RecruitingPHASE1INTERVENTIONAL

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

This research, called COVHIC003, aims to understand how a specific type of COVID-19, Omicron EG.5.1, affects healthy adults who have already been vaccinated. Volunteers, aged 18-50, will receive a small dose of the virus into their nose. The goal is to see how the infection develops and how their immune system reacts. This information will help develop new vaccines and treatments in the future. Participants will stay in a special quarantine unit for about 10-12 days, where they'll be closely checked. After leaving, they'll have follow-up appointments for six months. This study is funded by Imperial College London, the EU, and CEPI.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Imperial College London

Enrolment target

Start

10 Jul 2026

Estimated completion

31 Dec 2028

SARS-CoV-2 (COVID-19)

What is this study about?

This important study, known as COVHIC003, is trying to learn more about how a particular type of COVID-19, called Omicron EG.5.1, affects healthy adults who have previously had a COVID-19 vaccine. The researchers want to gently expose volunteers to the virus in a very controlled way to see how their bodies react and how their immune system fights off the infection. This is done by giving a small amount of the virus directly into the nose using drops.

The main goal is to create a safe and reliable way to study COVID-19 infection in people. By understanding how this specific Omicron variant behaves in vaccinated individuals, scientists can then use this knowledge to speed up the testing of new vaccines and treatments for future outbreaks. This type of research is really valuable because it helps us prepare better for new versions of the virus.

The study is taking place in special facilities in Oxford or London, and it's backed by Imperial College London, with funding from the European Union and CEPI, an organisation dedicated to preventing epidemics. It's a key part of wider efforts to protect people from infectious diseases.

Key takeaways

This study explores how a specific Omicron COVID-19 variant affects vaccinated people.
Healthy adults aged 18-50 will receive a small, controlled dose of the virus in their nose.
The aim is to develop better ways to test vaccines and treatments.
Participants will stay in a special quarantine unit for around 10-12 days.
Close medical monitoring and follow-up for six months are part of the study.
The study is backed by Imperial College London and international partners.

Who may be eligible?

To be considered for this study, you need to be a healthy adult aged between 18 and 50 years old. You must have had at least one COVID-19 vaccine jab, with your last dose being at least three months before you join the study. The team will also check your blood to confirm you've had COVID-19 before.

It's important that your immune system isn't too strong against the specific Omicron variant they are using in this study. This means they will check your antibody levels to make sure they are below a certain level. This helps them understand how the virus affects people with a specific level of existing immunity.

If you are a woman who could become pregnant, you'll need to agree to use effective contraception for a specific period during the study. All participants must be in good overall health, without any significant ongoing medical conditions that might make taking part unsafe. The study team will do thorough checks, including medical history, physical exams, and blood tests, to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 50 years old?
Have you had at least one COVID-19 vaccine, with the last dose over 3 months ago?
Are you generally in good health?
Are you willing to stay in a quarantine facility for about 10-12 days?
Are you able to attend follow-up appointments for 6 months?
If you are a woman of child-bearing potential, are you willing to use contraception as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have several checks to make sure you're suitable for the study. If you qualify, you'll be given a small amount of the SARS-CoV-2 Omicron EG.5.1 virus as drops in your nose. This is done with careful medical supervision.

After receiving the virus, you will stay in a special, safe quarantine unit for about 10 to 12 days. The exact length depends on whether you get infected and how quickly the virus clears from your system. During your stay, doctors and nurses will closely monitor your health. You'll have regular swabs (like nose or throat swabs), blood tests, and they'll ask you about any symptoms you might have.

Once you are well enough to leave the quarantine unit, the study isn't over. The research team will continue to follow up on your health for a further six months, with scheduled appointments to check your recovery and long-term well-being. This will involve further check-ups and tests. Throughout the entire study, if you receive a specific medication called Paxlovid, you'll need to follow instructions regarding sexual activity and contraception for a period after finishing the treatment.

Potential risks and benefits

Participating in this study could offer several benefits, as you would be contributing to important scientific knowledge that helps develop new ways to fight COVID-19. You'll receive free, comprehensive medical checks and close monitoring by experts throughout your time in the study. However, there are also potential risks, including the possibility of developing mild COVID-19 symptoms from the controlled infection, such as a cold, cough, or fever. You will be very closely monitored to ensure your safety and receive appropriate care if you do develop symptoms. It's important to remember that participating is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Royal Free London Nhs Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting
University of Oxford
Verified postcode
Oxford, United Kingdom· Not yet recruiting
University Hospital Southampton Nhs Foundation Trust
Verified postcode
Southampton, United Kingdom· Not yet recruiting

Common questions

What is a 'controlled human infection model'?

It's a way for scientists to study how a disease works by safely giving a small amount of a virus to healthy volunteers in a very controlled environment.

What type of COVID-19 will be used?

The study will use the SARS-CoV-2 Omicron EG.5.1 variant, which is one of the more recent forms of the virus.

Do I need to have had a COVID-19 vaccine to join?

Yes, all participants must have received at least one approved COVID-19 vaccine dose, with the last one at least three months ago.

Where will I stay during the study?

You will stay in a special quarantine unit, either in Oxford or at the Royal Free Hospital in London, for about 10-12 days.

What happens after I leave quarantine?

The study team will follow up on your health for six months after you are discharged from the quarantine unit.

How to find out more

Polly Fox-Sheehan, BSc, MSc

polly.fox@imperial.ac.uk +4420 3313 1282 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.