称)

    早点看到二期研究

    0

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    2016-04-22 huagfeg
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