2018年全球疟疾感染死亡40万例,美国国立卫生研究院即将开展抗疟疾单抗CIS43LS的首次临床试验

2020-02-02 不详 MedSci原创

美国国立卫生研究院(NIH)临床中心的科学家们已经开始了一项1期临床实验,以研究这种称为CIS43LS的单克隆抗体是否可以预防健康人类志愿者中的疟疾感染。

美国国立卫生研究院(NIH)临床中心的科学家们已经开始了一项1期临床实验,以研究这种称为CIS43LS的单克隆抗体是否可以预防健康人类志愿者中的疟疾感染

该试验将招募约73名18至50岁的成年人,这些成年人过去从未感染过疟疾。用三种剂量的抗体(5、20和40 mg / kg)干预后,志愿者将在受控条件下暴露于携带恶性疟原虫的蚊子下,以观察药物是否可以预防感染。结果应该在明年第一季度公布。

美国国家过敏和传染病研究所(NIAID)所长Anthony Fauci评论说,如果证明是有效的,该抗体有望用于保护"前往疟疾流行地区的游客、医务人员或军事人员"。

由葛兰素史克(GlaxoSmithKline)开发的一种名为Mosquirix(RTS,S/AS01)的重组疟疾疫苗,在经过三十年的研究后于2015年被EMA给予了积极的评价,但被认为疗效有限。

尽管如此,它仍被世界卫生组织(WHO)在撒哈拉以南非洲中等至高度疟疾传播地区试点使用,重点是加纳、马拉维和肯尼亚的幼儿,因为即使是适度的疗效也可能产生有益的影响。

在一项3期试验中,对5至17个月大的孩子服用四剂Mosquirix的预防功效为39%,但似乎也可以保护他们免受严重疟疾的侵袭。

Fauci说:"在缺乏高效持久疫苗的情况下,用单剂量的单克隆抗体预防疟疾感染数月也可能对非洲特定地区产生价值。疟疾病例在每年的雨季中大大增加。"

该疫苗是由Robert Seder领导的NIAID研究人员几年前开发的,从志愿者血液中获取的抗体,该志愿者接受了由完整的弱化疟原虫制成的研究性疫苗。

根据世界卫生组织的数据,2018年全世界有2.28亿疟疾病例,造成405000例死亡。

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