In May, 2020, The Lancet published the COVID-19 vaccine test results of Chen Wei's team. The Lancet is a scientist from China. According to the relevant public information, the team led by Chen Wei, an academician of China Academy of Engineering and a researcher at the Institute of Military Medicine of Academy of Military Sciences, developed the aforementioned Ad5 COVID-19 vaccine, and took the lead in conducting the first and second clinical trials. On/0/4 day after inoculation, the rapid specific T cell reaction reached its peak, and on the 28th day after inoculation, the humoral immune response producing neutralizing antibody reached its peak. At noon on the 22nd, The Lancet confirmed to the newspaper that the journal had accepted the research paper on the results of phase I clinical trial of COVID-19 vaccine led by Academician Chen Wei, and was taking the fast review channel. It was being further processed and published online after processing. At 2 1 on 22nd, the TheLancet, an international academic journal, published the above research paper online. The correspondent of this article is Academician Chen Wei, Professor Wang Wei, Dean of tongji hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, and Deputy Director Zhu of Jiangsu Provincial Center for Disease Control and Prevention. In COVID-19, an effective vaccine is regarded as a long-term solution to control the epidemic. At present, there are more than 65,438+000 candidate vaccines for COVID-19 being developed all over the world. From March 6th to March 27th, researchers led by Chen Wei selected 108 volunteers from 195 people for phase I clinical trial. This is the first time that this type of COVID-19 vaccine has been tested in humans. 5 1% subjects were male and 49% were female, with an average age of 36.3 years. There were 36 people in low dose group, middle dose group and high dose group. The low-dose group was injected with 0.5 ml of vaccine, which contained 5X 10X 10 modified virus particles, and the middle-dose group was injected with vaccine 1 ml. The high dose group was injected with 1.5 ml vaccine. Ad5 COVID-19 vaccine is a modified virus particle produced by using the replication-deficient Ad5 adenovirus of attenuated cold virus as the carrier. As a vaccine, it is still adenovirus particles, but due to the defects caused by gene deletion, it can not be replicated and can not be rampant. They are still easy to infect human cells, but they will not cause disease. Their genes also contain a COVID-19 gene-the ——spik gene. As a result, virus particles became launch vehicles, and spike genes became satellites to be launched. When volunteers were injected with COVID-19 vaccine, the modified adenovirus particles entered the human body, infected the cells, and delivered the spike gene to the cells. Then, the cells produce spike proteins, which reach the lymph nodes. Therefore, lymph nodes produce antibodies-antibodies that recognize spike proteins and fight COVID-19. According to the paper, 30 people in the low dose group, 30 people in the middle dose group, 83% people in the high dose group and 75% people in the high dose group had at least one adverse reaction within 7 days after vaccination. These adverse reactions include: more than half of 54%, 58/ 108 vaccinators have mild pain, fever (46%, 50/ 108 fatigue, 44%, 47/ 108 headache, 39%, 42//kloc-0. The results showed that the vaccine was well tolerated at all doses, and serious adverse events was not reported within 28 days after inoculation. Most adverse events were mild or moderate. The ideal vaccine can trigger two kinds of immune responses in human body: humoral immune response and T cell response. The researchers regularly test the components in the blood samples of the subjects to determine the strength of the immune response triggered by the vaccine. The aforementioned papers show that within 14 days after vaccination, the subjects in each dose group triggered a certain level of immune response and produced binding antibodies. The specific ratio is: low dose group 16/36, 44%. The middle dose was 18/36, 50%, and the high dose was 22/36, 6 1%. Some subjects produced detectable levels of neutralizing antibodies, and the vaccine also triggered T cell reactions in most volunteers. Twenty-eight days after inoculation, most subjects showed T cell reaction or detectable level of neutralizing antibody. The specific ratio was 28/36, and the low dose group was 78%. The researchers also found that if the subjects were inoculated with adenovirus Ad5 in advance, the immune effect of the vaccine might be weakened, such as the peak level of immune response decreased and the persistence of immune response shortened. As far as we know, this is the first human trial of COVID-19 vaccine with Ad5 adenovirus vector, and it is also the first research report of FIH. The newspaper wrote. In the information provided to the paper by The Lancet, Chen Wei said that these clinical trial results are an important milestone. These results indicated that a single dose of Ad5-nCoV COVID-19 vaccine could produce specific antibodies and T cells within 14 days. This makes the vaccine have the potential for further research and development. Chen Wei also said that these test results should be carefully interpreted. The challenge of developing COVID-19 vaccine is unprecedented. Even if the vaccine has the ability to trigger the above immune response, it does not necessarily mean that the vaccine can help people resist COVID-19 virus. The above clinical trial results show that the prospect is promising, but we still have a long way to go before the vaccine goes on the market. The researchers also noticed that only 108 volunteers participated in the aforementioned clinical trial, and the trial time was short and there was no randomized control. Therefore, there are some limitations in finding adverse events or finding the protective power of vaccines. At present, Wuhan is conducting a randomized, double-blind, controlled phase II clinical trial involving 500 volunteers, to observe whether the results of the aforementioned phase I clinical trial can be replicated and whether there will be adverse events within 6 months after vaccination. People over 60 also participated as subjects for the first time. According to the previous report in the paper, on March 16, the recombinant COVID-19 vaccine developed by Academician Chen Wei passed the clinical research registration review, and was officially allowed to enter the clinical trial at 20: 00 on the same day. There are 108 volunteers in the first phase clinical trial and 508 volunteers in the second phase clinical trial. The first batch of 108 volunteers started vaccination on106 in March. Subsequently, they were arranged to live in Wuhan Special Service Rehabilitation Center for centralized isolation and observation. From March 3 1 day, the first batch of volunteers ended their centralized isolation observation and returned to China. These volunteers collected blood samples on the 28th day, 3rd month and 6th month after vaccination. According to the client news of Beijing Daily, the second phase clinical trial of the vaccine was started on April 12, and it was the only COVID-19 vaccine that entered the second phase clinical trial in the world at that time. On April 25th, Academician Chen Wei introduced on the theme live broadcast of the National Children's Vaccination Day that because China shared the gene virus sequence separated by scientists with WHO, she led the team to start vaccine research at the first time. On March 16, the first phase of adenovirus vector COVID-19 vaccine was officially approved, and the first volunteer was injected that day. After that, the vaccine development progressed smoothly, and the statistical data of 7 days and 14 days safety were obtained. On this basis, the vaccine entered the second phase of clinical trials.