Researchers infect volunteers with coronavirus, in hopes of conquering Covid-19

So-called human provocation studies, which intentionally expose healthy people to viruses and other pathogens to study diseases, vaccines and treatments, are not new. Scientists around the world have used them for decades to assess the behavior of infections and drugs from the moment they enter the body.

But only the UK has taken the Covid-19 challenge trials forward, deliberately infecting volunteers to study a new and sometimes deadly disease that still holds many unknowns.

On March 8, Jacob Hopkins, 23, a British university student, watched researchers enter the airlocked entrance to his quarantine room at the Royal Free Hospital in London. They rolled a cart carrying a large red box, like a picnic cooler, labeled “biohazard”.

“It’s kind of like that scene from ‘Contagion’ – well, any scene from ‘Contagion’, really – all are wearing hazmat suits. [with] a little fan thing on the side, ”he said. He was lying on the bed with his head tilted back. A drop of the coronavirus was inserted into his left nostril, then his right. He stood there with his nose cut closed for about another 20 minutes.

Mr Hopkins kept an audio and visual diary during his quarantine at the hospital, providing details of his experiences. He said he volunteered to be infected in order to help scientists better understand the disease and, he hoped, to help end the pandemic sooner.

Days after the virus dripped into his nose, he was shivering with a mild case of Covid-19, the antiviral remdesivir pumped through a thin tube inserted into his arm. He spent 19 days in quarantine and said he felt fully recovered a month later. He will eventually be paid around £ 6,000, equivalent to $ 8,300, for that period, a year of follow-up testing and phone calls, and a parallel study he accepted. Trial payments are based on UK living wages and are ethically reviewed.

The trials were pushed back by health advisers and researchers at home and abroad. World Health Organization advisers and senior U.S. officials have questioned whether the potential benefits justify the risks. A big problem: the lack of a cure or proven “lifesaving treatment” to save lives if a test subject becomes seriously ill.

Ezekiel Emanuel, an American oncologist and bioethicist at the University of Pennsylvania, said the Covid-19 challenge trials might have made sense last year before several vaccines proved effective. But this year, he opposed the idea on ethical grounds. “It’s still a mystery to me what the ultimate justification is.”

Garth Rapeport, defender of challenge trials and former adviser to the UK Vaccine Taskforce, said skepticism abroad was high: “You can’t do this, it’s insane, it’s a deadly infection,” he said. he said he heard. specialist in viral respiratory infections, said the pandemic called for extraordinary measures and statistics showed that the trials could be carried out safely. “You had to take the emotion out of the situation,” he said.

A spokesperson for the UK Department of Health said the trials were being conducted in “a very safe and highly controlled environment and will deepen our understanding of pre- and post-symptomatic transmission of Covid-19”.

Matthew Memoli, director of the Infectious Diseases Laboratory at the U.S. National Institute of Allergy and Infectious Diseases in Bethesda, Md., Began planning a Covid-19 challenge trial last year before other officials of the US government did decide that it was too risky for the potential gain. But if the UK makes progress through its testing, he said, “it will change the perspective of people in the US”

All volunteers are between 18 and 30 years old and screened for known risk factors. They are isolated in quarantine suites with full-time medical care and specialized air systems to contain the virus. The researchers hope to publish the first peer-reviewed results of the first phase of the challenge trials by this fall.

Planning began in April 2020, led by researchers from Oxford University and Imperial College London, officials from the UK government-appointed vaccine task force and a small London-based biotechnology company called hVivo Services Ltd. specializing in contract drug testing.

Some of the scientists and hVivo have years of experience in human challenge trials. They say observing the early moments of Covid-19 infection will help develop new vaccines, measure the effectiveness of antiviral remedies, and help authorities prepare for the next pandemic.

Last year, the UK put in place ethical and regulatory reviews, with the government pledging more than $ 40 million in funding. A medical ethics panel approved the trials here in February.

Opinions were divided. In Oxford, a group of academics from medical schools pressured government health advisers to end planned trials, arguing the risks were too high and could damage the university’s reputation, according to people familiar with the discussions. As trial times lagged behind, supporters clashed over the design and speed of the study and release of the data, according to those involved.

The pace reflected caution, the government said. “The safety of volunteers in any clinical study is always paramount,” said the spokesperson for the UK Department of Health.

“Absolute determination finally got us there,” said Clive Dix, an executive and investor in a pharmaceutical company who served as vice chairman and then interim chairman of the UK Vaccine Task Force until April. This year.

Researchers hope the data from the trials will shed light on the durability of immune protection and how Covid-19 affects breathing, heart function, smell and concentration even before symptoms manifest. They say the model could test new vaccines and treatments face-to-face, eliminating weaker candidates before expensive, large-scale trials. Transmission data could help authorities prioritize who receives booster doses.

“It is already clear that we are going to learn a lot of things that could not be done otherwise,” said Helen McShane, a vaccine specialist at Oxford leading the university’s reinfection trial.

Researchers and the government say there have been no serious safety issues so far. The long Covid, involving prolonged symptoms like fatigue and shortness of breath, remains a concern, but researchers cite evidence that young volunteers should clear symptoms within months.

“You really need to make sure your participants understand that there is this little risk, although we’re pretty reassured,” said immunologist Christopher Chiu, lead investigator of the Imperial College challenge study.

So far, volunteers have been exposed to the original strain of the virus that first circulated in Wuhan, China. hVivo is working on manufacturing a Delta-variant version, a process that takes several months.

Meta Roestenberg, a medical scientist at Leiden University in the Netherlands, still hopes to persuade suspicious Dutch regulators to allow Covid-19 challenge trials there. “These studies provide so much data and information sometimes on things that you cannot imagine ahead of time,” she said. It also includes hesitation. “It is a societal decision to support this kind of work.”