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Nearly four months ago, in UK Approves Human COVID-19 Vaccine Challenge Studies, we looked at the UK's plan to recruit young, healthy volunteers between the ages of 18 to 30 to participate in a two pronged COVID challenge study.
Under normal circumstances it can take years to assess the effectiveness of a new vaccine, as thousands of volunteers much be vaccinated and then followed for months - or even years - to see if they are (statistically) less likely to be infected than unvaccinated members of the community.The first goal was to determine the minimum infectious dose of COVID, and the second was to test the ability of various vaccines to prevent infection.
Human challenge studies, while controversial (see Public Health Ethics Ethical Criteria for Human Challenge Studies in Infectious Diseases), can literally shave months, or even years, off the vaccine evaluation process.
At least to start, subjects will only be exposed to the older, believed to be less serious, `wild type' COVID which has been circulating in the UK since March of 2020. Once the safety of those trials can be assured, other variants may be considered.
We've three stops. First, excerpts from the UK government's announcement yesterday, followed by a press release from Imperial College London, and lastly a link to expert reactions on the Science Media Centre website.
Press release
World's first coronavirus Human Challenge study receives ethics approval in the UK
The UK will be the first country in the world to run a Covid-19 human challenge study, following approval from the UK’s clinical trials ethics body
Published 17 February 2021
From: Department for Business, Energy & Industrial Strategy and The Rt Hon Kwasi Kwarteng MP
- First Covid-19 human challenge study will begin within a month, after receiving ethics approval in the same week the UK hits target of offering first dose to 15 million people
- Researchers call on healthy young people to volunteer for the study, which will play a key role in developing effective Covid-19 vaccines and treatments
- Up to 90 volunteers aged 18 - 30 years will be exposed to Covid-19 in a safe and controlled environment to increase understanding of how the virus affects people
Backed by a £33.6 million UK government investment, the first-of-its-kind study for this virus will involve establishing the smallest amount of virus needed to cause infection, which will give doctors greater understanding of Covid-19 and help support the pandemic response by aiding vaccine and treatment development.
Due to begin in the next few weeks, it will involve up to 90 carefully selected, healthy adult volunteers being exposed to the virus in a safe and controlled environment.
The safety of volunteers is paramount, which means this virus characterisation study will initially use the version of the virus that has been circulating in the UK since March 2020 and has been shown to be of low risk in young healthy adults. Medics and scientists will closely monitor the effect of the virus on volunteers and will be on hand to look after them 24 hours a day.
The researchers are also working very closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not impact on the NHS’ ability to care for patients during the pandemic. The study will not begin without their go-ahead.
Once this initial study has taken place, vaccine candidates, which have proven to be safe in clinical trials, could be given to small numbers of volunteers who are then exposed to the Covid-19 virus, helping to identify the most effective vaccines and accelerate their development.
Researchers are encouraging people aged between 18 and 30 years old, who are at the lowest risk of complications resulting from coronavirus, to volunteer for this vital study. Volunteers will be compensated for the time they spend in the study.
Business Secretary Kwasi Kwarteng said:"Researchers and scientists around the world have made incredible progress in understanding Covid-19 and developing critical vaccines to protect people.""While there has been very positive progress in vaccine development, we want to find the best and most effective vaccines for use over the longer term. These human challenge studies will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of vaccines."
Over many decades, human challenge studies have been performed safely and have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and flu. The trials have also helped researchers establish which possible vaccine is most likely to succeed in phase 3 clinical trials that would follow, usually involving thousands of volunteers.
This initial study will also help doctors understand how the immune system reacts to coronavirus and identify factors that influence how the virus is transmitted, including how a person who is infected with Covid-19 virus transmits infectious virus particles into the environment.
The Human Challenge study is being delivered by a partnership between the government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the industry-leading clinical company hVIVO, which has pioneered viral human challenge models.
The Royal Free Hospital’s specialist and secure clinical research facilities in London are specifically designed to contain the virus. Highly trained medics and scientists will be on hand to carefully examine how the virus behaves in the body and to ensure the safety of volunteers.
The virus being used in the characterisation study has been produced by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, in collaboration with hVIVO with support from virologists at Imperial College London.
From Imperial College London:
Call for volunteers for world’s first coronavirus human challenge study
by Laura Gallagher 17 February 2021
The UK will be the first country to run a Covid-19 human challenge study, following a favourable opinion from the UK’s clinical trials ethics body.
Backed by a £33.6 million UK government investment, the study will be delivered by a partnership between Imperial College London, the Royal Free London NHS Foundation Trust and the clinical company hVIVO.
The initial study will help scientists understand how the immune system reacts to coronavirus (the virus that causes Covid-19), and identify factors that influence how the virus is transmitted - including how a person who is infected ‘sheds’ infectious virus particles into the environment.
It will involve up to 90 carefully selected, healthy adult volunteers being exposed to the virus in a safe and controlled environment. Researchers are encouraging people aged between 18 and 30 years old, who are at the lowest risk of complications resulting from coronavirus, to consider volunteering to take part.
Once the initial study has taken place, vaccine candidates, which have proven to be safe in clinical trials, could be given to small numbers of volunteers who are then exposed to Covid-19, helping to identify the most effective vaccines and accelerate their development.
Our final stop is the Science Media Centre where a number of experts have weighed in on the decision.
FEBRUARY 17, 2021
expert reaction to ethical approval for a virus characterisation study for COVID-19 to begin, as part of the Human Challenge Programme
It has been announced that the UK will be the first country in the world to run a COVID-19 human challenge study, following approval from the UK’s clinical trials ethics body.
This Roundup accompanied an SMC Briefing.
