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Original title: Was the first new human challenge test with coronavirus approved?
One year after the global outbreak of the new corona epidemic, the scientific community has made a lot of progress in the fight against the virus, but there are still many mysteries to be solved. The immune mechanism of the human body to the virus is not yet clear. For example, how much virus is required for the initial infection? How does the immune system improve initial defense capabilities? And who will have symptoms, etc.
On Wednesday, the UK became the first country in the world to pass the human provocation test for the new coronavirus. The trial was approved by the British Clinical Trials Ethics Committee. 90 healthy volunteers between the ages of 18 and 30 will be recruited. The clinical trial will be in a month.
The human challenge test to be carried out in the UK is primarily aimed at studying the mechanism of early infection of the virus in humans, including determining the minimum dose of virus required to cause infection and factors affecting spread. of the virus, as well as the analysis of the early immune response of the human body before symptoms appear.
The researchers will use the original, non-mutated version of the new coronavirus to target healthy volunteers and say that young people have the lowest risk of complications after contracting the new coronavirus. Additionally, volunteers will receive compensation of £ 4,500 in one year. This research was funded by the British government for £ 33.6 million.
Once preliminary research conclusions are drawn, subsequent clinical trials can provide participants with a new approved corona vaccine and then expose it to the virus to evaluate the most effective vaccine. However, late-stage clinical trials have not yet been approved.
The British government said in a statement: “Research on human provocation trials has been conducted safely for decades and has played a role in accelerating the development of treatments for diseases such as malaria, typhoid, cholera, norovirus and influenza. . Big role”.
According to the guidance and recommendations of the World Health Organization, subject to certain standards, human provocation tests are ethical. These standards include that protective measures must be clearly taken, including that the trial participants are relatively young and healthy, and that they provide the highest quality medical services and are monitored at any time; In addition, the possible personal and social risks and benefits must be considered. At the same time, pathogens that would not otherwise exist are released into the environment.
While provocation trials in humans play a key role in the development of treatment methods such as drugs and vaccines and can provide scientific data in a short period of time, the pathogenetic mechanism of the new coronavirus is still unclear until now. Therefore, such trials also exist. Dispute.
The main controversy is that, on the one hand, there is currently no confirmed cure for the new coronary disease; on the other hand, healthy young volunteers cannot represent the general population.
“This human challenge test is ethically controversial. I’m not sure if the data obtained from the study is really more significant than the potential risks it can bring.” A virologist who was involved in the development of the Ebola vaccine and the new vaccine crown said the first financial reporter.
He believes that the “unsolved mystery” about the new coronavirus that the human challenge test hopes to elicit can be verified by a combination of in vitro and in vivo tests, and can be tested in animals if necessary.
“The virus attack test that we usually do will use animals and give the animals a high dose of virus infection to test if the immunity is strong enough.” He told the CBN reporter: “The current human challenge test appears to be to test whether the smallest dose of virus can be caused. Infects, but those most in need of protection may not only be exposed to the environment with the least amount of virus. , so the importance of this test does not seem to be very great “.
The aforementioned experts also pointed out that if a serious incident occurs during the trial, which drugs to treat is a bigger problem. He Shudongzhuo: “If there is a death or disability in the treatment process, I am concerned that it may cause legal disputes.”
However, some experts believe that the risk of human challenge tests is controllable. “I think there are several indicators, such as what age group is participating in the trial, if there is a history of illness and allergies, and the challenge of hospitalization in the negative pressure ICU setting of the hospital infection department, then the risk general may be, “the person in charge of a national biomedical company told a China Business News reporter.
He also said that conducting scientific experiments to assess the minimum infectious dose will have instructive significance for future prevention and control measures for new corona diseases.
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