Interview with Kexing New Crown Inactivated Vaccine R & D Party: Dozens of volunteers have been vaccinated in Phase I clinical trials
Three domestic new coronavirus vaccines have been approved for clinical trials.
These include the new inactivated coronavirus vaccine Kerrford ™ developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. (hereinafter referred to as Kexing Zhongwei), a subsidiary of Kexing Holding Biotechnology Co., Ltd. (hereinafter referred to as Kexing). On April 16, the Phase I clinical study of the vaccine was launched in Suining County, Xuzhou City, Jiangsu Province, and the first batch of volunteers successfully completed the vaccination.
On April 17, Peng Mei News (www.thepaper.cn) interviewed Xue Jie, the chairman of the Kexing Quality Management Committee and the head of the quality and registration of the Kexing New Crown Inactivated Vaccine Development Project. According to her, Kexing is the sponsor of this vaccine clinical trial research, and the researcher is the Jiangsu Provincial Center for Disease Control.
She said that as of now, dozens of volunteers have completed the vaccination in the Phase I clinical trial. Each person received 2 doses of vaccine or placebo control, followed by a 30-minute safety observation. The preliminary results show that the vaccine is safe. Volunteers will receive safety visits from researchers on days 1, 2, 3, 4, 7, and 30 after inoculation.
According to Gong Xuejie, the phase I clinical trial mainly evaluates the safety of the vaccine, the phase II evaluates the safety and effectiveness, and the phase III will also further evaluate the effectiveness of the vaccine. At present, Kexing Zhongwei has started the construction of new crown vaccine production workshop.
Dozens of volunteers completed the vaccination, 2 doses per person
Surging News: What safety and effectiveness tests were carried out before the clinical trials? What are the test results?
Gong Xuejie: First, after separating and screening the strain CZ strain used in vaccine production, establish a tertiary virus stock for vaccine production. Second, determine the vaccine preparation process, establish key verification methods, and establish vaccine quality standards. Then, the vaccine was subjected to single-dose toxicity test, allergenicity test, repeated-dose toxicity test and other safety evaluations, and the results showed that the vaccine was safe in animals. Subsequently, the vaccines were studied with different doses, different immunization procedures, immunogenicity, and challenge protection. The results showed that the vaccines can produce a good immune response in animals, and the vaccines have obvious protective effects on animals after immunization. To antibody-dependent enhancement (ADE). Finally, the recovered serum from different sources can produce cross-neutralization reactions to different new coronavirus strains at home and abroad, and the vaccine also has good cross-neutralization reactions to different new coronavirus strains at home and abroad. The use of vaccines worldwide provides data support.
Surging News: In this phase I clinical trial, how many volunteers have been vaccinated? How many injections are needed? What criteria are used to determine the dose of volunteers?
Gong Xuejie: Up to now, dozens of volunteers have completed vaccination in clinical trials. Each volunteer received 2 doses of vaccine or placebo control.
In the preclinical research stage, the researchers inoculated mice, rats and other animals with different doses of the inactivated new coronavirus vaccine according to different immunization procedures, and then collected blood from the test animals at different time points to determine their serum levels after immunization. The neutralizing antibody titer and IgG antibody titer are used to evaluate the immunogenicity of the new inactivated coronavirus vaccine, and the formulation, dosage and immunization procedure of the vaccine are estimated based on the results of the immunogenicity.
Surging News: What kind of screening did the volunteers recruited this time conduct? Volunteers are healthy volunteers between the ages of 18 and 59. How is this age range determined?
Gong Xuejie: According to the clinical research program, our screening of volunteers includes new coronavirus IgG, IgM, and nucleic acid screening. All three results must be negative. In addition, there are blood routine, urine routine, blood biochemistry, past history, current medical history and other tests, and the results can be vaccinated only if they are the same.
The target population of the new inactivated coronavirus vaccine developed this time is the whole population, but researchers will first conduct clinical trials of healthy volunteers between the ages of 18 and 59 according to the practice. After obtaining safety data, we will continue to carry out the elderly Group and children's clinical trials.
Surging News: After the first batch of volunteers were vaccinated, what kind of medical observation did they receive?
Gong Xuejie: According to the clinical research protocol, all personnel will observe the safety at the test site for 30 minutes after vaccination. During the inoculation period, the researchers will conduct safety visits to all vaccinated persons on days 1, 2, 3, 4, 7, and 30 after vaccination; meanwhile, blood routine, blood biochemical and Urine routine examination to evaluate the effect of vaccination on the liver and kidney functions of the subject.
Preliminary results show that the vaccine is safe
Surging News: After the vaccination, did the volunteers have abnormal reactions such as fever, fatigue, and muscle pain? If so, is this within the researchers' expectations?
Gong Xuejie: According to the information provided by the vaccine researchers, the safety visit on the first day after vaccination has been completed. The preliminary results show that the vaccine is safe and the specific data will be released by the researchers in due course.
Surging News: How to choose a city for clinical trials? Why choose Xuzhou, Jiangsu?
Gong Xuejie: The Jiangsu Provincial Center for Disease Control and Prevention has extensive experience in clinical research and evaluation. The third phase of the Kexing EV71 vaccine (EV71 type hand-foot-mouth disease vaccine) was completed by them. We choose the investigator, and the investigator chooses the appropriate clinical research site.
Surging News: When are Phase II and Phase III clinical trials expected?
Gong Xuejie: After obtaining the safety data related to the Phase I clinical trial, the investigator and the ethics committee approved the start of the Phase II clinical trial. At present, the sponsors and researchers of this project have reached a consensus and obtained the approval of the ethics committee, which will accelerate the implementation of phase II clinical research.
Surging News: Phase I is an observation test for safety. What are the purposes of Phase II and III?
Gong Xuejie: The State Food and Drug Administration has approved Phase I and Phase II clinical trials of the new inactivated vaccine. At this stage, our research focuses on evaluating the safety of the vaccine based on changes in the health indicators of volunteers after vaccination. There are only a small number of samples in Phase I clinical trials, and the number of samples will be expanded in Phase II, which can give indicators of safety and effectiveness. In this process, we are also designing vaccine applicable studies for a larger group of people, including possible phase III clinical studies.
The main design of the Phase III clinical study is to see the changes in the incidence rate in the vaccine group and the control group to evaluate the effectiveness of the vaccine, so this is the main content and task of clinical research in the future stage.
However, the current challenge is that China's epidemic situation has been basically controlled, and the global epidemic situation is constantly expanding. In this case, how to carry out the next phase of clinical research. We are actively communicating with relevant departments to closely monitor the global epidemic situation Follow up to determine the next clinical plan.
Surging News: How to determine the dosage of Phase II and Phase III injections?
Gong Xuejie: The doses designed for Phase I and Phase II clinical studies are the same. When Phase III (if available), the determined dose for the corresponding age group will be determined based on the results of the previous studies.
Surging News: How is the Phase III clinical trial conducted?
Gong Xuejie: In the phase Ⅰ and Ⅱ clinical studies, we will select areas with low incidence of new crown epidemics to avoid the influence of interference factors, thus verifying the safety and immunogenicity of the vaccine. The phase III clinical trials and related vaccine application research will be designed according to the epidemic area, epidemic time and key population of the new crown epidemic, and will be implemented after obtaining approval from the drug approval department.
There is no timetable for when clinical trials will be completed
Surging News: All three phases of clinical trials have been completed. When is it estimated?
Gong Xuejie: The application of vaccines is measured in terms of the risk of epidemic prevention and control, the risks and costs of vaccine application, and we will continue to provide safety and effectiveness data of vaccine research to relevant departments for reference. At present, we do not have a clear timetable. But we will speed up the research. Inactivated vaccine technology is safe and reliable, and the safety of the vaccine is also high. It can be put into use as soon as possible after the effectiveness is evaluated.
Surging News: If the clinical trials of vaccines are going well, when will mass production be popularized?
Gong Xuejie: Considering the urgency of epidemic prevention and control, Kexing Zhongwei has started the construction of a new production plant for the new crown vaccine.
Although the State Drug Administration approved the clinical study of the vaccine, our entire vaccine production and quality control research is still ongoing. We hope that after the safety and effectiveness evaluation of the vaccine is completed, we can provide the country with more production quality data. To provide a basis for relevant departments to judge the use of vaccines.
Surging News reporter Xue Shasha