This article comes from the WeChat public account: Big Data Digest (ID: BigDataDigest) , the picture from: Visual China
At 21:00 on May 22th, Beijing time, the international academic journal “The Lancet” (The Lancet) published the world ’s first reorganization online The results of Phase I clinical trials of adenovirus type 5 vector new crown vaccine, and said in a press release: “Clinical data shows that the vaccine is safe and can induce a rapid immune response.”
It is even more worth mentioning that this research result comes from the team of Chinese researchers Chen Wei, academician of the Chinese Academy of Engineering.
Paper link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31208-3/fulltext
The paper shows that the aforementioned new crown vaccine using adenovirus Ad5 as a carrier shows immunogenicity and human tolerance 28 days after vaccination of volunteers. In healthy adults, the humoral immune response to SARS-CoV-2, on the 28th day after vaccinationReached the peak; Rapid specific T cell response, recorded from the 14th day after vaccination.
This result quickly caused a sensation in the industry. Richard Houghton, editor-in-chief of The Lancet, praised on Twitter: The first human experiment found that it has good safety and tolerance, and can induce a rapid immune response. “These results represent an important milestone.”
On Weibo, netizens also sent their blessings for the first time, commenting that “I look forward to the vaccine being developed as soon as possible.”
At the same time, some netizens said that they still need to be cautiously optimistic.
108 volunteers, started vaccinating 2 months ago
In fact, as early as March 16, the recombinant new crown vaccine developed by the academician Chen Wei team passed the clinical research registration review. At 20:18 that day, it was approved to enter the clinical trial.
A few days ago, screenshots from WeChat pre-announced the preliminary success of the study.
At noon on May 22, the international academic journal “The Lancet” (The Lancet) once told the surging news in the interview, The journal has confirmed the acceptance of the research paper on the clinical trial results of the new crown vaccine by the academician of the Chinese Academy of Engineering and the Institute of Biological Engineering, Institute of Military Medical Sciences, Academy of Military Sciences “> (Review) channel”, which is currently being further processed. After processing, it will be published online (online) .
The paper shows that from March 16 to March 27, 2020, the team of Academician Chen Wei screened 195 people for the experiment. Among them, 108 participants (51% male, 49% female; average age 36.3 years) , received low doses (n = 36) , medium-dose (n = 36) or high-dose (n = 36) vaccine. All registered participants are included in the analysis.
108 volunteers in Phase I clinical trials and 508 volunteers in Phase II clinical trials.
The first batch of 108 volunteers have been vaccinated successively since March 16. Subsequently, they were arranged to stay in the Wuhan Special Service Rehabilitation Center for centralized isolation and observation.
From March 31st, the first batch of volunteers ended their concentrated isolation observation and returned home. These volunteers collected blood samples on the 28th, 3rd, and 6th months after vaccination.
The results of the study showed that ELISA antibodies and neutralizing antibodies increased significantly on day 14 and peaked 28 days after vaccination. The specific T cell response peaked on the 14th day after inoculation.
Participants did not find serious adverse events within 28 days after vaccination. There were 30 (83%) participants, There were 30 (83%) participants in the medium-dose group, and 27 (75%) participants reported at least one adverse reaction dose group within the first 7 days after vaccination.
The most common adverse reaction at the injection site is pain. In 58 people (54%) Vaccine recipients have reported that the most common systemic adverse reaction is fever (50 [ 46%]) , fatigue (47 [44%]) , headache (42 [39%]) and muscle pain (18 [17%]) . Reported in all dose groups Most of the adverse reactions are mild or moderate.
The physical baseline characteristics of the participants are shown in the following table:
Chen Wei: The vaccine has the potential to be further researched and developed, but the results should be interpreted carefully
The repetition and mutation of the new coronavirus has left the world in panic, and the development of a safe and effective vaccine is seen as the fundamental way to overcome this global public health crisis.
This time, the world ’s first human clinical data of the new crown vaccine was released in The LancetPeople in the “dose of heart”.
In an interview with Surging News, Chen Wei said that these test results are an important milestone. The test results show that the single-dose Ad5-nCoV new crown vaccine can produce virus-specific antibodies and T cells within 14 days, which makes the vaccine has the potential for further research and development.
But Chen Wei also said that the results of these tests should be interpreted carefully. The challenge of developing a new crown vaccine is unprecedented. 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 the new crown virus.
Academician Chen Wei is a researcher at the Academy of Military Medicine. He was born in Lanxi, Zhejiang in 1966 (in Jinhua) , graduated from Zhejiang University in 1988 ， Graduated from Tsinghua University in 1991 and enrolled in the army in April of the same year; Graduated from the Academy of Military Medical Sciences in 1998 and promoted to Major General in 2015. He was elected as an academician of the Chinese Academy of Engineering in 2019. Director, researcher, doctoral tutor.
Speaking of vaccine research and development, Chen Wei said: “The successful entry of vaccines with independent intellectual property rights into clinical trials is a manifestation of China’s scientific and technological progress, as well as the image of a big country and the responsibility of a big country, and it is also a contribution to humanity.”
Reference material:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736 (20) 31208-3 / fulltext
https://mp.weixin.qq.com/s/E3f0gdej3P5HtPeerC7UhQ
https://baijiahao.baidu.com/s?id=1667400501689325237&wfr=spider&for=pc
https://news.windin.com/ns/findsnap.php?sourcetype=1&id=497442759&code=7377D7029C37&device=android&terminaltype=wwt.m&version=7.7.9
This article comes from the WeChat public account: Big Data Digest (ID: BigDataDigest) , the picture from: Visual China