UK receives ethics approval for first coronavirus human challenge study

The UK has received approval from the clinical trials ethics body for the world’s first coronavirus human challenge study

Having received approval from the clinical trials ethics body, the UK will start the world’s first COVID-19 human challenge study in a months time to support vaccine and treatment development.

Researchers are calling on healthy young people aged between 18-30 years to volunteer for the study to improve knowledge of how the virus affects people and help doctors understand how the immune system reacts to coronavirus and identify factors that influence how the virus is transmitted.

Up to 90 volunteers will be exposed to a small amount of the original version of the virus, which 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, in a safe and controlled environment and will be monitored 24 hours a day.

NHS

The team is also working closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not impact the NHS and the study will not begin without their go-ahead.

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.”

The 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. It has also been backed by a £33.6 million UK government investment.

Interim Chair of the Vaccines Taskforce Clive Dix 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. 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.”

Chief Investigator Dr Chris Chiu, from Imperial College London, said:

“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. 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.”

Chief Scientific Officer at hVIVO, Dr Andrew Catchpole said:

“Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the COVID-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic.

“This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required. Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.”

To register interest in taking part in this study visit https://ukcovidchallenge.com/