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“马赛克疫苗使HIV灭绝”系误读 数据源自动物试验
艾滋病临床专家、北京协和医院感染科主任李太生表示,不应把两组实验数据混为一谈,“把这两个概念合到一起,称人100%出了抗体而且保护率有多少多少。猴子和人的差别太大了。不懂的人一看‘100%’和‘94%’。疫苗来讲,最重要是保护率。这个抗体关键有没有保护性作用,是不是综合性抗体,尤其有没有产生特异性的细胞免疫,这是关键。疫苗从1986年开始已经做了30年了,没有一个有效疫苗。”
疫苗从基础研发到最后上市,消费者可以使用,需要完成临床前的动物试验以及早期人体临床试验等一些列的临床验证。
专家:目前评价疫苗有保护作用尚早
基于这项研究目前发布的成果内容,吴尊友表示,就项目本身而言,其取得了进展。但是,目前距离评价疫苗能否起到保护作用,能不能用,还太早,“到临床Ⅲ期才能真正评价它的效果。临床Ⅰ期、Ⅱ期主要是做它的安全性和能否产生抗体。能产生抗体说明能产生免疫反应。从研究本身来说,它的疫苗取得了进展。如果疫苗连抗体都没有,基本上就没有往前走的必要了。有抗体可以继续往前走,但后面的路还很长。它能不能起到保护作用,能不能用,现在评价还是太早。”
据了解,“Approach”项目更大规模的临床试验正在计划中,如果顺利的话,会于2017年年末或2018年年初展开试验。
那么,HIV疫苗,离我们还有多远?
对此,吴尊友指出,这不好预测,但从目前全球研究来看,5年内不会出现,“就简单的一个Ⅲ期临床试验都要5年的时间。就是疫苗理论已经可以了,要看看实际有没有效果,这样一个临床试验没有5年做不下来。何况现在还没有疫苗呢。所以,应该说是不可预测。如果非要说,5年以内不可能有疫苗。在艾滋病研究方面,更多的研究进展还是一种新药的问世和药品的新应用。2017年在全球范围内,已经有7个新药注册了。”
本报道线索由腾讯较真平台提供。
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