Covid-19 Challenge Trial to Infect Healthy Volunteers in the UK

The United States is moving more cautiously, with major government researchers saying that human challenge trials can be too risky or unnecessary. But British scientists say the potential rewards are enormous. Accelerating vaccine development for as long as three months can save the lives of hundreds of thousands of people around the world.

The UK experiment is scheduled to begin in January. Volunteers infused laboratory-grown purified strains of live virus into their noses while isolated in a 22-bed biosecure unit at the Royal Free Hospital in London, 2-3 daily and even hourly. I will be inspected several times. several weeks.

In the early stages of a study of less than 100 healthy young adults between the ages of 18 and 30, determine the minimum amount of virus needed to cause an active and measurable infection in the upper respiratory tract. will do.

Scientists hope to get more promising vaccines in late spring and recruit more volunteers to see how well the vaccine protects them by exposing them to the virus.

Andrew Catchpole, Chief Science Officer of hVIVO, a commercial pharmaceutical company that recruits volunteers, manufactures and tests challenge strains of the virus, said that human challenge research was conducted by a specially convened Ethics Committee and the UK Pharmaceutical Department. Said it will be reviewed. Healthcare Product Regulatory Agency, its version of the US Food and Drug Administration.

Catchpole told The Washington Post that it was not yet known which vaccine would be tested. He said potential candidates include vaccines that have been proven in large-scale Phase 3 trials, or may be in the early stages of development but potentially more effective.

“It could be a direct comparison study,” said Catchpole, who will be able to compare established vaccines with moderate efficacy to new, state-of-the-art vaccines in the future. I think.

The UK government has hedged its bet and signed 100 million doses of vaccine tested in trials by the University of Oxford and AstraZeneca, as well as contracts with Pfizer, Sanofi and Barneva.

Safety data from large Phase 3 trials are still essential to show that the vaccine is ready for deployment in large populations. However, the UK Government hopes that the Challenge Trial will help accelerate vaccine research in the middle of development.

According to Catchpole, the main advantage is that “effectiveness data can be obtained much faster” than trials that rely on accidental exposure. If there are not many viruses circulating in the population, millions of dollars of research can require months to tens of thousands of doses to prove efficacy.

Christopher Chiu, an immunologist at Imperial College, one of the principal investigators of the study, said the British human challenge model could tell how effective it would be within 10 weeks. Coronavirus The vaccine is.

The Challenge experiment has a long history in biomedical research since Edward Jenner developed the smallpox vaccine in 1796. In modern times, challenge trials have been widely used to study and discover treatments for influenza, malaria, typhoons, dengue fever, and cholera.

However, Covid-19 is different. Many scientists are hesitant to infect people without drugs to ensure that volunteers are “rescued” from their illness.

Physicians have more treatment for inpatients than at the onset of the coronavirus pandemic, but have been approved to prevent recently infected people from developing severe cases of covid-19. I don’t have any medicine yet.

President Trump will administer the antiviral drug remdesivir to participants in the Challenge Trial. Taken on admission This month’s covid-19 has been approved or approved For temporary use Treat covid-19 in more than 50 countries.But the World Health Organization Recently reported In large clinical trials in 30 countries, remdesivir had no substantial effect on mortality. The study has not yet been peer reviewed.

Some people Develop long-term complications From covid-19. However, little is known about how to predict who will be a “long-haul carrier” of covid-19 or how persistent those symptoms will be.

“Youth are immune to the consequences,” Francis Collins, director of the National Institutes of Health, told The Washington Post last week. “Is it really justified to intentionally infect someone, regardless of their current health? Ethically, I think it’s a very open question.”

Scientists, pharmaceutical companies, and governments can be accused and accused of being reckless if a clinical subject becomes seriously ill or dies in a UK challenge trial. Public support for clinical trials and new vaccines can also be hit.

Nonetheless, Alastair Fraser-Urquhart, Petition Project Manager 1 day early, Collected signatures from more than 38,000 people wishing to volunteer.

“Why? Basically altruism,” he said.

Fraser-Urquhart tells healthy young people like himself that “the risk is low and the potential benefits are enormous.”

He said young people wouldn’t want to live in a pandemic-constrained world longer than necessary. They also want to help older people who are susceptible to serious cases of covid-19. However, some question how a healthy 20-something experience in a challenge trial can actually be predicted by older people with high blood pressure. The pressure will work.

Fraser-Urquhart suggested that volunteers should be paid for their time. Probably $ 5,000 for a few weeks with quarantine and a year’s follow-up test.

“There should be no out-of-pocket costs or financial incentives,” he said.

He added that the British government “deserves praise for going to places that no one wants to go.” This is the first thing to try. “

“It is never easy to deliberately infect volunteers with known human pathogens,” said Peter Openshaw, an immunologist at Imperial College London and a collaborator at the Human Challenge Consortium.

However, “It is very important to act as soon as possible to obtain effective vaccines and other treatments for covid-19. Challenge research accelerates the development of new drugs and vaccines and reduces risk. There is a possibility.”

Dominique Wilkinson, a professor of medical ethics at Oxford University, says volunteers increase risk, but instead of starting from scratch, they are exposed to new strains of the new coronavirus that are already widespread in the UK, especially young people. I said I would.

“What is the risk of a trial compared to the risk of living in London or going to college?” He asked.

With that in mind, he said the need for human challenge testing was clear.

“You may get a vaccine and you may learn which vaccine is the most efficient,” he said, when thousands of people around the world die every day.Global Coronavirus Deaths passed 1.1 million.

In the United States, the government has funded researchers at Colorado State University, Potential challenge stock Of the coronavirus that can be used if such an experiment is needed.

Creating a challenge strain will take several months and will reach a decisive milestone indicating whether the vaccine will work by the end of this year or by the beginning of next year in some large US countries. Vaccine trials require resources for many scientists.

“In my opinion, this is even less likely to be needed than it was a few months ago,” said Collins of NIH. “The idea that we needed to be prepared for it was to face the possibility that the viral pandemic would actually disappear and there would not be enough illness to spread to the community.”

Johnson reported from Boulder, Colorado.