19 February 2021

Experiments on volunteers

Britons will infect healthy volunteers with coronavirus

Oleg Lischuk, N+1

For the first time in the world, the British Council for the Ethics of Clinical Trials has approved the experimental infection of healthy volunteers with the SARS-CoV-2 coronavirus strain that causes covid. The corresponding study should begin within a month, it says on the website of the government of the country.

The history of deliberate infection of people with an infectious agent for scientific purposes dates back to the XVIII century, when the English physician Edward Jenner empirically discovered the principle of vaccination. He vaccinated about 6,000 people with cowpox, which protected them from the much more dangerous smallpox. In the first half of the XX century, experiments on human infection began to be conducted at the state level, and the test subjects (usually prisoners or representatives of socially unprotected segments of the population) often did not know about it. Such practices were outlawed with the adoption of the Nuremberg Code in 1947, which for the first time spelled out such fundamental principles as informed consent, voluntary participation and the right to leave the study.

In the last 40-50 years, infection of healthy volunteers has become increasingly widespread, helping to study influenza, malaria, tuberculosis, dengue fever and many other infections, as well as their potential vaccination. With regard to vaccinations, it is especially valuable because it allows you to quickly and inexpensively obtain a preliminary assessment of the effectiveness of the drug on several dozen volunteers, while full-fledged clinical trials take years with the participation of hundreds and thousands of people. Nevertheless, studies of this type involve the risk of permanent harm to the health of the participant and the spread of infection, although it is minimized.

The upcoming British study is designed to involve up to 90 carefully selected healthy volunteers aged 18 to 30 years. To minimize the risk, a strain of the virus circulating in the country since March 2020 will be used. It will be prepared by the Great Ormond Street Children's Hospital in collaboration with hVIVO, a company specializing in such research, with the participation of Imperial College London.

The participants will be in specially equipped infectious isolation wards under round-the-clock medical supervision. To start testing, the Royal Free Hospital and the Adult Emergency Care Network in North and Central London need to be sanctioned, which are responsible for ensuring that such scientific work will not interfere with providing care to patients in a pandemic.

As a member of the research group, immunologist Christopher Chiu from Imperial College London, told Science magazine, soon after infection, volunteers will be offered remdesivir, an antiviral drug with variable efficacy against covid, approved in a number of countries to help with severe infection. To assess the effectiveness of treatment, participants will have their viral load checked twice a day.

The objectives of the study include determining the minimum dose of the virus required for infection; studying the immune response, pathways of isolation and transmission of the pathogen; evaluating the effectiveness of existing and candidate vaccines against covid.

"Although significant progress has been made in the development of vaccines, we want to determine the best and most effective drug for long–term use," said Kwasi Kwarteng, Minister of Entrepreneurship, Energy and Industrial Strategy of the United Kingdom. The Government of the country allocated 33.6 million pounds (about 46.8 million dollars at the current exchange rate) to conduct the study.

The British initiative has had many critics. Their main arguments are that even a mild course of covid can have long-term consequences, and conventional clinical trials can provide answers to these questions. Nevertheless, many Britons have already expressed their willingness to participate in the study. A special website has been created to receive their applications.

As of February 2021, 66 candidate vaccines against coronavirus are undergoing clinical trials worldwide. Ten similar drugs have been approved for use in at least one country, of which four are based on a viral vector, two are based on RNA, three are based on an inactivated virus and one is a peptide.

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