Researchers are set to explore a human challenge study with the virus that causes COVID-19, the first such study anywhere in the world. The Human Challenge Programme is a partnership between Imperial College London, the Department for Business, Energy and Industrial Strategy (BEIS), hVIVO, a leading clinical company with expertise in viral human challenge models, and the Royal Free London NHS Foundation Trust. The researchers hope that the work will ultimately help to reduce the spread of the coronavirus, mitigate its impact and reduce deaths from COVID-19.

Reprinted for educational purposes and social benefit, not for profit. 

by Ryan O’Hare

20 October 2020

Source: ICL

The first stage of the project will explore the feasibility of exposing healthy volunteers to the SARS-CoV-2 coronavirus. The study would recruit volunteers between the ages of 18 and 30 with no previous history or symptoms of COVID-19, no underlying health conditions and no known adverse risk factors for COVID-19, such as heart disease, diabetes or obesity.

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 – Dr Chris Chiu – Imperial College London

In this initial phase, the aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19. This is known as a virus characterisation study.

Once this first phase is completed, clinical researchers aim to use this human challenge model to study how vaccines work in the body to stop or prevent COVID-19, to look at potential treatments and study the immune response.

Human challenge studies help clinical researchers establish which vaccines are most likely to succeed.

As the prevalence of COVID-19 rises and falls in populations, it can make it difficult for traditional vaccine trials to assess if vaccines work, because volunteers receiving the vaccine may not be naturally exposed to the virus.

Because a human challenge study deliberately infects the volunteers it should be possible for scientists to begin to establish efficacy very quickly, by testing if those who have had a vaccine are less likely to become infected with the virus.

Human challenge studies also make it possible for scientists to compare the efficacy of vaccine candidates by testing them side by side to establish which is more effective. At this early stage no specific vaccine candidates for the human challenge trials have been confirmed.

First steps

Initially, researchers will assess what amount of virus is needed to cause infection and elicit an immune response by slowly increasing the viral dose to which small groups of volunteers are exposed. The proportion of participants becoming infected and the amount of virus that they subsequently shed will be tracked to better understand the course of infection.

These ground-breaking but carefully controlled studies mark an important next step in building on our understanding of the virus and … will ultimately help in beginning our return to normal life – Alok Sharma – UK Business Secretary

As higher viral doses may be linked to more severe outcomes, the researchers are aiming to infect volunteers with the lowest possible dose to trigger viral replication but minimise symptoms.

Before leaving the residential clinical facility, volunteers would be required to test negative for the presence of SARS-CoV-2 in two separate laboratory tests, highly sensitive to the presence of virus.

Dr Chris Chiu, from the Department of Infectious Disease at Imperial College London and lead researcher on the human challenge studies, said: “Human challenge studies can increase our understanding of COVID-19 in unique ways and accelerate development of the many potential new COVID-19 treatments and vaccines.

“Our number one priority is the safety of the volunteers. 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.

“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.”

The human challenge study will be reviewed by a specially convened ethics committee before any volunteers are enrolled and the Medicines and Healthcare products Regulatory Agency (MHRA), an exemplar globally of medicines and device regulation, will be asked to approve the study before it is conducted.

Viral insights

Since the start of the global pandemic, doctors have learned a great deal about how the SARS-CoV-2 virus spreads and which groups may be at increased risk, as well as gaining clinical insights into treatments which can reduce the severity of disease and its complications.

However, despite these advances, there remain very few therapies for treating patients with COVID-19 and there is no effective vaccine available. Human challenge studies could be a crucial component of progressing research into treating and preventing the disease.

Human challenge studies could help clinical researchers to establish which COVID-19 vaccines are most likely to succeed. 

Professor Peter Openshaw, co-investigator on the study and Director of the MRC-funded Human Challenge Consortium (HIC-Vac) at Imperial College London said: “Deliberately infecting volunteers with a known human pathogen is never undertaken lightly. However, such studies are enormously informative about a disease, even one so well studied as COVID-19.

“It is really vital that we move as fast as possible towards getting effective vaccines and other treatments for COVID-19, and challenge studies have the potential to accelerate and de-risk the development of novel drugs and vaccines. These studies form a part of the global effort and play to a unique strength that we have at Imperial and in the UK”.

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.

“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life.”

The study is expected to begin early next year, with further details of volunteer recruitment and the study design to be published in the coming months.

Anyone interested in registering their interest in future COVID-19 human challenge study research should visit www.UKCovidChallenge.com

Royal Free London joins world-leading COVID-19 study partnership

20 October 2020

The Royal Free London (RFL) will play a key role in a world-leading partnership that is aiming to accelerate the development of vaccines and treatments for COVID-19.

The RFL has committed to the Human Challenge Programme, part of the government’s Vaccines Taskforce. It will be delivered through a partnership between RFL, government, Imperial College London, and hVIVO, an industry-leading clinical development services business that has pioneered human challenge models based upon viral challenge. The partnership is funded by the Department of Business, Energy, and Industrial Strategy.

Caroline Clarke, Royal Free London group chief executive, said: “We are proud to be part of this hugely important partnership, which we hope will advance the world’s understanding of COVID-19 as we look to rapidly develop life-saving vaccines and treatments. The Royal Free Hospital has a great history and tradition of treating and researching infectious diseases and our infectious diseases centre is renowned across the world for its work in this specialist area. We are looking forward to working alongside Imperial College London, BEIS, and hVIVO on such a vital piece of work over the coming months.”

The first stage of this project will explore the feasibility of exposing healthy volunteers to the coronavirus. In this initial phase, the aim will be to discover the smallest amount of virus it takes to cause a person to become infected. This is known as a virus characterisation study.

This will take place at the Royal Free Hospital (RFH)  and the study will be conducted under strict conditions – these include a controlled entrance to the facility, careful decontamination of waste and a dedicated laboratory for carrying out tests, all of which will help to ensure the study is delivered safely and securely. Air leaving the unit is also cleaned so there is no risk to anyone at the hospital or outside.

The safety of volunteers in any clinical study is always paramount; the partnership developing the human challenge model is working closely with the UK’s regulatory and ethics bodies to provide assurance that it is following established guidelines associated with clinical studies and that the design of the study minimises the risk of harm.

Subject to ethics approval, the first study would start in early 2021 and focus on identifying the lowest levels of the virus needed to infect healthy consenting adult volunteers.

There are a range of services that the RFH will provide to support the running of the study These include space rental, maintenance, utilities, cleaning, catering, portering and security.

The RFH will also provide pharmacy, pathology, radiology, and cardiology support which will ensure shared learning.

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.

“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life.”

Dr Chris Chiu, from the Department of Infectious Disease at Imperial College London and lead researcher on the human challenge study, said: “Human challenge studies can increase our understanding of COVID-19 in unique ways and accelerate development of the many potential new COVID-19 treatments and vaccines.

“Our number one priority is the safety of the volunteers. 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.

“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.”

Cathal Friel, Executive Chairman, Open Orphan, hVIVO’s parent company, said: “At Open Orphan we are pleased to be working on behalf of the UK Government and in partnership with two great institutions, Imperial College London and The Royal Free Hospital.

“Our subsidiary hVIVO is the world leader in the testing of vaccines and antivirals using human challenge studies and our contract with the UK Government to develop a COVID-19 human challenge study model will safely accelerate the discovery of effective vaccines and antivirals against COVID-19. We hope our work will not just be valuable for the Company but will also help to reduce the impact of COVID-19 on the population.

“Our thoughts go out to all those that have been affected by the global COVID-19 pandemic.”

For more information on human challenge studies please visit https://www.hic-vac.org/public-information/human-challenge-studies-coronavirus-towards-effective-vaccines