Recently, China's recombinant new crown vaccine has been approved to enter clinical trials. A total of 108 volunteers were recruited for the study and will be isolated for 14 days after the injection.
On March 16th, the recombinant new crown vaccine developed by Chen Wei, a member of the Chinese Academy of Engineering and a researcher at the Military Medical Research Institute of the Academy of Military Sciences, was officially approved for clinical trials.
As a volunteer in the Phase I clinical trial of a recombinant novel coronavirus (2019-COV) vaccine (hereinafter referred to as "recombinant coronavirus vaccine"), Ren Chao received the vaccine on March 20.
According to public information on the China Clinical Trials Registry, the sponsors of the Phase I clinical trial of the recombinant novel coronavirus Vaccine are the Institute of Bioengineering of the Academy of Medicine of the Academy of Military Sciences and Kangsino Biological Co., Ltd.
The purpose of the study was to "evaluate the safety and tolerability of a recombinant coronavirus vaccine (adenovirus vector) in healthy adults aged 18 to 60 years. This vaccine was constructed using genetic engineering methods, using replication-defective human type 5 adenovirus as a vector, and expressing the new coronavirus S antigen.
There are not many volunteers required for the Phase I trial, Wuhan residents only. Household registration residents in Wuchang District, Hongshan District and Donghu Scenic Area are preferred. Volunteers are required to be healthy adults between the ages of 18 and 60 with no history of covid-19 pneumonia or infection. Volunteers will be divided into three groups of low-dose, medium-dose and high-dose groups, with 36 people in each group.
After screening and physical examination, eligible volunteers can be vaccinated. The next 14 days are the observation period for centralized isolation. Seven blood samples were collected within 7 days before vaccination, on the day of vaccination, and on the 7th day, 14th day, 28th day, 3rd month, and 6th months after vaccination, mainly for antibody detection.
Within six months after the vaccination, the medical team will periodically follow up with the volunteers several times to see if they have any adverse reactions and whether anti-S protein-specific antibodies are produced in the body.
Testing the vaccine's effectiveness is not about getting volunteers and the virus to fight each other, but testing whether an antibody has been produced in the body. With antibodies, the immune system is ready to protect the virus from the cells.
On the other hand, scientific research is in full swing. According to Academician Wang Junzhi, vaccines in five major technological directions in China are generally progressing smoothly, and most of the nine tasks identified in the first batch have completed animal research. Most R & D teams can complete preclinical research in April and gradually start clinical trials.
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