The UK makes use of Open Orphan to check vaccination trials that contain volunteers being contaminated with coronavirus


A volunteer is injected with a vaccine while participating in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America in Hollywood, Florida, United States, on September 24, 2020.

Marco Bello | Reuters

Healthy young people in the UK may soon be asked to volunteer to intentionally come into contact with Covid-19 as part of a series of human challenge studies aimed at speeding up the process of vaccine development.

These studies, which are controversial in medical circles, essentially ask volunteers to be "challenged" with an infectious disease organism. The idea behind this is to recruit healthy young people, vaccinate them, and then expose them to the virus to see if the vaccine is effective. Proponents say such studies can speed up vaccine development, while others say these studies raise ethical questions.

The UK government took a first step this week by signing a contract with a pharmaceutical services company called Open Orphan for a so-called characterization study that will determine the most appropriate dose of the virus for future human challenge studies. In practice, this means that researchers will determine the lowest dose of the virus that will still show positive on a standard polymerase chain reaction or PCR test.

The characterization study is expected to be completed in 2021 and is pending ethical and regulatory approval. The study, funded by Imperial College in the UK, is being carried out by Open Orphan's hVivo division at a London-based research site.

The government has also secured the first three slots to test vaccines using human challenge studies. It remains to be decided whether these studies will advance.

"In traditional vaccine trials, all subjects are vaccinated and sent out to lead their normal lives," said Andrew Catchpole, hVivo's chief scientist. "But the result is that most of them are not naturally exposed. So you are bound by how much disease is spreading in this community."

Catchpole says hVivo is already safely conducting more human challenge studies for other diseases than any other company in the world.

The volunteers taking the study model must be between 18 and 30 years old, Catchpole said. Her general health will be checked for possible risk factors, he said. The study is not open to pregnant women or nursing mothers.

It remains unclear how many people will raise their hands, but in other countries like the US many have already expressed their willingness to participate in such attempts.

Medical experts around the world have mixed views on human challenge studies.

"I think they could speed up the process and be in the middle of a pandemic, so it's worth thinking about, even though they're risky and ethically controversial," said Arthur Caplan, professor of bioethics at New York University.

Infecting a person with a virus that could have adverse health effects is against the "do no harm rule," said Caplan.

However, the risks can be minimized as much as possible by starting with the youngest and healthiest people who are far less likely to develop serious illness. Participants typically receive post-exposure antiviral therapies such as Remdesivir from Gilead Sciences. However, it's worth noting that recent studies have questioned the effectiveness of these drugs.

Others say these studies may not be necessary, especially given the potential harm.

"Given that we may have an approved vaccine in the months ahead, I don't know how much challenge studies would speed up the process," said Dr. Jeremy Faust, a Boston-based ambulance. "There is an opportunity here to endanger people without much benefit."


Steven Gregory