国药集团中国生物新冠灭活疫苗一二期临床中期结果刊登 有效诱导产生中和抗体
国药集团中国生物於官网公布,昨日(13日)国际医学期刊《美国医学会杂志》刊登了国药集团中国生物武汉生物制品研究所和中国科学院武汉病毒研究所联合研制的新冠灭活疫苗一及二期临床试验中期结果,为全球新冠灭活疫苗第一篇正式发表的临床试验数据文章,该疫苗也是全球第一个被批准进入临床试验的新冠灭活疫苗。
该文章涉及了一及二期18至59岁共320名志愿者的临床试验中期数据。结果表明疫苗能在该年龄组人群中有效诱导产生中和抗体,中和抗体水平也与其他疫苗研究报导的水平相当,证实疫苗具有良好的免疫原性。
在安全性方面,接种疫苗7天内观察到的主要不良反应为注射部位疼痛,其次是发热,但均为轻微和自限式的,不需任何治疗。研究中无任何与疫苗有关的严重不良事件发生。
公告指,除文章已涉及的组别外,一及二期期其余组别的临床试验正在按计划进行。此外,包含更多受试志愿者的三期临床试验在阿拉伯联合酋长国正在开展,将对该疫苗的安全性和有效性试验作进一步评价。
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