Reporters : Li Chenyang, Ni Sijie
Publisher : Chinese Science News
Ref : http://news.sciencenet.cn/htmlnews/2020/5/440267.shtm
Translation, editing : Gan Yung Chyan
/ KUCINTA SETIA
In the evening of 22 May 2020, The Lancet published the results of the world's first human clinical trial of the covid vaccine, showing that the recombinant adenovirus type 5 vector covid vaccine is safe during the Phase I clinical period and can produce immunity against SARS-CoV-2 in the human body. Answer. The results of the experiment came from the team of Academician Chen Wei of the Institute of Biological Engineering, Academy of Military Medical Sciences, and Professor Zhu Fengcai, Jiangsu Provincial Center for Disease Prevention and Control.
The test results showed that within 28 days after the vaccination of the recombinant adenovirus type 5 vector covid vaccine, 108 volunteers had no serious adverse events. ELISA antibodies and neutralizing antibodies increased significantly on the fourteenth day and peaked 28 days after vaccination. The specific T cell response peaked on the fourteenth day after inoculation.
Chen Wei said that these results are an important milestone and prove that the recombinant adenovirus type 5 vector covid vaccine is a potential candidate vaccine.
But she also stressed that the above results should be interpreted with caution. "The challenge of developing a covid vaccine is unprecedented. The vaccine can trigger the above immune response, which does not necessarily mean that it can protect humans from the new crown infection. This result shows that the prospect of developing a covid vaccine is promising, but we have a long way to go from this vaccine."
The results of the study published this time only evaluated the subject’s condition for 28 days, and the final test results will be based on an assessment of the subject’s condition for 6 months.
The trial used 108 new-generation recombinant adenovirus type 5 vector covid vaccines at different doses for 108 healthy adults who were not infected with the virus, and evaluated the safety and effectiveness of the vaccine's immune response.
The subjects were divided into three groups on average, and were intramuscularly injected with low dose (5 × 1010 virus particles / 0.5 ml), medium dose (1 × 1011 virus particles / 1.0 ml) or high dose (1.5 × 1011 virus particles / 1.5 ml) ) Recombinant adenovirus type 5 vector new crown vaccine. After that, the researchers regularly tested the blood of volunteers to determine whether the vaccine stimulated the production of antibodies and T cell responses against SARS-CoV-2 (covi).
The study found that the most common adverse reactions at the injection site were pain, and the most common systemic adverse reactions were fever, fatigue, headache and muscle pain. A subject who received a high-dose vaccine reported severe fever, and severe symptoms such as fatigue, shortness of breath, and muscle pain, but these adverse reactions lasted less than 48 hours.
Within two weeks after vaccination, all dose levels of the vaccine triggered some degree of immune response, and some subjects detected neutralizing antibodies against covi. After 28 days, most of the subjects had a 4-fold increase in binding antibodies. Half of the subjects in the low-dose group and three-quarters in the high-dose group showed neutralizing antibodies against covi.
Currently, there are more than 100 candidate covid vaccines under development all over the world. A randomized, double-blind, placebo-controlled recombinant adenovirus type 5 vector covid vaccine has been launched in Wuhan in Phase II to determine whether the results can be repeated and whether there will be any adverse events within 6 months after vaccination. For the first time, the Phase II clinical trial included subjects over 60 years of age.
Paper related information:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/fulltext
Publisher : Chinese Science News
Ref : http://news.sciencenet.cn/htmlnews/2020/5/440267.shtm
Translation, editing : Gan Yung Chyan
/ KUCINTA SETIA
In the evening of 22 May 2020, The Lancet published the results of the world's first human clinical trial of the covid vaccine, showing that the recombinant adenovirus type 5 vector covid vaccine is safe during the Phase I clinical period and can produce immunity against SARS-CoV-2 in the human body. Answer. The results of the experiment came from the team of Academician Chen Wei of the Institute of Biological Engineering, Academy of Military Medical Sciences, and Professor Zhu Fengcai, Jiangsu Provincial Center for Disease Prevention and Control.
The test results showed that within 28 days after the vaccination of the recombinant adenovirus type 5 vector covid vaccine, 108 volunteers had no serious adverse events. ELISA antibodies and neutralizing antibodies increased significantly on the fourteenth day and peaked 28 days after vaccination. The specific T cell response peaked on the fourteenth day after inoculation.
Chen Wei said that these results are an important milestone and prove that the recombinant adenovirus type 5 vector covid vaccine is a potential candidate vaccine.
But she also stressed that the above results should be interpreted with caution. "The challenge of developing a covid vaccine is unprecedented. The vaccine can trigger the above immune response, which does not necessarily mean that it can protect humans from the new crown infection. This result shows that the prospect of developing a covid vaccine is promising, but we have a long way to go from this vaccine."
The results of the study published this time only evaluated the subject’s condition for 28 days, and the final test results will be based on an assessment of the subject’s condition for 6 months.
The trial used 108 new-generation recombinant adenovirus type 5 vector covid vaccines at different doses for 108 healthy adults who were not infected with the virus, and evaluated the safety and effectiveness of the vaccine's immune response.
The subjects were divided into three groups on average, and were intramuscularly injected with low dose (5 × 1010 virus particles / 0.5 ml), medium dose (1 × 1011 virus particles / 1.0 ml) or high dose (1.5 × 1011 virus particles / 1.5 ml) ) Recombinant adenovirus type 5 vector new crown vaccine. After that, the researchers regularly tested the blood of volunteers to determine whether the vaccine stimulated the production of antibodies and T cell responses against SARS-CoV-2 (covi).
The study found that the most common adverse reactions at the injection site were pain, and the most common systemic adverse reactions were fever, fatigue, headache and muscle pain. A subject who received a high-dose vaccine reported severe fever, and severe symptoms such as fatigue, shortness of breath, and muscle pain, but these adverse reactions lasted less than 48 hours.
Within two weeks after vaccination, all dose levels of the vaccine triggered some degree of immune response, and some subjects detected neutralizing antibodies against covi. After 28 days, most of the subjects had a 4-fold increase in binding antibodies. Half of the subjects in the low-dose group and three-quarters in the high-dose group showed neutralizing antibodies against covi.
Currently, there are more than 100 candidate covid vaccines under development all over the world. A randomized, double-blind, placebo-controlled recombinant adenovirus type 5 vector covid vaccine has been launched in Wuhan in Phase II to determine whether the results can be repeated and whether there will be any adverse events within 6 months after vaccination. For the first time, the Phase II clinical trial included subjects over 60 years of age.
Paper related information:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/fulltext
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