Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants

Summary

COVHIC003 is a human infection challenge study in which healthy adults aged 18-50 previously vaccinated with an approved COVID-19 vaccine will be administered a SARS-CoV-2 Omicron EG.5.1 variant 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 that can then be used to evaluate new vaccines and treatments in follow-on trials. Participants will stay in a quarantine unit for approximately 10-12 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). Quarantine will take place at specialist facilities in Oxford or at the Royal Free Hospital in London.

Conditions

• SARS-CoV-2 (COVID-19)

Interventions

BIOLOGICAL

SARS-CoV-2 Omicron EG.5.1 challenge agent 10^5 TCID50

10\^5 TCID50 This is a SARS-CoV-2 Omicron EG.5.1 challenge agent which has not been given in controlled human infection studies previously.

BIOLOGICAL

SARS-CoV-2 Omicron EG.5.1 challenge agent 10^6 TCID50

10\^6 TCID50 This is a SARS-CoV-2 Omicron EG.5.1 challenge agent which has not been given in controlled human infection studies previously

BIOLOGICAL

SARS-CoV-2 Omicron EG.5.1 challenge agent 10^4 TCID50

10\^4 TCID50 This is a SARS-CoV-2 Omicron EG.5.1 challenge agent which has not been given in controlled human infection studies previously

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• University College, London

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Christopher Chiu, BMBCh FRCP FRCPath PhD · Imperial College London

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-10

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• United Kingdom

Study Locations