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Development of a Controlled Human Infection Model for Assessment of SARS-CoV-2 Omicron Subvariants | Clinical Trials | Clareo Health

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

NCT07397455•Imperial College London

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The study informed consent form has been signed and dated by the participant and the Investigator
•Adults age between 18 and 50 years inclusive (at the time of enrolment)
•Evidence of having had at least one COVID-19 vaccine, with the last vaccination at least 3 months before enrolment
•Positive serology for SARS-CoV-2 at (pre)screening
•Sero-suitable as defined by having serum and/or nasal antibody titres less than a pre-defined cut-off of a defined assay(s) which will be specified in a separate SOP and based on accumulating antibody data
•People of child-bearing potential (POCBP) must be willing and able to use contraception as described in the study protocol from 2 weeks before the scheduled date of viral challenge until the end discharge from quarantine.
•Negative urine pregnancy tests will be required at screening and on day 0 prior to inoculation. On admission to the quarantine unit a negative serum beta human chorionic gonadotropin (β-hCG) is required
•Male participants who are willing to use one of the contraception methods described in the study protocol, from the time of the date of viral challenge until the end of quarantine
•Agree to abstain from sexual activity or use effective contraception from the start of treatment with Paxlovid until 7 days after completing treatment with Paxlovid should they receive it

Exclusion Criteria

•Participants will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening
•Willing to be registered with The Over-Volunteering Protection Service (TOPS)
•Willing and able to commit to participation in the study.
•History or evidence of any clinically significant or currently active cardiovascular, (including thromboembolic events), respiratory, dermatological, gastrointestinal, endocrine, haematological, hepatic, immunological, rheumatological, metabolic, urological, renal, neurological, psychiatric illness
•Any significant abnormality altering the anatomy or function of the nose or nasopharynx in a substantial way (including loss of or alterations in smell or taste), a clinically significant history of epistaxis (large nosebleeds) within the last 3 months, nasal or sinus surgery within 6 months of inoculation
•Clinically-active, symptomatic rhinitis (including hay fever) or history of severe rhinitis, or seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine
•History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the Investigator
•Significant history or presence of drug or alcohol misuse (exceeding \>28 units a week)
•Current use of any drugs taken through the nasal or inhaled route including recreational drugs
•Psychiatric illness including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis.
+34 more criteria

Key Dates

Start Date

June 1, 2026

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

February 9, 2026

Enrollment

ESTIMATED participants

Conditions

SARS-CoV-2 (COVID-19)

Interventions

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

Contacts

Polly Fox-Sheehan, BSc, MSc

CONTACT

+4420 3313 1282 polly.fox@imperial.ac.uk