rojjer 发表于 2016-8-4 16:05:10

美国启动寨卡疫苗人体临床试验(附临床试验概况)

      寨卡病毒成为世界性的威胁,各国的科学家与研究人员都在希望自己能为防治寨卡病毒奉献一丝力量。美国政府卫生机构3日宣布启动一种试验性寨卡疫苗的一期临床试验,以评估这种疫苗的安全性以及引发人体免疫反应的能力。
  美国国家卫生研究院当天发表声明说,这种疫苗由其下属机构国家过敏症和传染病研究所研制,将在至少80名18岁至35岁的健康志愿者身上测试,其中一半人将注射2剂疫苗,另一半人注射3剂疫苗。试验将在国家卫生研究院位于马里兰州贝塞斯达的总部、马里兰大学医学院和埃默里大学3处地点进行。
  美国国家过敏症和传染病研究所所长安东尼·福奇指出,研制安全有效的寨卡疫苗是“紧迫的公共卫生需求”,启动人体临床试验是“向前迈出的重要一步”。
  与传统疫苗不一样的是,这种寨卡疫苗是一种DNA(脱氧核糖核酸)疫苗,它包含被称为质粒的一小段环状DNA片断。当疫苗被注射到肌肉细胞中后,细胞会读取质粒基因,编码产生寨卡病毒蛋白质,这些蛋白质会自我组装成类似寨卡病毒的粒子,引起机体免疫反应。在动物实验中,这种疫苗已显示出“令人十分鼓舞”的效果。
  美国国家卫生研究院说,初步的安全性和免疫反应数据预计明年1月可以获得。如果结果符合预期,那么明年年初将在寨卡病毒流行国家开展更大规模的二期临床试验。
  这是美国的第二个寨卡疫苗人体临床试验。上月,美国食品和药物管理局批准美国伊诺维奥制药公司招募40名健康志愿者,开展另一种寨卡疫苗的一期临床试验。
  自去年以来,寨卡病毒在巴西等美洲国家持续肆虐。绝大多数寨卡病毒感染者症状温和,但公众主要担心寨卡病毒导致新生儿小头症。目前尚无针对寨卡病毒的有效治疗方法和疫苗。

rojjer 发表于 2016-8-4 16:08:20

Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults(NCT02840487)

Estimated Enrollment:120(18 Years to 35 Years)
Study Start Date:July 2016
Estimated Study Completion Date:December 2018
Estimated Primary Completion Date:December 2017 (Final data collection date for primary outcome measure)

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查看完整版本: 美国启动寨卡疫苗人体临床试验(附临床试验概况)