25 March 2021
The UK’s COVID-19 human challenge study has reached its first milestone after administering virus to three volunteers in a controlled clinical setting at the Royal Free Hospital.
Participants were inoculated with a low dose of COVID-19, introduced via droplets in the nose, and carefully monitored by clinical staff in a controlled environment over a two-week period. The team reports no complications, confirming the participants are in good health.
The first participants recruited to the landmark trial have now completed a period of quarantine. They will now continue to be monitored by the clinical team.
The team is unable to discuss any further details of the study at this early stage, such as symptoms. It is essential to keep the outcomes confidential to maintain the scientific integrity of the study. To protect volunteers’ privacy and wellbeing, the team will continue to preserve volunteers’ anonymity.
The researchers will now move to the next stage of the trial, recruiting further healthy volunteers aged 18-30 to establish the lowest possible dose of virus needed to cause viral replication in the upper respiratory tract.
Caroline Clarke, group chief executive of the Royal Free London, said: “We are incredibly proud to be working with our partners from hVIVO, Imperial College London and the government’s Vaccine Taskforce on this important research. We’re delighted that the first stage of the study has been completed successfully and we look forward to continuing our close collaboration as this research moves forward.”
Dr Chris Chiu, Chief Investigator and Reader in Infectious Disease at Imperial College London said: “We’re pleased to confirm the first group of three healthy volunteers has now successfully completed the first stage of the trial, with no unexpected issues. It would be premature to discuss further details at this early stage.”
Professor Peter Openshaw, co-investigator on the study and Professor of Experimental Medicine at Imperial College London, said: “This is vital research to understand the course of disease in those with mild infections and to investigate the detailed natural history of this infection. Once this investigational human challenge model is established, we will be able to go on to test vaccine efficacy, immune defense and the benefits of new medicines that become available in the future. We are very pleased and reassured that the study has gone well in this first group of volunteers.”
Dr Andrew Catchpole, Chief Scientific Officer at hVIVO, part of Open Orphan plc said: “We would like to thank these volunteers for their participation in this important study and look forward to welcoming the following cohorts. We expect that this study will greatly assist our understanding of this disease and provide insights into its progression, natural immune response, and transmission. We look forward to publishing the study’s results in due course and moving forward with vaccine challenge studies later this year.”
The Human Challenge Programme is a partnership between Imperial College London, the Department for Business, Energy and Industrial Strategy (BEIS) and Department of Health and Social Care (DHSC), hVIVO, a leading clinical company with expertise in viral human challenge models, and the Royal Free London NHS Foundation Trust.