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艾滋病疫苗真的已经来了?这是一场媒体的误导和公众的误读

2017-08-10 09:14:53   中国青年网

“我们对抗艾滋病毒保护性免疫反应的认识还很不完整,现在无法确定其诱导出来的抗体反应是否具有保护作用,需要更大量的人体试验来研究和分析。”张林琦说,对这款疫苗有效性的最终评价,“需要至少5-10年的时间,才能见分晓”。

不管是药物还是疫苗,从基础研发到最后与消费者见面,需要完成临床前的动物试验,以及从1期、2a期的早期人体临床试验一直到2b期、3a期、3b期的临床验证。目前,杨森制药公司完成的尚是早期的1期、2a期,其有效性、安全性等还有待之后几期临床试验的考验。

据美国国立卫生研究院过敏与感染研究所(NIAID)报道, 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年末或2018年初,在南非招募2600名健康的女性展开试验。

释点2:“单次暴露于艾滋病病毒下感染风险减少了94%”

真相:不是人体临床试验,是4年前猴子身上的试验结果

据媒体报道,这次临床试验“除了在受试者身上100%产生了抗御HIV病毒的抗体外,还让受试者单次暴露于艾滋病病毒(HIV)下感染风险减少了94%,并且有66%的人在6次暴露于HIV下仍然受到保护,没被HIV感染。”

如果在人体临床试验中,APPROACH研究的数据真如上所述,这的确是一件令人鼓舞的事。要知道,在2009年,美国国防部联合泰国官方,曾开展过另一种艾滋病疫苗“RV144”的大规模临床试验,参与人数达1万余人。RV144疫苗在最终的3期临床试验中降低了31%的艾滋病毒感染率,这已经是目前在艾滋病疫苗临床试验中最高的保护力。

但事实上,该种疫苗“在单次暴露中减少94%感染风险、6次暴露中减少66%感染率”的数据并不是来自此次杨森制药公司的人体临床试验,而是来自临床前的动物试验。

美国哈佛大学医学院教授Dan H. Barouch及其团队是APPROACH研究的技术铺垫者,是他们团队开发出了此次被测疫苗的前身——一种拼接多种艾滋病病毒亚型基因的“马赛克疫苗”。

在2013年,Barouch团队就在恒河猴上进行这种“马赛克疫苗”的动物试验。为了模拟艾滋病毒(HIV),试验用的猴子被暴露在SHIV病毒下。SHIV病毒可以在动物身上引发类艾滋病。而那场动物试验,便是“在单次暴露中减少94%感染风险、6次暴露中减少66%感染率”的数据来源。

在恒河猴的试验中得到令人激动的数据,在人体临床试验中是否也会有一样的惊喜?至少现在,我们还无法得知。

“HIV疫苗人体临床试验的保护力则需要在疫苗临床试验全部完成,甚至完成数年后才能获悉。”王宇歌写道。

这种潜在艾滋病疫苗在动物试验上交出了漂亮成绩单,在人类苦苦寻找有效艾滋病疫苗的路上,它在下一步大规模人体试验中的表现依然值得期待。

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