UK plan to be first to run human challenge Covid trials

The UK is pushing ahead to be the first nation to carry out “human challenge” studies where up to 90 healthy people will be deliberately exposed to Covid.

The trials, which could begin in January, aim to speed up the race to get a Covid-19 vaccine.

The government is putting £33.6m towards the groundbreaking work. Safety will be a number one priority, experts insist. The plans will need ethical approval and sign-off from regulators before they can go ahead.

Human challenge studies provide a faster way to test vaccines because you don’t have to wait for people to be exposed to an illness naturally.

Researchers would first use controlled doses of the pandemic virus to discover what is the smallest amount that can cause Covid infection in volunteers aged 18 to 30.

These human guinea pigs, who will be infected with the virus through the nose and monitored around the clock, have the lowest risk of harm due to their young age and good health.

Next, scientists could test if a Covid vaccine prevents infection.

Could human challenge trials speed up the development of a coronavirus vaccine?

Lead researcher for the project Dr Chris Chiu, from Imperial College London, 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.”

Prof Peter Openshaw, co-investigator on the study and director of the Human Challenge Consortium, said deliberately infecting volunteers with a known human pathogen was “never undertaken lightly”.

“However, such studies are enormously informative.

“It is really vital that we move as fast as possible towards getting effective vaccines and other treatments for Covid-19.”

There are hundreds of Covid vaccines being developed around the world and several front-runners already in the final stages of testing, including one from Oxford University.

While some of these could get results and start to be used before the new trial has chance to begin, researchers say the work will still be useful, particularly for head-to-head studies to compare which vaccines work best.

Experts say we will probably need a few different vaccines, as well as effective treatments, to defeat Covid. They will also need to be tested in those at highest risk from Covid – the elderly and vulnerable.

The first stage of the human challenge project will be delivered by a partnership between Imperial College London, the Royal Free Hospital’s specialist and secure research unit in London and a company called hVIVO.

After exposure to Covid, the young volunteers will need to stay in a biosecure facility until they are no longer infectious.

They will be financially reimbursed for their time, and monitored for up to a year after taking part in the study to check for any side-effects.

Purposely infecting someone with Covid does pose an ethical dilemma, especially since there is no treatment to cure patients, although there are ones that might make it less deadly.

Prof Julian Savulescu, an expert in ethics at Oxford University, said the trials were justified: “In a pandemic, time is lives. So far, over a million people have died.

“There is a moral imperative to develop to a safe and effective vaccine – and to do so as quickly as possible.

“Given the stakes, it is unethical not to do challenge studies.”

Business Secretary Alok Sharma said: “We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine.”

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Even an effective coronavirus vaccine will not return life to normal in spring, a group of leading scientists has warned.

A vaccine is often seen as the holy grail that will end the pandemic.

But a report, from researchers brought together by the Royal Society, said we needed to be “realistic” about what a vaccine could achieve and when.

They said restrictions may need to be “gradually relaxed” as it could take up to a year to roll the vaccine out.

More than 200 vaccines to protect against the virus are being developed by scientists around the world in a process that is taking place at unprecedented speed.

“A vaccine offers great hope for potentially ending the pandemic, but we do know that the history of vaccine development is littered with lots of failures,” said Dr Fiona Culley, from the National Heart and Lung Institute at Imperial College London.

There is optimism, including from the UK government’s scientific advisers, that some people may get a vaccine this year and mass vaccination may start early next year.

However, the Royal Society report warns it will be a long process.

“Even when the vaccine is available it doesn’t mean within a month everybody is going to be vaccinated, we’re talking about six months, nine months… a year,” said Prof Nilay Shah, head of chemical engineering at Imperial College London.

The report said there were still “enormous” challenges ahead.

Some of the experimental approaches being taken – such as RNA vaccines – have never been mass produced before.

There are questions around raw materials – both for the vaccine and glass vials – and refrigerator capacity, with some vaccines needing storage at minus 80C.

Prof Shah estimates vaccinating people would have to take place at a pace, 10 times faster than the annual flu campaign and would be a full-time job for up to 30,000 trained staff.

“I do worry, is enough thinking going into the whole system?” he says.

Early trial data has suggested that vaccines are triggering an immune response, but studies have not yet shown if this is enough to either offer complete protection or lessen the symptoms of Covid.

UNANSWERED QUESTIONS ABOUT THE VACCINE
Prof Charles Bangham, chair of immunology of Imperial College London, said: “We simply don’t know when an effective vaccine will be available, how effective it will be and of course, crucially, how quickly it can be distributed.

“Even if it is effective, it is unlikely that we will be able to get back completely to normal, so there’s going to be a sliding scale, even after the introduction of a vaccine that we know to be effective.

“We will have to gradually relax some of the other interventions.”

And many questions that will dictate the vaccination strategy remain unanswered, such as:

Will one shot be enough or will boosters be required?
will the vaccine work well enough in older people with aged immune systems?
The researchers warn the issue of long-term immunity will still take some time to answer, and we still do not know if people need vaccinating every couple of years or if one shot will do.

Commenting on the study, Dr Andrew Preston from the University of Bath, said: “Clearly the vaccine has been portrayed as a silver bullet and ultimately it will be our salvation, but it may not be an immediate process.”

He said there would need to be discussion of whether “vaccine passports” are needed to ensure people coming into the country are immunised.

And Dr Preston warned that vaccine hesitancy seemed to be a growing problem that had become embroiled in anti-mask, anti-lockdown ideologies.

“If cohorts of people refuse to have the vaccine, do we leave them to fend for themselves or have mandatory vaccination for children to go to schools, or for staff in care homes? There are lots of difficult questions.”

“There’s not a question of life suddenly returning to normal in March.”