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Clinical human trials begin for COVID-19 vaccine in China

JSCh

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Clinical human trials begin for COVID-19 vaccine in China - Global Times
Source:Global Times Published: 2020/3/21 16:09:05

A multi-center clinical trial for China's self-developed AIDS vaccine started this year and is currently in progress. Photo: VCG

Chinese volunteers in a clinical trial for the first COVID-19 vaccine, developed by the country's military scientists, received their injections on Friday, media reported on Saturday.

The product is a recombined vaccine developed by a team headed by Chen Wei, an expert at expert at biological hazard prevention and control from the PLA Academy of Military Medical Sciences and major general of the Chinese military. The team undertook pharmaceutical and toxicological research for a COVID-19 vaccine in cooperation with local companies, based on their previous successful experience in developing an Ebola vaccine.

Unlike other clinical trials, in the trial conducted by Chen's team, volunteers do not need to be infected with the novel coronavirus after receiving the vaccination. Rather, the researchers will test if anti-bodies have been created and if the volunteers have become immune to the virus.

The first batch of volunteers, all Wuhan permanent residents aged between 18 and 60, has been divided into three groups, each consisting of 36 members.

They will be quarantined for 14 days and researchers will follow them for six months to monitor any adverse reactions.

The vaccine developed by Chen's team passed a clinical research registration review and was approved for clinical trial on Monday night, about 19 hours after the US announced it would start human trials for the first coronavirus vaccine, revealing the two largest economies are level in the race to resolve the public health crisis.

US researchers administered the first injections in the country's first trial of an experimental coronavirus vaccine on Monday.
 

JSCh

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China's coronavirus vaccine begins human trials - cnTechPost
March 21, 2020


A new coronavirus vaccine developed in China has been injected into humans. There are 3 groups of volunteers with each group having 36 people. They will be observed in isolation for 14 days after injection, according to the
Science and Technology Daily.

Organizers of the trial are the Institute of Bioengineering of the Academy of Medical Sciences of the Academy of Military Sciences and Cansino Biotech.

The purpose of the test is to test and evaluate the safety and effectiveness of the new recombinant coronavirus vaccine (adenovirus vector).

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.

Chen Wei, the project leader, a member of the Chinese Academy of Engineering and a researcher at the Military Medical Research Institute, explained its principle in this way: on the premise of "learning" the virus, "surgery" the virus, using flowers and trees to transform a carrier we need The virus is injected into the body to produce immunity.

There are not many volunteers required for Phase I trials. They are limited to residents of Wuhan, and residents of Wuchang, Hongshan, and Donghu Scenic Areas are preferred.

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.

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.


 

Yaseen1

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does this vaccine is also for treatment of those who have caught this disease and are suffering from severe illness or this is only for prevention of catching disease like polio vaccine
 

PakSword

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does this vaccine is also for treatment of those who have caught this disease and are suffering from severe illness or this is only for prevention of catching disease like polio vaccine
Vaccine only works on people who haven't contracted the disease yet.
 

Yaseen1

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scientists should also work on medicine for those who are suffering from such diseases like they did for hepatitis c, Aids and many other viral diseases which increased life expectancy of such patients
Vaccine only works on people who haven't contracted the disease yet.
 

JSCh

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China injects volunteers with test vaccine, showing strong research capability
By Leng Shumei and Hu Yuwei Source:Global Times Published: 2020/3/21 16:09:05 Last Updated: 2020/3/21 17:07:34

Photo: VCG

Chinese volunteers in a clinical trial for the first COVID-19 vaccine developed by the country's military scientists received injections on Friday, marking a significant breakthrough that highlights China's strong research capabilities, according to experts.

The first batch of volunteers, all Wuhan permanent residents aged between 18 and 60, has been divided into three groups, each consisting of 36 members, the Science and Technology Daily reported on Saturday.

They will be quarantined for 14 days and researchers will follow them for six months to monitor any adverse reactions.

The product is a recombined vaccine jointly developed by Tianjin-based biotechnology company CanSino Biologics Inc and a research team headed by Chen Wei, an expert of biological hazard prevention and control from the PLA Academy of Military Medical Sciences and a major general of the Chinese military.

Since arriving in Wuhan in late January, Chen's team has undertaken pharmaceutical and toxicological research for a COVID-19 vaccine in cooperation with local companies, based on the military team's previous successful experience in developing an Ebola vaccine.

Unlike other clinical trials, in the trial conducted by Chen's team, volunteers do not need to be infected with the novel coronavirus after receiving the vaccination. Rather, the researchers will test if anti-bodies have been created and if the volunteers have become immune to the virus.

The product passed a clinical research registration review and was approved for clinical trial on Monday night, about 19 hours after the US announced it would start human trials for the first coronavirus vaccine, revealing the two largest economies are level in the race to resolve the public health crisis.

US researchers administered the first injections in the country's first trial of an experimental coronavirus vaccine on Monday. The US' vaccine candidate, code-named mRNA-1273, was developed by the National Institutes of Health and the Massachusetts-based biotechnology company Moderna Inc.

The development of the recombinant vaccine involved inserting the novel coronavirus' DNA encoding antigen into other microorganisms to create a new virus, which will not infect receivers with the disease, according to a Beijing-based immunology expert who asked to remain anonymous.

The difference between a recombinant vaccine and an RNA vaccine is that the former is protein-based and the latter is an RNA sequence.

A recombinant vaccine requires a longer research period than an RNA vaccine, but the fact that China is beginning human trials shortly after the US demonstrates its strong vaccine research and development capabilities, the expert told the Global Times on Saturday.

He called the move a remarkable step in the global competition of coronavirus vaccine development, showing China's latest breakthrough in vaccine R&D.

Following clinical trials, experts estimate it will take at least one year to complete further procedures before the vaccine officially enters the market. But some products may be available for emergency usage by the end of this year due to Chinese authorities' nod to a green channel for drugs and vaccines as well as the joint efforts of experts and researchers across the country, according to analysts.

China gave top priority to vaccine development as early as the beginning of the outbreak and has been accelerating the process according to law and on the premise of safety and effectiveness, Wang Junzhi, an academician at the Chinese Academy of Engineering, told a press conference in Beijing on Tuesday.

China's health authority previously announced that some of the vaccines developed in the country could be available in April for use in emergency situations, given that the country is developing five types of vaccines at the same time, including an inactivated vaccine, an attenuated influenza virus vaccine and a nucleic acid-based vaccine.

While some analysts worry it could be difficult to recruit volunteers for vaccine trials as the situation gradually eases in China, Chinese netizens have actively expressed their willingness to join the trials and contribute to research when it expands to places outside Wuhan.

Hai Feng (pseudonym), who was among the first group of volunteers to receive the trial vaccine on Friday, told media that he had no regrets and that he "would do what he could to help the country and society."

Li Ming (pseudonym), a resident in Wuhan and the husband of a recovered COVID-19 patient, signed up for the trial as soon as he heard of the call for volunteers.

"If people have to live with the novel coronavirus for a long time, a vaccine is the most important part of the efforts to fight against it," Li was quoted to have said by the Science and Technology Daily.
 

Beidou2020

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Vaccine will take a long time to be available and by that time COVID-19 will be forgotten.

There are treatments that are available right now used around the world that are proving very effective for COVID-19. Patients that are critical should be given the option to try to save their life. Western process is slow and too bureaucratic to respond rapidly to an emergency.

upload_2020-3-22_4-50-38.jpeg


upload_2020-3-22_4-51-42.jpeg
 
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Viet

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China's coronavirus vaccine begins human trials - cnTechPost
March 21, 2020


A new coronavirus vaccine developed in China has been injected into humans. There are 3 groups of volunteers with each group having 36 people. They will be observed in isolation for 14 days after injection, according to the
Science and Technology Daily.

Organizers of the trial are the Institute of Bioengineering of the Academy of Medical Sciences of the Academy of Military Sciences and Cansino Biotech.

The purpose of the test is to test and evaluate the safety and effectiveness of the new recombinant coronavirus vaccine (adenovirus vector).

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.

Chen Wei, the project leader, a member of the Chinese Academy of Engineering and a researcher at the Military Medical Research Institute, explained its principle in this way: on the premise of "learning" the virus, "surgery" the virus, using flowers and trees to transform a carrier we need The virus is injected into the body to produce immunity.

There are not many volunteers required for Phase I trials. They are limited to residents of Wuhan, and residents of Wuchang, Hongshan, and Donghu Scenic Areas are preferred.

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.

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.



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.”

seriously, does anyone understand it?
Can’t they explain in simple words?

:hitwall:
 

JSCh

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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.”

seriously, does anyone understand it?
Can’t they explain in simple words?

:hitwall:
It was translated from a report in Chinese, hence the awkward wording.

A better layman explanation would be from this report,
The development of the recombinant vaccine involved inserting the novel coronavirus' DNA encoding antigen into other microorganisms to create a new virus, which will not infect receivers with the disease, according to a Beijing-based immunology expert who asked to remain anonymous.
My understanding is it is like traditional vaccine, take a mild/harmless version of the virus, inject into receiver so their immune system would be trained to recognize the virus. The main difference would be instead of looking for mild/harmless version in nature, researcher actually create one by separating and inserting the virus's antigen (which would cause the immune system to produce antibodies) into another microorganism that do not have the capabilities of inserting its DNA into human cell, therefore cannot infect human.
 
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JSCh

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Weibo post of one of the volunteer.

萍萍_816
3月21日 22:48 来自 iPhone客户端 已编辑
3.21,疫苗注射后隔离的第五天。3月16日晚20时18分,我成为陈薇院士团队研制的重组新冠疫苗临床试验第一批受试者(当晚4人),开始为期14天的医学观察,到目前为止,一切都好,期待9天后的好消息,期待人类早日彻底打败新冠病毒!!! 2武汉 2武汉 2武汉
March 21 22:48 F
3.21, fifth day of quarantine after vaccine injection. At 20:18 on the evening of March 16, I became the first batch of subjects (4 people that night) for the recombinant nCoV vaccine clinical trial developed by Academician Chen Wei's team, and started a 14-day medical observation. So far, everything is fine. Looking forward to the good news in 9 days, we look forward to the early and complete defeat of the nCoV by humans! !!



 

JSCh

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Interview: China's COVID-19 vaccine trial results "very impressive," says U.S. epidemiologist
Source: Xinhua| 2020-05-28 04:42:19|Editor: huaxia

A staff member displays samples of the COVID-19 inactivated vaccine at Sinovac Biotech Ltd., in Beijing, capital of China, March 16, 2020. (Xinhua/Zhang Yuwei)

China's COVID-19 vaccine trial results are "very impressive," a leading U.S. epidemiologist said, echoing a recent study published by The Lancet.

by Xinhua writer Tan Jingjing

WASHINGTON, May 27 (Xinhua) -- The results of China's COVID-19 vaccine trial, the first such vaccine to reach phase 1 clinical trial, are "very impressive," a leading U.S. epidemiologist told Xinhua in a recent interview.

China's vaccine trial has been found to be safe, well-tolerated, and able to generate an immune response against SARS-COV-2 in humans, according to a study published online last Friday by medical journal The Lancet.

"The vaccine seemed to be well tolerated at the three doses tested, and vaccine recipients generated potent immune responses against the coronavirus as measured both in tests of neutralizing antibodies and T-cells," said Robert Schooley, a professor of medicine with the Division of Infectious Diseases and Global Public Health at the University of California, San Diego.

The Chinese research team conducted the open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. A total of 108 healthy adults aged between 18 and 60 were recruited and allocated to three different dose groups to receive the vaccine.

Robert Schooley, professor of medicine at the Division of Infectious Diseases and Global Public Health at the University of California, San Diego (UC San Diego), speaks in an interview with Xinhua in San Diego, the United States, Feb. 28, 2020. (Xinhua/Li Ying)

The trial demonstrates promising results after 28 days and the final results will be evaluated in six months, according to a statement of The Lancet.

"Everyone had a T-cell response and most had an over 4 fold increase in neutralizing antibodies by day 28," said Schooley, adding that the immunogenicity results from the study are very impressive.

There is evidence that those who have clear pre-existing immunity to the adenovirus type 5 vector used to deliver the coronavirus antigens made less vigorous neutralizing antibody responses than those with lower levels of pre-existing immunity to adenovirus, said Schooley.

"This has been seen with other vaccines that use this approach and is one of the reasons that they don't work in all people and one of the things that limits using them repetitively in the same person -- as in providing what we commonly call 'booster' shots," he noted.

Further research is needed to observe whether there are differences in the strength of the responses in older volunteers, and whether the fall-off in T-cell immunity seen at day 28 continues, said Schooley, also editor-in-chief of Clinical Infectious Disease, a peer-reviewed medical journal published by Oxford University Press.

A staff member adjusts equipments at a vaccine production plant of China National Pharmaceutical Group (Sinopharm) in Beijing, capital of China, April 10, 2020. (Xinhua/Zhang Yuwei)

A randomized, double-blinded, placebo-controlled phase 2 trial of the Ad5-nCoV vaccine has been initiated in Wuhan to determine whether the results can be replicated, and if there are any adverse events up to six months after vaccination, in 500 healthy adults -- 250 volunteers given a middle dose, 125 given a low dose, and 125 given a placebo as a control, according to The Lancet.

Schooley said one of the challenges is that adenovirus type 5-based vaccines generally cannot be given repetitively as immunity to the coronavirus falls off, because the immunity to adenovirus persists and it makes subsequent responses to the vaccine less and less potent.

"Next steps here will be to see whether there are differences in immunogenicity in older people and how long the immunity persists," he said.

Immunity to natural coronavirus infection also declines rather quickly, which is one of the contributors to recurring waves of infection in the human population.

"If the vaccine immunity wanes as rapidly, and it is necessary to re-vaccinate every couple of years, they will likely need to develop a non-adenovirus type 5 based vaccine for the repeated vaccine," Schooley said.

He also stressed the importance of global cooperation in COVID-19 vaccine development, adding that collaboration across companies, countries and research groups will be essential to get different vaccine approaches into patients.
 

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