The world’s first COVID-19 human challenge study is set to begin in the UK within the next few weeks after receiving ethics approval, the government has announced.
The study has already received a £33.6m investment from the UK government, and will initially involve up to 90 healthy adult volunteers who will be exposed to the novel coronavirus in a safe and controlled environment.
In this first stage of the study, researchers will aim to discover the smallest amount of the virus it takes to cause COVID-19 infection in small groups of healthy young people aged between 18-30 years old who are at a low risk of harm.
This stage – known as the virus characterisation study – will initially use the version of the SARS-CoV-2 virus that has been circulating in the UK since the beginning of the pandemic in March 2020.
The version of the virus used in this stage of the study has been produced by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, in collaboration with clinical company hVIVO and with support from virologists at Imperial College London.
Following this, researchers will give a small number of volunteers vaccine candidates – which have already been proven safe in clinical trials – and will then expose them to COVID-19.
This will help researchers to identify the most effective vaccines and accelerate their development, the government said.
“We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for COVID-19,” said Clive Dix, interim chair of the UK’s Vaccines Taskforce.
“We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection,” he added.
The COVID-19 human challenge study is part of a partnership between the UK’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and hVIVO.
Human challenge studies have been used previously to support the development of treatments for a range of disease, including malaria, typhoid, cholera, norovirus and influenza.
Researchers involved in the COVID-19 human challenge study are asking for people aged 18 to 30 years old, who are at low risk of developing complications from coronavirus, to volunteer for the study.
“We are asking for volunteers aged between 18 and 30 to join this research endeavour and help us to understand how the virus infects people and how it passes so successfully between us,” said Chris Chiu, chief investigator of the study.
“Our eventual aim is to establish which vaccines and treatments work best in beating this disease, but we need volunteers to support us in this work,” he added.