meili 发表于 2022-10-18 21:53:40

我国又一新冠灭活疫苗临床试验揭盲 无一例严重不良反应

<p>6月16日,由国药集团中国生物武汉生物制品研究所研制的全球首款新冠病毒灭活疫苗Ⅰ/Ⅱ期临床试验盲态审核暨阶段性揭盲会,在北京、河南两地同步举行。</p><p> 国药中国生物的一名工作人员在处理试验疫苗样本国药中国生物6月16日宣布,其新冠病毒灭活疫苗Ⅰ/Ⅱ期临床试验在接种的志愿者身上表现出良好的安全性和有效性,受试者无一例严重不良反应。</p><p>国药中国生物介绍,此次新冠灭活疫苗临床试验为随机<span word="The">The</span> <span word="company">company</span> <span word="said">said</span> <span word="a">a</span> <span word="total">total</span> <span word="of">of</span> 1,120 <span word="volunteers">volunteers</span> <span word="were">were</span> <span word="vaccinated">vaccinated</span> <span word="during">during</span> <span word="the">the</span> <span word="phase">phase</span>-1 <span word="and">and</span> <span word="phase">phase</span>-2 <span word="clinical">clinical</span> <span word="trials">trials</span>, <span word="all">all</span> <span word="of">of</span> <span word="whom">whom</span> <span word="produced">produced</span> <span word="high">high</span>-<span word="titer">titer</span> <span word="antibodies">antibodies</span>.</p><p>国药中国生物介绍,Ⅰ/Ⅱ期临床研究受试者共1120人,疫苗组接种者均产生高滴度抗体。</p><p><span word="In">In</span> <span word="the">the</span> 18-<span word="to">to</span>-59-<span word="year">year</span>-<span word="old">old</span> <span word="age">age</span> <span word="group">group</span>, <span word="those">those</span> <span word="who">who</span> <span word="got">got</span> <span word="two">two</span> <span word="doses">doses</span> <span word="of">of</span> <span word="vaccine">vaccine</span> <span word="based">based</span> <span word="on">on</span> <span word="the">the</span> 0-<span word="and">and</span>-28-<span word="day">day</span> <span word="procedure">procedure</span> <span word="demonstrated">demonstrated</span> 100 <span word="percent">percent</span> <span word="antibody">antibody</span> <span word="positive">positive</span> <span word="conversion">conversion</span> <span word="rate">rate</span>, <span word="while">while</span> <span word="those">those</span> <span word="who">who</span> <span word="got">got</span> <span word="two">two</span> <span word="doses">doses</span> <span word="based">based</span> <span word="on">on</span> <span word="the">the</span> 0-<span word="and">and</span>-14-<span word="day">day</span> <span word="procedure">procedure</span> <span word="and">and</span> 0-<span word="and">and</span>-21-<span word="day">day</span> <span word="procedure">procedure</span> <span word="showed">showed</span> <span word="a">a</span> 97.6 <span word="percent">percent</span> <span word="antibody">antibody</span> <span word="positive">positive</span> <span word="conversion">conversion</span> <span word="rate">rate</span>.</p><p>在18—59岁健康受试者中,按照0/28天程序接种两剂后,受试者中和抗体阳转率达100%。按照0/14天和0/21天程序接种后的受试者中和抗体阳转率为97.6%。</p><p>专家表示,</p><p><span word="The">The</span> <span word="results">results</span> <span word="were">were</span> <span word="the">the</span> <span word="world">world</span>'<span word="s">s</span> <span word="first">first</span> <span word="clinical">clinical</span> <span word="data">data</span> <span word="on">on</span> <span word="safety">safety</span> <span word="and">and</span> <span word="effectiveness">effectiveness</span> <span word="collected">collected</span> <span word="after">after</span> <span word="two">two</span> <span word="doses">doses</span> <span word="of">of</span> <span word="vaccination">vaccination</span>, <span word="offering">offering</span> <span word="scientific">scientific</span> <span word="and">and</span> <span word="measurable">measurable</span> <span word="support">support</span> <span word="for">for</span> <span word="epidemic">epidemic</span> <span word="prevention">prevention</span> <span word="and">and</span> <span word="control">control</span> <span word="and">and</span> <span word="emergency">emergency</span> <span word="use">use</span>.</p>
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