The world's first clinical trial results of the reorganized coronary vaccine I have been announced, and the results of the results are satisfactory. This research results come from Chinese scientists.
According to surging news reports, The Lancet issued a press release yesterday (22nd) that the open label and 108 healthy adult volunteers participated.Evaluate within six months; further tests are needed to evaluate whether the vaccine can effectively prevent crown disease infection.
The research results come from Chen Wei, an academician of the Chinese Academy of Engineering and a researcher at the Academy of Military Medical Sciences at the Academy of Military Sciences. The team developed the aforementioned AD5 crown vaccine and took the lead in conducting phase I and phase II clinical trials.
At 9 o'clock in the evening of last night, Liu Ye Dao published the research papers of Chen Wei's team on the results of the clinical trial of Phase I of Vaccine.The Chen Wei team screened 108 volunteers from 195 people from March 16 to March 27 to conduct phase I clinical trials.This is the first time this type of coronary vaccine has been tested in the human body.
51%of the subjects are men, 49%are women, with an average age of 36.3 years.There are 36 people in low -dose groups, medium dose groups, and high dose groups.The paper states that within seven days after vaccination, 30 people in low -dose groups, 30 people in the medium dosage group, and 27 people in high doses were at least one adverse reaction.
These adverse reactions include: mild pain, fever, fatigue, headache, and muscle pain occur on the injection site.The test results show that the vaccine has good tolerance under all doses, and has not reported serious adverse events within 28 days after vaccination.Most adverse events are mild or moderate.
Within 14 days after the vaccination, the subjects of each dose group triggered a certain level of immune response, producing binding antibodies.After 28 days of vaccination, most of the subjects in the body appeared neutralized antibodies in the body.Among them, the proportion of antibodies in the low dose group is 78 %, the medium dose group is 92 %, and the high dose group is 100 %.
In the information provided by Liu Ye Dao, Chen Wei said that these clinical trial results were an important milestone.It shows that the vaccine can cause the human body to produce specific antibodies and T cells within 14 days, which gives the vaccine's potential for further research and development.
However, Chen Wei also said that these test results should be explained carefully. Even if the vaccine has the ability to trigger the aforementioned immune response, it does not necessarily mean that this vaccine can help people resist crown disease., But there is still a long way to go before the vaccine listing.
The researchers noticed that only 108 volunteers participated in the aforementioned clinical trials, and the test time was short, and there was a lack of random control. Therefore, there was a certain limitations in discovering adverse reactions and the protection of vaccines.At present, a phase II clinical trial with 500 volunteers, random, double -blindness, and control is in Wuhan to observe whether the results of the aforementioned clinical trials can be copied, and whether it will appear within six months after vaccination.Adverse reactions.
