HUMAN volunteers will be deliberately infected with Covid-19 in order to speed up the hunt for a vaccine, officials have confirmed.
A small number of young healthy volunteers will be recruited to take part in the trial at the start of 2021.
Healthy volunteers will be injected with a small amount of Covid-19 in a new trial [/caption]
The government is backing the studies and has invested £33.6 million to back the project in conjunction with Imperial College London, hVIVO and the Royal Free London NHS Foundation Trust.
It is hoped these studies will help speed up vaccine development.
A group of up to 90 volunteers, aged 18 to 30 will be exposed to the virus in a controlled environment.
The participants will be monitored to establish how much of the virus it takes to cause Covid-19 but not serious illness.
The so-called “human-challenge” trials will begin in the new year with the results expected in May 2021.
Young, healthy people are at lowest risk from harm from the virus and the phase after these trials will be to test vaccines.
The trials will be carried out at the Royal Free Hospital in London, with participants being compensated for their involvement.
The volunteers will be tracked for a year and business secretary Alok Sharma said that backing the “best and brightest” scientists would help the search for an effective vaccine.
He said the funding announced today marks an important next step in building on our understanding of the virus.
This he said will “ultimately help in beginning our return to normal life”.
Lead researcher on the human challenge study Dr Chris Chiu, from Imperial College London said the top priority is the safety of volunteers.
Dr Chiu said: “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.
“The UK’s experience and expertise in human challenge trials, as well as in wider Covid-19 science, will help us tackle the pandemic, benefiting people in the UK and worldwide.”
Other experts have said the tests will help improve the understanding of the virus and Professor Jonathan Van-Tam added that human challenge studies can help pick out the most promising ones to take forward into larger phase three trials.
He added: “Second, for vaccines which are in the late stages of development and already proven to be safe and effective through phase three studies, human challenge studies could help us further understand if the vaccines prevent transmission as well as preventing illness.”
Peter Openshaw, from Imperial College London, said the initial part of the trial will involve exposing people to the virus to establish the lowest possible safe dose.
“Initially, until May next year, we are expecting to escalate the dose and ascertain the exact safety.
“Once that’s done we will be ready to actually test vaccines head to head and compare different vaccines,” he said.
Speaking to BBC Radio 4’s Today Programme he explained that volunteers would be infected via the nose and then monitored “very carefully”.
“(These studies) are enormously informative because we can do such very, very careful monitoring under controlled conditions,” he added.
What are challenge trials and can they help prevent disease?
Prof Gordon Dougan FMedSci FRS, Department of Medicine, University of Cambridge explains how challenge trials work.
He said that trials like this have been used for decades to assess both the infection itself or to develop new preventative vaccines.
“In the past few years they have moved back onto the developmental and more importantly regulatory path for licensing vaccines.
“This is in part because we are developing a strong ethical framework for managing such trials and also collecting detailed data from them.
“They have been influential in developing vaccines for diseases such as cholera, malaria and typhoid.”
Prof Gordon said assessing viruses is more challenging than bacteria.
“In any trial it is very important to risk assess the impact of the infection on the volunteer but also to have some form of rescue therapy if problems appear.
“For bacteria, antibiotics can be used. For viruses, more challenging.”
“The aim of these studies is not to make people ill, but to get the virus to replicate in the nose.
“We think that, by taking every precaution, we can really limit the infection and then we should be able to do it quite safely given the vast amount of experience we have in this field.”
Health secretary Matt Hanock had previously hinted that a vaccine would be ready before Christmas, but Sir Patrick Vallance, the government’s chief scientific adviser said that it would be unlikely that a vaccine would stop the disease completely.
Many have pinned the promise of a return to normal life on a vaccine, which in the first instance would be given to NHS workers and the most vulnerable.
Sir Patrick added that only one disease – smallpox – had ever been completely eradicated.
Dr Doug Brown, Chief Executive of the British Society for Immunology, said it’s important to note that these trials are not risk free.
He added that there are still not many treatments available for those who become very sick with the illness.
He continued: “The research team will be acutely aware of this and there will be many stages to this project all aimed at minimising risk of harm to volunteers – this starts with finding out the minimum amount of virus needed to infect each individual.”