SARS-CoV-2 (COVID-19)
Conditions
Brief 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.
Interventions
BIOLOGICALSARS-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.
BIOLOGICALSARS-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
BIOLOGICALSARS-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
Imperial College London
Imperial College Healthcare NHS Trust
University College, London
University of Oxford
Royal Free Hospital NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Oxford University Hospitals NHS Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Dose Escalation/Expansion design
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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 * In good health with no history of clinically significant medical conditions (as described in
Exclusion criteria
) that would interfere with participant safety, as defined by medical history, physical examination and routine laboratory tests, ECG, and Chest X-Ray and determined by the Investigator at an admission evaluation * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and human clinical response to intranasal challenge of SARS-CoV-2 EG.5.1 variant in healthy participants who are immunologically experienced against SARS-CoV-2. | 28 Days | To evaluate the safety of Omicron variant SARS-CoV-2 challenge in healthy participants, by assessing: • Occurrence of AEs within 28 days post-viral challenge (Day 0 to Day 28) |
| Selection of the SARS-CoV-2 Omicron EG.5.1 dose(s) required to induce laboratory confirmed upper respiratory tract infection in 50-70% of immunologically experienced, healthy participants following intranasal challenge | 10 Days | Laboratory confirmed infection is defined as: two quantifiable (≥LLOQ) RT-PCR measurements from mid turbinate or throat samples, reported on 2 or more consecutive timepoints, starting from Day 2 (inclusive) post-inoculation and up to discharge from quarantine (Day 8 for uninfected participants or Day 10 for infected participants) |
Countries
United Kingdom
Contacts
CONTACTPolly Fox-Sheehan, BSc, MSc
PRINCIPAL_INVESTIGATORChristopher Chiu, BMBCh FRCP FRCPath PhD
Imperial College London
Outcome results
None listed