NCT07397455

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-02-09
• Last updated: 2026-02-09