我國又一新冠滅活疫苗臨床試驗揭盲 無一例嚴重不良反應

6月16日，由國藥集團中國生物武漢生物制品研究所研制的全球首款新冠病毒滅活疫苗Ⅰ/Ⅱ期臨床試驗盲態(tài)審核暨階段性揭盲會，在北京、河南兩地同步舉行。

國藥中國生物的一名工作人員在處理試驗疫苗樣本(圖片來源：新華社)

China National Biotech Group Co Ltd announced on Tuesday the phase-1 and phase-2 clinical trials of its inactivated vaccine had demonstrated good performance in safety and effectiveness on vaccinated volunteers. No subjects showed serious adverse reactions, the company said.

國藥中國生物6月16日宣布，其新冠病毒滅活疫苗Ⅰ/Ⅱ期臨床試驗在接種的志愿者身上表現(xiàn)出良好的安全性和有效性，受試者無一例嚴重不良反應。

國藥中國生物介紹，此次新冠滅活疫苗臨床試驗為隨機(random trial)、雙盲(double-blind trial)、安慰劑對照(placebo-controlled trial)的Ⅰ/Ⅱ期臨床研究。

The company said a total of 1,120 volunteers were vaccinated during the phase-1 and phase-2 clinical trials, all of whom produced high-titer antibodies.

國藥中國生物介紹，Ⅰ/Ⅱ期臨床研究受試者共1120人，疫苗組接種者均產(chǎn)生高滴度抗體。

In the 18-to-59-year-old age group, those who got two doses of vaccine based on the 0-and-28-day procedure demonstrated 100 percent antibody positive conversion rate, while those who got two doses based on the 0-and-14-day procedure and 0-and-21-day procedure showed a 97.6 percent antibody positive conversion rate.

在18—59歲健康受試者中，按照0/28天程序接種兩劑后，受試者中和抗體陽轉(zhuǎn)率達100%。按照0/14天和0/21天程序接種后的受試者中和抗體陽轉(zhuǎn)率為97.6%。

專家表示，

The results were the world's first clinical data on safety and effectiveness collected after two doses of vaccination, offering scientific and measurable support for epidemic prevention and control and emergency use.

這也是全球首個接種兩劑疫苗后收集到的臨床安全性及有效性數(shù)據(jù)，為疫情防控和緊急使用提供了科學、可評價的數(shù)據(jù)。

國藥中國生物同時透露，正積極推進Ⅲ期臨床研究的海外合作。

It has received cooperation overtures from companies and institutions overseas. Once the inactivated vaccine completes the three trials, it is expected to hit the market by the end of this year or the beginning of next year.

該公司已經(jīng)收到了海外幾家公司和機構(gòu)的合作意向。滅活疫苗完成三期試驗之后，有望于今年年底或明年初面市。

國務院新聞辦公室6月7日發(fā)布的《抗擊新冠肺炎疫情的中國行動》白皮書指出，

To date, four inactivated vaccines and one adenovirus vaccine have been approved for clinical trials. While scientists in China and abroad have kept up with mutual developments, China leads the world in the development of certain types of vaccines.

目前，已有4種滅活疫苗和1種腺病毒載體疫苗獲批開展臨床試驗，總體研發(fā)進度與國外持平，部分技術(shù)路線進展處于國際領(lǐng)先。

【相關(guān)詞匯】

臨床試驗

clinical trial

臨床前研究

preclinical research

動物試驗

animal test

毒性試驗

toxicology test

有效性和安全性研究

safety and efficacy research

免疫系統(tǒng)

immune system

疫苗臨床試驗和上市使用

clinical trial and application of vaccines