Oct. 20 (UPI) — The British government has signed a contract with a pharmaceutical services company for the first COVID-19 human challenge study where healthy volunteers will be exposed to the virus to test a vaccine.
The company Open Orphan on Tuesday announced the deal worth up to $13 million for its hVIVO subsidiary to conduct the initial characterization study, which is expected to be completed by May 2021, to identify the “most appropriate dose” of COVID-19 volunteers can be exposed to in the trials.
The study, done in partnership with the Imperial College London, will be conducted at the Royal Free Hospital’s specialist research unit in the British capital, Open Orphan said in the announcement.
“We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine,” Alok Sharma, Britain’s secretary of State for Business, Energy and Industrial Strategy, said in a statement.
“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines, which will ultimately help in beginning our return to normal life,” Sharma added.
The Imperial College London said in a statement the study would recruit volunteers between 18-30 years old with no history of COVID-19, underlying health conditions or issues, such as heart disease, diabetes or obesity, that pose risk factors to the coronavirus.
The college said human challenge studies aid researchers in establishing which vaccines are most likely to be effective and provide data on the efficacy of vaccine candidates by testing them side by side.
“Human challenge studies can increase our understanding of COVID-19 in unique ways and accelerate development of the many potential new COVID-19 treatments and vaccines,” said Dr. Chris Chiu of the Department of Infectious Disease at the Imperial College London and lead researcher on human challenge studies.
Human challenge trials are medical trials in which healthy volunteers are intentionally “challenged” with an infectious disease in the process of developing a vaccine.
They have been conducted over hundreds of years and have contributed to important scientific knowledge, the World Health Organization said, adding that such research “can appear to be in conflict with the guiding principle in medicine to do no harm.”
In guidance published in May concerning the ethics of challenge studies for COVID-19 vaccines, the WHO said that despite the need for more information, such studies would pose the least risk to young healthy adults between 18-30 years old as their hospitalization rates are estimated at 1% and fatal infections rates at .03%.
The WHO added that the risk of challenge trials for COVID-19 are believed to higher than others because the “pathogenesis of COVID-19 is currently poorly understood, … there is no specific treatment available and severe disease or death can occur in young adults.”
Chiu said that their top priority will be the safety of the volunteers.
“No study is completely risk free, but the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can,” he said.
A website for the challenge is currently recruiting those to join the study.