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Nano Covax新冠疫苗三期人体试验 为1.2万名志愿者接种第二针

2021-07-27 18:11

Nano Covax新冠疫苗三期人体试验 为1.2万名志愿者接种第二针。

(人民报)据越南国防部军医学院的消息,在完成为Nano Covax新冠疫苗三期人体试验(3a期)1000名志愿者第二针接种工作后,27日上午,参与 Nano Covax新冠疫苗三期人体试验(3b期)的各单位将继续为1.2万名志愿者接种第二针。

军医学院生物等效性与临床试验中心主任渚文敏中校、副教授、表示,在进行试验接种前,志愿者需进行健康申报,进行生命体征测试以及对志愿者进行一系列有关检查。1.2万名志愿者按照2:1:1的比例随机分配疫苗或安慰剂,接种剂量分别为25mcg,其中2人注射疫苗,1人注射安慰剂。

此前,7月14日,1.3万名志愿者(3a期和3b期)已完成Nano Covax新冠疫苗第一针接种,其后,22日,3a期1000名志愿者已完成Nano Covax新冠疫苗第二针接种,健康状况稳定,没有出现预料之外的反应。

Nano Covax新冠疫苗三期人体试验在全国许多中心进行。

Nano Covax是越南进行人体临床试验的首款新冠疫苗,由药用生物技术有限责任公司(Nanogen)自2020年5月开始研发。进入三期试验之前,这款疫苗已完成两期人体临床试验;一期试验于2020年12月18日启动,二期试验于2021年2月26日启动,三期试验于2021年6月11日正式开始。

新冠疫苗Nano Covax的三期人体临床试验工作旨在评估这款疫苗的保护效力,志愿者人数多达1.3万人,分成2个研究组,即低剂量疫苗组(射剂量为25mcg)和安慰剂对照组。前两期试验结果表明,所有志愿者体内均产生良好免疫效果,血清转化率超过99%。(完)

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