The nurse prepares doses of the Covid-19 vaccine.
Alessandra Benedetti – Corbis | Corbis News | Getty Images
LONDON – The UK is expected to be the first country in the world to conduct a “human challenge” Covid-19 study, after approval by the country’s clinical trial ethics body.
Covid-19’s first human challenge test will see up to 90 volunteers, aged 18-30, exposed to Covid-19 “in a safe and controlled environment to increase understanding of how the virus affects people,” said the government. British in a statement Wednesday.
The researchers are calling on healthy young people, who have the lowest risk of complications from the coronavirus, to volunteer for the study. Volunteers will be compensated for the time they spend on the study, which should start in a month.
The study is being supported by a £ 33.6 million ($ 46.6 million) investment from the British government, with the trial being conducted by a partnership between the government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the clinical company hVIVO, which pioneered models of human viral challenge.
How it works
The study will involve establishing the least amount of virus needed to cause infection (known as a virus characterization study) with exposed volunteers “in a safe and controlled environment,” the government said.
“The safety of volunteers 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 of low risk in healthy young adults,” he 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 coronavirus and identify factors that influence how the virus is transmitted, including how a person infected with Covid-19 transmits infectious viral particles to the environment.
Once the initial study has been carried out, participants can receive an approved vaccine and then be exposed to the Covid-19 virus to identify the most effective vaccines.
Considerations
These studies are controversial, as participants are deliberately exposed to pathogens, but are seen as playing a key role in the development of effective vaccines and treatments.
“Over many decades, human challenge studies have been carried out safely and have played important roles in accelerating the development of treatments for diseases such as malaria, typhoid, cholera, norovirus and flu,” noted the British government.
The guidance of the World Health Organization says that tests with humans are ethical when they meet certain criteria. The protections must be clearly implemented, experts said, including that trial participants are relatively young and in good health and should receive the highest quality medical care with frequent monitoring.
WHO notes that it is essential that challenge tests are “conducted within an ethical framework in which truly informed consent is given” and that they should be carried out with “abundant foresight, caution and supervision”.
Potential individual risks and benefits must be considered, says WHO, as well as potential social benefits and risks, such as the release into the environment of a pathogen that would not otherwise be present.
The UK human challenge test will take place in the coming weeks in the specialized and secure clinical research facilities of the Royal Free Hospital in London. These facilities “are designed specifically to contain the virus. Highly trained doctors and scientists will be available to carefully examine how the virus behaves in the body and to ensure the safety of volunteers. ”
Race against variants
The UK Ethics Committee’s human challenge test approval comes in the same week that the UK has achieved its goal of offering a first dose of a coronavirus vaccine to 15 million people in its four priority groups , including health professionals, the elderly and over 70 years old.
There is an urgency to launch the vaccine due to concerns about the spread of virus variants, with a specific strain that emerged in the UK late last year now being the dominant version in Britain and detected in more than 80 countries in Worldwide. However, to date, preliminary studies have shown that current vaccines against coronavirus are still effective against new variants of the virus.
Clive Dix, acting chairman of the UK Vaccine Task Force, commented that testing on humans was vital to better understanding the virus and vaccine effectiveness.
“We ensure a range 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 that these studies will offer a unique insight into how the virus works and help us understand which vaccines promising offer the best chance of preventing infection. “