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历经三十年的研发 艾滋病疫苗离上市还有多远?
2017-09-15 13:16:51 中国青年网
新的希望
尽管RV144临床试验没有取得理想效果,但是给研究人员带来新的希望和启发。
一个由美国国家过敏症与传染病研究所、盖茨基金会、美国军方HIV研究项目、法国赛诺菲公司、美国HIV临床网络、瑞士诺华公司等机构联合组建的合作组织,在RV144临床试验基础上开展了很多改进研究,针对南非常见的艾滋病病毒C亚型,对所用疫苗、加强免疫程序进行了多处调整,形成了新的免疫方案。该免疫方案于2015年完成了临床I/IIa临床试验,除了采用免疫效果更好的疫苗,还将免疫时间从半年延长到一年,强化免疫也增加了一次,同时增加一个免疫强化剂,结果显示该免疫方案能引发机体对艾滋病病毒C亚型产生免疫反应,效果不低于RV144。
经过评估,该合作组织2016年底启动了该免疫方案的有效性临床试验,代号为HVTN 702,计划在南非招募5400名志愿者,年龄18岁到35岁,在一年内接受5次免疫注射,预计到2020年结束。研究人员希望通过上述调整,能增加疫苗效价,提高疫苗密度,并延长疫苗作用时间,以期引发更强的免疫反应,产生更多的中和抗体,以提升该免疫方案的免疫效果,至少与RV144临床试验中免疫一年时的保护率60%相当。
除了这些临床试验,该联合攻关组织还准备了多项新的免疫方案,其安全性临床试验均已陆续开展。其它多个研究机构也加入到艾滋病疫苗的研发中,强生公司所设计的疫苗则是一种更新颖的马赛克疫苗,即把两种不同艾滋病病毒亚型的多种抗原集中在一种疫苗上,临床前试验显示,该疫苗可将猕猴单次暴露猕猴艾滋病病毒的感染风险降低94%,而6次暴露后,保护率仍可达66%。安全性临床试验则表明该疫苗具有良好的耐受性,并能让受试者都产生免疫反应。
虽然过去30年的努力,证明艾滋病疫苗研发不会一蹴而就,但是随着科学家们对艾滋病病毒特点、人体免疫系统与病毒相互作用机制等方面了解得愈发透彻,艾滋病疫苗一定能研制成功。在此之前,艾滋病疫苗研发的任何重大进展,都值得期待。
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