June 16, New Coronavirus Inactivated Vaccine Phase I/II Clinical Trial developed by Sinopharm Wuhan Institute of Biological Products Blind review and phased unblinding meeting in Beijing and Henan The two places are held simultaneously. Experts from the State Council's Joint Prevention and Control Mechanism Vaccine Class and the Biotechnology Development Center of the Ministry of Science and Technology attended.
Unblind results show:
After vaccination, the safety is good
No serious adverse reactions
0d9ed after vaccination with different procedures and different doses#
All vaccinators in the vaccine group produced high-titer antibodies
28-day program after two doses
Neutralizing antibody positive conversion rate reached 100%
The new crown inactivated vaccine clinical trial of Wuhan Institute of Biological Products is a randomized, double-blind, placebo-controlled phase I/II clinical study. On April 12, , the new crown inactivated vaccine, was the first company in the world to obtain clinical trial approval . Phase I/II clinical trials were started simultaneously in Wuzhi County, Henan Province.
Under the leadership of the Henan Provincial Center for Disease Control and Prevention, the clinical trial site has overcome the difficulties caused by the epidemic, and fought continuously 66天, The world's first inoculation of the new crown inactivated vaccine with 2 injections The subsequent safety and efficacy data , the research results of different ages, different procedures, different doses, and different injection times are presented relatively completely. This is also the clinical research result with the longest time, the most comprehensive data, and the most ideal effect so far. It provides scientific and evaluable data for my country's epidemic prevention and control and emergency use.
This study aims to evaluate the use of inactivated new crown vaccine in healthy subjects aged 18-59, according to low, medium, and high doses and 0,14,0,21 The safety and immunogenicity after vaccination with 0,28 different procedures, focusing on the changes in cellular immunity after vaccination, and exploring the changes in vaccination procedures, immunization dose, safety, immunogenicity and antibody levels in the body trend. Up to now, there are 1120 subjects in the Phase I/II clinical study, and all of them have completed 2 injections of .
This clinical trial program has been carefully designed, and the unblinding process strictly follows scientific and rigorous results. The results are encouraging. is safe and effective after vaccination. All subjects in the vaccination group produced high-titer antibodies , the positive conversion rate of neutralizing antibody after two doses in the 18-59-year-old group according to the procedures of 0,14 and 0,21 days reached 97.6%, and the positive conversion rate of two doses of neutralizing antibodies was administered according to the procedure of 0,28 days Up to 100%.
Zhao Dongyang, Deputy Director of Henan Provincial Center for Disease Control and Prevention, Xia Shengli, researcher, Professor Shi Xuezhong and Professor Yang Yongli, School of Public Health, Zhengzhou University, Zhu Jingjin, Secretary of the Party Committee of China Biology, President Wu Yonglin, Chief Financial Officer Hu Ligang, Vice President Zhang Yuntao, Clinical Medicine Yang Yunkai, deputy director of the center, Li Xinguo, deputy general manager of Wuhan Institute of Biological Products, chief scientist Shen Shuo, and Wang Zejun, director of the first virus room, attended the unblinding ceremony. The Wuzhi County Center for Disease Control and Prevention, Henan Hengyi and other cooperative organizations jointly witnessed this.
At the same time, Sinobio actively promotes overseas cooperation in Phase III clinical trials, and has confirmed cooperation intentions with companies and institutions in many countries. China Biotech has taken the lead in building a high-level biosafety production workshop, which is currently the only new crown vaccine production workshop in the world that meets biosafety and GMP standards and can meet emergency vaccination needs in quantity.
The epidemic prevention and control situation is still complicated and severe, and the prevention and control of the new crown epidemic through vaccines is imminent. The safety and effectiveness data of this unblinding greatly strengthened our confidence in winning the final victory in the battle against the epidemic prevention and control.The availability and affordability of vaccines as a global public product provide strong support and make China's contribution.
Source: Inner Sinopharm Group China Biotech
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