The UK will expose volunteers to Covid in the world’s first human challenge study

LONDON – The UK will be the first country in the world to conduct a study on the “human challenge” Covid-19, following the body’s approval of the country’s clinical trials ethics body.

The first Covid-19 human challenge trial will see up to 90 volunteers, aged 18 to 30, exposed to Covid-19 “in a safe and controlled environment to increase understanding of how the virus affects people.” said the British government in a statement. Wednesday.

Researchers are asking healthy young people, who are at the lowest risk for coronavirus complications, to volunteer for the study. Volunteers will be compensated for the time they spend in the study, which will begin within a month.

The study is backed by a £ 33.6 million ($ 46.6 million) investment from the British government, and the trial has been conducted through a partnership between the government’s Vaccines Taskforce, Imperial College London , the Royal Free London NHS Foundation Trust and the clinical company hVIVO, which has pioneered viral human challenge models.

The study will involve establishing the minimum amount of viruses needed to cause infection (known as a virus characterization study) with exposed volunteers “in a safe and controlled environment,” the government said.

“Volunteer safety is paramount, which means that this virus characterization study will initially use the version of the virus that has been circulating in the UK since March 2020 and has been shown to be at low risk in healthy young adults.” , added. Doctors and scientists will closely monitor the effect of the virus on volunteers and will be available to care for them 24 hours a day.

The study will help doctors understand how the immune system reacts to the coronavirus and identify factors that influence how the virus is transmitted, including how a person infected with Covid-19 transmits infectious virus particles to the environment. .

Once the initial study was conducted, participants could receive an approved vaccine and expose them to the Covid-19 virus to identify the most effective vaccines.

These trials are not without controversy, as participants are deliberately exposed to pathogens, but are considered to play a key role in the development of effective vaccines and treatments.

“For many decades, studies of human challenges have been conducted safely and have played an important role in accelerating the development of treatments for diseases such as malaria, typhoid, cholera, norovirus, and influenza.” pointed out the British government.

World Health Organization guidelines say that human challenge trials are ethical when they meet certain criteria. It is clear that protections should be in place, experts said, which include that trial participants are relatively young and in good health and are offered the highest quality medical care with frequent follow-up.

The WHO notes that it is essential that challenge trials be conducted “within an ethical framework in which truly informed consent is given” and that they be conducted with “abundant premise, caution and supervision.” .

We need to consider both the potential individual risks and benefits, according to the WHO, and the potential social benefits and risks, such as the release into the environment of a pathogen that might not otherwise be present.

The UK Human Challenge Trial will take place in the coming weeks at the Royal Free Hospital’s specialist and safe clinical research facility in London. These facilities “are specifically designed to contain the virus. Highly trained physicians and scientists will be available to closely examine the behavior of the virus in the body and ensure the safety of volunteers.”

The approval of the human ethics trial by the UK Ethics Committee comes the same week that the UK reached the target of offering a first dose of coronavirus vaccine to 15 million of its four main priority groups, including health workers, the elderly and those over 70 years of age.

There is an urgency in the deployment of the vaccine, given the concern about the spread of variants of the virus, with a particular strain that emerged in the UK late last year, now the dominant version in Britain, and that was detected in more than 80 countries around the world. However, so far preliminary studies have shown that current coronavirus vaccines are still effective against new variants of the virus.

Clive Dix, interim chair of the UK vaccine working group, commented that challenging trials in humans were vital to a better understanding of the virus and the effectiveness of vaccines.

“We have ensured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19. We hope these studies provide unique information on how the virus works and help us understand which vaccines Promising offers the best chance of preventing infection. “