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 Covid-19 study on “human challenge”, after approval by the country’s clinical trials ethics body.

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

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

The study is backed by a £ 33.6 million ($ 46.6 million) investment from the UK government, the process being delivered by a partnership between Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the clinical company. hVIVO, which pioneered viral human challenge models.

The study will involve determining the smallest amount of virus needed to cause the infection (known as the virus characterization study) with volunteers exposed “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,” he added. Doctors and scientists will closely monitor the effect of the virus on volunteers and will be on hand 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 who is infected with Covid-19 transmits infectious virus particles into the environment.

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

Such studies are not without controversy, given that participants are deliberately exposed to pathogens, but are seen as playing a key role in the development of effective vaccines and treatments.

“Over several decades, human challenge studies have been conducted safely and have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and influenza,” the British government said.

The World Health Organization’s instructions say that attempts at human challenge are ethical when they meet certain criteria. The protections should be clearly in place, experts said, including that study participants are relatively young and in good health and receive the highest quality medical care, with frequent monitoring.

WHO notes that it is essential that the tests be “conducted in an ethical framework in which truly informed consent is given” and that they should be undertaken with “great thought, caution and supervision”.

Both potential individual risks and benefits, says WHO, and potential social benefits and risks, such as the release into the environment of a pathogen that might not otherwise be present, must be considered.

The study of the human challenge in the UK will take place over the next few weeks at the Royal Free Hospital and secure clinical research facilities in London. These facilities “are specially designed to contain the virus. Highly trained doctors and scientists will be on hand to carefully examine how the virus behaves in the body and to ensure the safety of volunteers.”

Approval for the human challenge test from the UK Ethics Committee comes in the same week that Britain reached its goal of delivering a first dose of coronavirus vaccine to 15 million people in the top four priority groups, including workers. in the field of health, the elderly and over 70 years.

The launch of the vaccine is urgent, given concerns about the spread of virus variants, with a special strain that appeared in the UK late last year, now the dominant version in the UK and detected in over 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, the interim chair of the UK Vaccine Working Group, commented that challenging studies in humans have been vital to better understanding the virus and the effectiveness of vaccines.

“We have provided 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 expect these studies to provide unique insights into how the virus works and to help us understand which promising vaccines offer the best chance of preventing infection. “