Phase I/II clinical blindness of new crown vaccine developed by enterprises in this city
The vaccine has good safety and immunogenicity
News from this reporter (reporter Zhang Hang) The new coronavirus inactivated vaccine developed by Beijing enterprises has made new progress! The reporter learned yesterday from Beijing Kexing Zhongwei Biotechnology Co., Ltd. that the Phase I/II clinical study (0,14 procedure) of the new coronavirus inactivated vaccine developed by the company was uncovered. Preliminary results show that the vaccine has good safety and immunogenicity. It is reported that Kexing Zhongwei plans to submit the Phase II clinical research report and Phase III clinical research plan to the State Drug Administration recently, and strive to start the phase III clinical research and vaccine application of the vaccine as soon as possible.
After the outbreak of New Coronary Pneumonia, Beijing Kexing Zhongwei launched the "Corona Action" new coronavirus inactivated vaccine development project on January 28. It was held in the National Vaccine R&D Class, Ministry of Science and Technology, National Health and Health Commission, and State Drug Administration , The Ministry of Industry and Information Technology and other relevant departments and the Beijing municipal government, with the strong support of the company’s inactivated vaccine developed on April 13 was approved for clinical research, and then on April 16 in Jiangsu launched the adult group (18 to 59 years old) Ⅰ /Phase II clinical study.
According to reports, the purpose of this randomized, double-blind, placebo-controlled phase I/II clinical study was to evaluate different doses of new coronavirus inactivated vaccines in accordance with the "0,14 procedure" (subjects received a total of two injections at intervals 14-day vaccination program) or "0,28 program" (subjects received a total of two injections, the vaccination program is performed at intervals of 28 days) The safety, tolerability and immunogenicity of vaccination of healthy subjects to determine the immunization of the vaccine Procedure and immunization dose. Up to now, a total of 743 subjects in Phase I/II clinical studies have completed vaccination. Existing data shows that the vaccine has good safety and immunogenicity.
The safety data of the "0,14 program" Phase I/II clinical study of the blinding show that the adverse reactions of the vaccine are mainly grade 1, mainly manifested as mild pain at the vaccination site, and individual subjects have fatigue and low fever. No serious adverse reaction report. The results of the immunogenicity of the "0,14 program" in the phase II clinical study showed that the positive antibody conversion rate of neutralizing antibodies exceeded 90% after 14 days of full immunization, indicating that the vaccine has good immunogenicity.
It is reported that Kexing Zhongwei plans to submit Phase II clinical research reports and Phase III clinical research programs to the State Drug Administration recently, striving to start Phase III clinical research and vaccine applications as soon as possible, with a view to using vaccines as a global public product in disease prevention as soon as possible The role of control will contribute to China and the global response to the new crown epidemic.