LONDON (Reuters) – Britain said on Tuesday it would back “human challenge” trials, where young and healthy volunteers are deliberately infected with COVID-19, to accelerate the development of vaccines for the disease.
The government said it would invest 33.6 million pounds ($43.5 million) in the studies in partnership with Imperial College London, laboratory and trial services company hVIVO and the Royal Free London NHS Foundation Trust.
If approved by regulators and an ethics committee, the studies would start in January with results expected by May 2021, the government said.
Britain’s hVIVO, a unit of pharmaceutical services company Open Orphan, said on Friday it was carrying out preliminary work for the trials.
Using controlled doses of virus, the aim of the research team will initially be to discover the smallest amount of virus it takes to cause COVID-19 infection in small groups of healthy young people, aged between 18 and 30, who are at the lowest risk of harm, the government said.
Up to 90 volunteers could be involved at the early stage, it said.
Imperial College’s Chris Chiu, lead researcher on the human challenge study, said the trials could increase understanding of COVID-19 in unique ways and accelerate development of the many potential new treatments and vaccines.
“Our number one priority is the safety of the volunteers,” he said. “My team has been safely running human challenge studies with other respiratory viruses for over 10 years. 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.”
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(Reporting by Paul Sandle; editing by Michael Holden)
LONDON — Scientists at Imperial College London plan to deliberately infect volunteers with the coronavirus early next year, launching the world’s first effort to study how vaccinated people respond to being intentionally exposed to the virus and opening up a new, uncertain path to identifying an effective vaccine.
The hotly contested strategy, known as a human challenge trial, could potentially shave crucial time in the race to winnow a number of vaccine candidates. Rather than conducting the sort of trials now underway around the world, in which scientists wait for vaccinated people to encounter the virus in their homes and communities, researchers would purposely infect them in a hospital isolation unit.
Scientists have used this method for decades to test vaccines for typhoid, cholera and other diseases, even asking volunteers in the case of malaria to expose their arms to boxes full of mosquitoes to be bitten and infected. But whereas the infected could be cured of those diseases, Covid-19 has few widely used treatments and no known cure, putting the scientists in charge of Britain’s study in largely uncharted ethical territory.
Starting with tiny doses, the scientists will first administer the virus to small groups of volunteers who have not been vaccinated at all, in order to determine the lowest dose of the virus that will reliably infect them. That process, scheduled to begin in January at a hospital in north London, will be followed by tests in which volunteers are given a vaccine and then intentionally exposed to this carefully calibrated dose of the virus.
The study will be led by scientists with Imperial College London and hVivo, a company specializing in human challenge trials. It still requires approval from Britain’s drug regulation agency, but the government said on Tuesday that it would allot 34 million pounds, or $44 million, in public funding.
The first round of volunteers, up to 90 healthy adults aged 18 to 30, will have the virus dripped into their noses without having been vaccinated. If not enough participants become infected, the scientists will try to expose these early-stage volunteers to a higher dose, repeating the process until they have identified the necessary exposure level of the virus.
Only once the scientists decide on a dose, which they intend to do by late spring, will they begin the process of comparing vaccine candidates by immunizing the next group of volunteers and then exposing them to the virus.
Some vaccine candidates now undergoing trials may already have received approval by then, but researchers hope a challenge trial will add direct evidence of efficacy and help them compare the performance of different vaccines.
“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly,” said Professor Peter Openshaw, an immunologist and co-investigator on the study. “However, such studies are enormously informative about a disease, even one so well studied as Covid-19.”
Many important questions about the study remain unanswered. The British government’s vaccine task force, which will select the first vaccine candidates to include in
LONDON (Reuters) – Britain will help to fund trials using a manufactured COVID-19 virus to deliberately infect young healthy volunteers with the hope of accelerating the development of vaccines against it.
The government said on Tuesday it will invest 33.6 million pounds ($43.5 million) in the so-called “human challenge” trials in partnership with Imperial College London, laboratory and trial services company hVIVO and the Royal Free London NHS Foundation Trust.
If approved by regulators and an ethics committee, the studies will start in January with results expected by May 2021, the government said.
Using controlled doses of virus, the aim of the research team will initially be to discover the smallest amount of virus it takes to cause COVID-19 infection in small groups of healthy young people, aged between 18 and 30, who are at the lowest risk of harm, the scientists leading the studies said in a briefing.
Up to 90 volunteers could be involved at the initial stages, they said, and virus to be used will be manufactured in labs at London’s Great Ormond Street Hospital.
Chris Chiu, an Imperial College scientist on the team, said the experiments would rapidly increase understanding of COVID-19 and the SARS-CoV2 virus that causes it, as well as accelerating development of potential new treatments and vaccines.
Critics of human challenge trials say deliberately infecting someone with a potentially deadly disease for which there is currently no effective treatment is unethical.
Business Secretary Alok Sharma said the trials would be carefully controlled and marked an important next step in building understanding of the virus and accelerating vaccine development.
Chiu said the plan for initial studies – which are aimed at assessing how much virus it takes to infect someone with COVID-19 – is to immediately treat volunteers with the Gilead antiviral drug remdesivir as soon as they are infected.
He said that while studies have show remdesivir has little or no effect on severe COVID-19 cases, his team has a “strong belief” that it will be an effective treatment if given in the very earliest stages of infection.
A spokeswoman for the World Health Organization said that there are “very important ethical considerations” when approaching such human challenge trials.
“What is critical is that if people are considering this, it must be overseen by an ethics committee and the volunteers must have full consent. And they must select the volunteers in order to minimise their risk,” she told reporters in Geneva.
Chiu said his team’s “number one priority is the safety of the volunteers”.
“No study is completely risk free, but (we) will be working hard to ensure we make the risks as low as we possibly can,” he said.
Britain’s hVIVO, a unit of pharmaceutical services company Open Orphan, said last week it was carrying out preliminary work for the trials.
Reporting by Kate Kelland and Paul Sandle in London, with additional reporting by Stephanie Nebehay in Geneva, Editing by Michael Holden and Angus MacSwan
LONDON (AP) — U.K. researchers are preparing to infect healthy young volunteers with the virus that causes COVID-19, becoming the first scientists to use the controversial technique to study the disease and potentially speed up development of a vaccine that could help end the pandemic.
This type of research, known as a human challenge study, is used infrequently because some consider the risk involved in infecting otherwise healthy individuals to be unethical. But researchers racing to combat COVID-19 say that risk is warranted because such studies have the potential to quickly identify the most effective vaccines and help control a disease that has killed more than 1.1 million people worldwide.… Read More
The United States is moving more cautiously, with leading government researchers saying human challenge trials might be too risky or unnecessary. But the British scientists say the potential payoff is massive — that accelerating vaccine development by even three months could save 100,000s of lives globally.
The British experiment is scheduled to begin in January. Volunteers will be given a laboratory-grown strain of the live virus while quarantined in a secure unit at the Royal Free Hospital in London, where they will undergo daily, even hourly, tests.
The initial phase of the study, involving 50 to 90 healthy young adults, between ages 18 and 30, will seek to determine the minimal amount of virus necessary to cause an active, measurable infection.
Later in the spring, the scientists hope to enlist more volunteers, who will be inoculated with promising vaccines and then exposed to the virus to see how well the vaccines protect them.
Andrew Catchpole, chief science officer for hVIVO, a commercial pharmaceutical company that will recruit the volunteers, manufacture the challenge strain of the virus and conduct the tests, said the human challenge study will be reviewed by a specially convened ethics committee and Britain’s Medicines and Healthcare products Regulatory Agency, its version of America’s Food and Drug Administration.
Catchpole told The Washington Post it is not yet known which vaccines may be tested. He said possible candidates include those vaccines that have proven themselves in large-scale Phase 3 trials or they may be earlier in their development but potentially more effective.
Hedging its bets, the British government has signed an agreement for 100 million doses of a vaccine being trialed by Oxford University and AstraZeneca, as well as inking deals with Pfizer, Sanofi and Valneva.
The safety data gained from large, Phase 3 trials will still be essential to show the vaccines are ready to be deployed in large populations. But the British government hopes challenge trials will help accelerate the study of vaccines in mid-stages of development.
Catchpole said the major advantage is “you get efficacy data so much sooner” than trials that rely on chance exposure. If there is not much virus circulating in a population, it could take months and tens of thousands of inoculations to prove efficacy.
Challenge experiments have a long history in biomedical research, dating back to Edward Jenner’s development of a smallpox vaccine in 1796. In the modern era, challenge trials have been used extensively to study and find treatments for influenza, malaria, typhoid, dengue fever and cholera.
Covid-19, though, is different. Without a medication to reliably “rescue” volunteers from the disease, many scientists are hesitant to infect people.
Although physicians have more treatments for hospitalized patients than they did at the beginning of the pandemic, there isn’t yet an approved drug to stop recently infected people from developing a severe case.
The challenge trial participants will be given the antiviral drug remdesivir, which President Trump took when hospitalized for covid-19 and which has been approved or authorized for temporary use