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.
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
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
Sequential
SARS-CoV-2 Omicron EG.5.1 challenge agent 10^5 TCID50
Biological/Vaccine10\^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.
SARS-CoV-2 Omicron EG.5.1 challenge agent 10^6 TCID50
Biological/Vaccine10\^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
SARS-CoV-2 Omicron EG.5.1 challenge agent 10^4 TCID50
Biological/Vaccine10\^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
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.
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)
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.
To evaluate the safety of Omicron variant SARS-CoV-2 challenge in healthy participants, by assessing: • • Occurrence of SAEs related to the viral challenge (Day 0 to Day 180)
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
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)
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborator
University College, London
Collaborator
University of Oxford
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
University Hospital Southampton NHS Foundation Trust
Collaborator
Oxford University Hospitals NHS Trust
Collaborator
