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Zheng Ji, Yang
Biance, Li Gen, reported from the concave temple qubit | public account QbitAI
This (probably) is the most radical new crown experiment.
The UK, which was controversial because it was the first to shout "herd immunity", now proposes a more radical and controversial new plan:
Recruit healthy volunteers who have never been infected with the new coronavirus and deliberately infected.
In the process, the virus doses are compared in batches and progressively, hoping to finally clarify what dose is reached, most healthy humans will be infected with the new crown. After that, the remaining healthy volunteers will be divided into a placebo group and a vaccine group, and the experiment will start at the same time at the previously determined dose.
The UK hopes to recruit 500 volunteers, preferably between the ages of 18 and 30, each of whom will be paid 4,000 pounds, equivalent to about 35,000 yuan.
What a bold idea and experiment!
Human challenge experiment
Simply put, it is to recruit young and healthy volunteers, and then directly expose them to the live virus of COVID-19.
△图源：Andrey Rudakov/Bloomberg/Getty
Andrew Catchpole, a virologist and chief scientific officer from Open Orphan, who led the study, said:
The initial experiment will require 30 to 50 volunteers, and voluntary recruitment is only open to healthy adults aged 18 to 30.
However, the precise design of the study has not yet been finalized.
What is known is that a small number of participants are likely to receive a very low dose of SARS-CoV-2 "challenging strain". The source of these "challenging strains" was cultivated under stringent conditions by viruses that are currently spreading.
If no or only a small number of participants are infected under low-dose conditions, the researchers will seek permission from the independent safety monitoring committee to allow participants to withstand higher doses.
In response, Catchpole said:
This process will be repeated until the researchers can determine the dose that will infect most exposed persons.
Once the appropriate dose is determined, a series of comparative experiments can be conducted to test the effects of several vaccines.
Although Catchpole said, the design of these experiments has not yet been determined, including which vaccines will be used.
He envisaged that some participants received placebo injections directly instead of vaccine injections, as a control group, and each experimental group usually requires 40-50 volunteers to be recruited.
However, as a deadly pathogen, SARS-CoV-2 has almost no proven treatment. It is still unknown whether experiments that intentionally infect people will be recognized in the fields of medicine and bioethics.
If regulatory and ethical approval is obtained, the experiment will begin in a London hospital in January next year to accelerate the development of a vaccine that may end the pandemic.
Ethical issues
Nir Eya, a bioethicist at Rutgers University, expressed concern about the ethics of the experiment. He worried that people would participate for money reasons without knowing the risks.
Nir Eya believes that the new crown challenge test needs to ensure that participants understand the risks in order to conduct it safely and ethically.
It can be done safely and ethically. But he said, for example, a well-designed online course can ensure that participants understand the risks.
Seema Shah, a bioethicist at Northwestern University, said it is also important to ensure that participants understand the limitations of the challenge trial.
She believes that due to the ongoing phase III trials of a large number of new crown vaccines, it is impossible for challenge trials to accelerate the development of the first batch of vaccines.
Meagan Deming, a vaccine scientist and virologist at the University of Maryland School of Medicine, believes that the challenge test is more suitable for studying the basic aspects of new coronavirus infection, such as the possibility of reinfection.
Deming said that because such trials may only involve healthy young people, they may not disclose too much information about how the vaccine protects those most at risk of serious diseases, such as the elderly and people with diseases such as diabetes.
The UK is not the only country studying the COVID-19 challenge. The Belgian government has pledged to invest 20 million euros in a challenge test, possibly involving the new crown. The Colorado State University laboratory is funding the development of two new crown challenge strains.
What do you think of this new test in the UK?
Reference link:
https://www.nature.com/articles/d41586-020-02821-4
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