武田登革热疫苗在大规模的3期临床试验中有效率达80%

2019-11-07 不详 MedSci原创

在名为"Tides"的临床研究中,研究人员在拉丁美洲和亚洲的登革热流行国家对2万名年龄在4至16岁的参与者中进行了武田制药疫苗TAK-003的测试。接种疫苗的人数是接受安慰剂的人数的两倍。

武田在登革热疫苗计划上花费了大量时间、精力和金钱,现在这家日本制药巨头宣布了令人鼓舞的第三阶段数据。

在名为"Tides"的临床研究中,研究人员在拉丁美洲和亚洲的登革热流行国家对2万名年龄在4至16岁的参与者中进行了武田制药疫苗TAK-003的测试。接种疫苗的人数是接受安慰剂的人数的两倍。

研究小组在周三报告说,疫苗的有效率达80.2%。重要的是,登革热血清型的疗效各不相同。该疫苗对登革热血清型1有效率为73.7%,对血清型2有效率为97.7%,对血清型3有效为62.6%。研究人员没有追踪足够的血清型4病例,无法确定疗效。

预防需要住院的登革热感染中,该疫苗有效率为95.4%;疫苗组有5例住院,而安慰剂组有53例。该公司表示,预计第三阶段的研究将成为提交监管文件的基础。

武田公司登革热疫苗项目负责人德里克·华莱士(Derek Wallace)告诉FiercePharma,该公司"受到数据的鼓舞",因为结果表明该疫苗"对全球登革热负担具有巨大影响"。

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