The United Kingdom has given the go-ahead to a government-funded “human challenge study” that will see a small number of young and healthy adult participants deliberately infected with the SARS-CoV-2 virus, the coronavirus strain that causes COVID-19.
The challenge study, which can begin in the coming weeks, will involve infecting several dozen people with a small amount of virus, with the goal of increasing the scientific understanding of transmission factors and the minimum amount of coronavirus that can cause infection in humans. A website for the challenge study describes the process as such: “The Human Challenge Model is a study during which healthy volunteers are deliberately exposed to a virus, known as the ‘challenge virus.’ This is different to standard vaccine clinical trials where volunteers are exposed to viruses naturally. The Human Challenge Model can provide a more efficient and faster way to develop vaccines as fewer volunteers are required.”
The study, which just received ethics approval, will compensate participants for an unspecified amount. All of the study participants must be healthy and between the ages of 18 and 30 to join.
“We are asking for volunteers aged between 18 and 30 to join this research endeavour and help us to understand how the virus infects people and how it passes so successfully between us,” Chief Investigator Dr. Chris Chiu, of the Imperial College London, said in a statement Wednesday. “Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work.”
Clive Dix, interim chair of the U.K. vaccines task force, recently said that the government expects to have enough supply for every adult in the country to receive two doses of vaccine by September, and possibly sooner, according to SkyNews. The human trials, suggested Dix, would be an effort to develop additional treatments and vaccines against COVID-19.
“We have secured a number of safe and effective vaccines for the U.K., but it is essential that we continue to develop new vaccines and treatments for Covid-19,” said Dix in a statement. “We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.”
In a press release, the U.K. government said of these types of human trials:
Over many decades, human challenge studies have been performed safely and have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and flu. The trials have also helped researchers establish which possible vaccine is most likely to succeed in phase 3 clinical trials that would follow, usually involving thousands of volunteers.
This initial study will also help doctors understand how the immune system reacts to coronavirus and identify factors that influence how the virus is transmitted, including how a person who is infected with Covid-19 virus transmits infectious virus particles into the environment.
The trial will be conducted in partnership with the U.K., Imperial College London, the Royal Free London NHS Foundation Trust, and hVIVO, a company that has conducted so-called human challenge trials in the past for other viruses.