COVHIC003: Development of a Controlled Human Infection Model for assessment of SARS-CoV-2 Omicron subvariants (COVHIC003)

Research summary

COVHIC003 is a controlled human infection study in which healthy adults aged 18-50 previously vaccinated with a COVID-19 vaccine will be administered a SARS-CoV-2 Omicron subvariant given by drops in the nose. The aim is to achieve breakthrough upper-respiratory infection in a proportion of volunteers with mild or no illness, providing information on the course of Omicron infection and the immune response in vaccinated people. This study will establish an optimised challenge dose and model using a recent Omicron strain that can then be used to evaluate new vaccines and treatments in follow-on trials. Participants will stay in a quarantine unit for approximately 11–13 days, depending on infection status, and will be closely monitored with regular swabs, blood tests and symptom assessments throughout their stay. They will be followed up by the study team for 6 months after being discharged. This study is sponsored by Imperial College London and forms part of the MUSICC project which is led by Imperial College London and co-funded by the European Union’s Horizon Europe Programme and the Coalition for Epidemic Preparedness Innovations (CEPI). Inpatient quarantine will take place at specialist facilities in Oxford or at the Royal Free Hospital in London. Pre-screening and screening will take place at Imperial College NHS Trust, Southampton NHS Trust, University of Oxford/NHS Trust, and Guys & St Thomas' Foundation Trust. Follow-up visits will occur at all sites except Guys & St Thomas' and Royal Free Hospital.

Principal Investigator

Prof Helen McShane

Contact us

Email: vaccinetrials@ndm.ox.ac.uk

IRAS number

362560