UK strikes deal with open orphan to study coronovirus ‘challenge’

A volunteer is injected with the vaccine as he participates in a coronavirus disease (COVID-19) vaccination study at the US Research Centers in Hollywood, Florida, US, September 24, 2020.

Marco Bello | Reuters

Healthy, young people in the UK may soon be asked to volunteer to consciously uncover Kovid-19 as part of a set of human challenge studies aimed at speeding up the process of vaccine development.

These studies, which are controversial in medical circles, essentially call for volunteers with an infectious disease organism to “challenge” them. The idea behind them is to recruit healthy, young people, vaccinate them and then later expose them to the virus to determine if the vaccine is effective. Proponents say such studies could trigger vaccine development, while others say these tests raise ethical questions.

The UK government has taken an initial step this week by signing a contract with a pharmaceutical services company called Open Orphan for an initial characterization study to identify the most suitable dose of virus for use in future human challenge studies Is included. In practice, this means researchers will determine the lowest dose of 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 still subject to ethical and regulatory approval. The study will be carried out by the hVivo unit of the Open Orphan at a research site in London, sponsored by Imperial College in the UK.

The government has also acquired the first three slots to test vaccines using human challenge studies. It is still to be determined whether these studies will proceed.

“In traditional vaccine trials, all subjects are vaccinated and sent out to live their normal lives,” said HVCHO Chief Scientific Officer Andrew Catchpole. “But the result is that most are not exposed naturally, so how much disease are you spreading in that community.

Catchpole said that hVivo already operates more human challenge studies for other diseases than any other company globally.

Catchpole stated that volunteers participating in the study model must be between 18 and 30 years of age. He said that his general health would be checked for any risk factors. The study is not open to pregnant women or nursing mothers.

It is unclear how many people will raise their hands, but in other countries, such as the US, large numbers have already expressed willingness to participate in such trials.

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

“I think they can accelerate between the process and an epidemic, so it’s worth considering that they’re risky and morally controversial,” said Arthur Caplan, professor of bioethics at New York University.

Infecting a person with a virus that can have consequences for their health violates the “no harm rule”, Caplan explained.

But the risk can be minimized by starting with the youngest, healthiest people, who are less likely to become seriously ill. Participants are typically given antiviral therapy, such as remodevir of Gilead Sciences, after exposure. It is worth noting, however, that recent studies have questioned the efficacy of these drugs.

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

“Given that we may have an approved vaccine in the coming months, I have no idea how much challenge the process will have with this process,” Dr. Said Jeremy Faust, a Boston-based emergency medicine physician. “There is a possibility of putting people at risk without going up a lot.”


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