COVHIC003: Controlled Human Infection Study
COVHIC003: Controlled Human Infection Study
Development of a Controlled Human Infection Model for assessment of SARS-CoV-2 Omicron subvariants
Recruiting Now!
We are looking for healthy volunteers aged 18 – 50 years old to take part in a new Coronavirus Controlled Human Infection Study.
The study involves a pre-screening visit, a screening visit, an up to 13-day quarantine stay at during which you will be deliberately infected with the COVID-19 virus and carefully monitored until discharge, followed by four follow-up visits over the course of 6 months.
If you are eligible to take part, you will be paid up to £3,935 for time and inconvenience.
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The COVHIC003 study part of a global consortium project called The Mucosal Immunity in Human Coronavirus Challenge (MUSICC). It 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) and is laying the crucial groundwork needed to understand the role of immunity in the respiratory tract and develop the next generation of vaccines.
As part of the MUSICC project, Imperial, in collaboration with Imperial College London, Oxford University, Royal Free Hospital and University College London, Southampton Clinical Research Facility and Guy’s and St Thomas’ Hospital, London, are conducting a new controlled human infection study (also known as a human challenge study) with SARS-CoV-2, the coronavirus that causes COVID-19.
For more information on MUSICC, please visit www.musicc.org
What is the purpose of this study and why participate?
SARS-CoV-2 is the virus responsible for causing COVID-19 disease and led to the COVID-19 global pandemic. There are a number of licensed vaccines for COVID-19 now, and while they are effective at preventing severe disease and death, we don’t fully understand why some people who are vaccinated can still get infected, sometimes with little or no symptoms, and therefore continue to spread the virus to others.
We would like to develop a safe, controlled human infection model (challenge model) where volunteers who have been vaccinated against COVID-19 are deliberately given the Omicron EG.5.1 subvariant of SARS-CoV-2 virus. We will gather information from this study that will enable future research that may help us understand what kind of immune response stops people from being infected with SARS-CoV-2 and the impact of the virus on the immune system. This may eventually help with the development of improved COVID-19 vaccines that could reduce the transmission of virus.
To do this, we need to establish a dose of virus required to cause infection in around 50-70% of people (defined by positive throat and nose swabs) but with the aim of causing minimal or no symptoms. For safety purposes, we will have very strict selection criteria for who can take part and will perform close monitoring of participants (including an inpatient quarantine stay).
In this study, healthy adult volunteers, aged 18 to 50 years (inclusive), who have been vaccinated against COVID-19, will be deliberately infected with the Omicron EG.5.1-strain of the COVID-19 virus so that researchers can learn more about the infection and test new vaccines and treatments in the future.
What the does study involve?
The study will consist of three phases; a Screening phase, a Quarantine phase and a Follow-up phase.
Screening phase
To begin with, researchers will conduct an initial pre-screening visit to look at your antibodies against SARS-CoV-2. For this study, in order for us to meet our study aim and achieve infections in at least half or our participants, your antibodies need to be below a certain threshold. This is because we know that those with much higher antibodies are very unlikely to become infected. Only around 20% of the participants who come to pre-screening will have low enough antibodies to progress further.
If you meet the antibody level criteria, you will be invited to a screening visit. Participants will have the opportunity to discuss the study in full with the research team and have their questions answered before signing a consent form. The study team will then perform a number of screening eligibility assessments to see if they would meet the eligibility criteria for the study.
Quarantine phase
If eligible after screening, you may then be invited to the quarantine phase of the study. The quarantine phase will take place in a dedicated quarantine unit in London or Oxford so the virus cannot be passed on to people outside the study. Participants will be admitted to the quarantine unit two days prior to being deliberately exposed to the SARS-CoV-2 virus and will have to stay in their allocated quarantine room for 11-13 days (in total) for observation as well as sample and data collection for the purposes of research and safety monitoring. The duration of stay will depend on whether participants become infected with SARS-CoV-2, in which case they will stay for 10 days after exposure, or if they remain uninfected
Follow-up phase
After discharge from quarantine, participants will attend four scheduled follow up visits on Day 14, Day 28, Day 90 and Day 180 at one of the study sites.
If you are interested in finding out more, please read the full study information sheet.
Am I eligible to participate?
As part of this study, participants will be given SARS-CoV-2 virus (the cause of COVID-19 disease) as drops in the nose. Therefore, they might get a COVID-19 infection and develop
COVID-19 symptoms, such as tiredness, cough, fever and (uncommonly) loss of smell and/or taste. We do not want to give the virus to anyone at an increased risk of becoming more seriously unwell and therefore, we have a strict eligibility criterion to minimise the risks to anyone taking part.
Key eligibility criteria:
- You must be 18-50 years old (inclusive) at the time of consent.
- You must be willing and able to commit to the study procedures and visits
- You must have had at least one dose of a COVID-19 vaccine.
- You must be in good health with no clinically significant medical conditions.
- You must weigh at least 45kg and have a BMI between 18 and 30 (use the NHS BMI Calculator).
- You must have knowledge of your family’s significant medical history.
- You must NOT be in close domestic contact (e.g. live with) anyone under 2 years old or over 65 years old or anyone who is clinically vulnerable or immunosuppressed.
- You must NOT have severe allergies or intolerances, for example, to foods or drugs, that cause severe allergic reactions such as anaphylaxis.
- You must NOT be a current active smoker (including the use of e-cigarettes).
“Current active” means around 5 or more cigarettes a week.
- You must NOT take drugs through the nasal or inhaled routes (including recreational drugs).
- You must NOT consume more than 28 units of alcohol per week (one unit being a half glass of beer, a small glass of wine or a measure of spirits).
You must NOT have a history of, or currently active, clinically significant illness. Examples include:
- Cancer (except basal cell carcinoma)
- Cardiovascular diseases such as high blood pressure, stroke and heart failure
- Respiratory diseases such as asthma, COPD and cystic fibrosis
- Bleeding or clotting disorders
- Diabetes (Type 1 or 2)
- Liver or kidney disease
- Rheumatoid arthritis
- Epilepsy
- Any immunodeficiency or autoimmune disease
- Significant depression or anxiety.
- You must NOT have a family history of a first-degree relative aged 50 years or less with sudden cardiac or unexplained death.
- You must NOT have personal or a family history of unexpectedly severe COVID-19 (i.e. requiring hospitalisation) or a family history of clotting disorders.
If you are a person of child-bearing potential:
- You must NOT be currently pregnant.
- You must NOT be planning to get pregnant within 6 months of receiving the study virus.
- You must be willing to use effective contraception, such as the pill, an IUD (the coil), the implant or injection, or you must use condoms, or you must practice abstinence with a heterosexual partner until 6 months after receiving the study virus. This does not apply if you or your partner are sterile.
- You must NOT have been pregnant in the last 6 months.
- You must NOT have been breastfeeding in the last 6 months.
- You must NOT donate any human egg (oocyte) for at least 6 months are being given the study virus.
The Study Sites
Not all the study sites have a quarantine unit for the quarantine phase so you may need to transfer to another site for the quarantine phase.
At Oxford , we conduct the screening, quarantine and follow up phase of the study. For information on how to travel to Experimental Medicine Clinical Research Facility (EMCRF), University of Oxford, please see map below:
Experimental Medicine Clinical Research Facility (EMCRF), University of Oxford
The screening, quarantine and follow up phases all take place at the Oxford study site.
Address: Oxford Experimental Medicine Clinical Research Facility, Churchill Hospital, Headington, Oxford OX3 7LE
Royal Free Hospital, London
The quarantine phase will take place at the Royal Free study site.
Address: Royal Free Hospital, Pond St, London NW3 2QG
NIHR Imperial Clinical Research Facility, London
The screening and follow up phases only take place at the Imperial Clinical Research Facility (ICRF). Participants who are screened at this site and are eligible to proceed will be transferred to a quarantine in Oxford or the Royal Free Hospital, London.
Address: NIHR Imperial Clinical Research Facility Imperial Centre for Translational and Experimental Medicine Imperial College Healthcare NHS Trust Hammersmith Hospital Campus, Du Cane Rd, London W12 0HS
NIHR Southampton Clinical Research Facility, Southampton
The screening and follow up phases only take place at the Southampton Imperial Clinical Research Facility. Participants who are screened at this site and are eligible to proceed will be transferred to a quarantine in Oxford or the Royal Free Hospital, London.
Address: South Central Regional Research Delivery Network (Southampton office)
Guy’s and St Thomas’ Hospital, London
The screening phase only will take place at the Guy’s and St Thomas’ Hospital in London. Participants who are screened at this site and are eligible to proceed will be transferred to a quarantine in Oxford or the Royal Free Hospital, London and can then have their follow up visits at the Imperial Clinical Research Facility.
Address: Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, Westminster Bridge Rd, London SE1 7EH
Upcoming Quarantines
|
Quarantine Number and Location(s) |
Admission Date |
Challenge Date |
Discharge Date |
Status |
|
TBC |
TBC |
TBC |
TBC |
TBC
|
|
TBC |
TBC |
TBC |
TBC |
TBC
|
Please note: if you remain uninfected, you will have the option to leave the quarantine unit at Day 8, instead of Day 10 post-challenge (2 days earlier than the discharge dates in the table above). You may be able to stay in the quarantine unit until Day 10 if agreed in advance with the study team. Otherwise, you will be required to return on Day 9 and Day 10 for follow up visits. You may be able to do this back at your original screening site, if applicable and if agreed in advance.
There will be additional travel reimbursements if you are travelling to a quarantine site that was not the site you were screened at.
Table 4. Travel expense limits for journeys to and from quarantine
You must provide receipts for all journeys you wish to claim for with no exceptions. If you do not have receipts, you will not be able to be reimbursed for your journey(s). You must travel in standard classes only (not First Class).
If you choose to leave quarantine on Day 8 as an uninfected participant and return to that quarantine site for the Day 9 and Day 10 visits, you will not be additionally reimbursed for travelling to those visits as well. You can only claim for one journey into quarantine and one journey out of quarantine. The outpatient Day 9 and 10 visits, and all the follow up visits do not allow for reimbursement for travel.
Ethical and Safety Considerations
Ethics
Review by an ethics committee is one of a series of safeguards intended to protect people taking part in all clinical research studies. It is a thorough process and there are many principles that are considered during the review, including weighing up the benefits against the risks. Another important consideration is making sure the potential participants receive high-quality, comprehensive information about the study in a timely fashion. The information about this controlled human infection study sent to and discussed with potential volunteers is very detailed and there are measures in place to make sure it is understood, so potential volunteers have a full picture of what the risks are and what the study entails before agreeing to take part (this is known as informed consent).
You can find out more about Research Ethics Committees (RECs) and the Health Research Authority (HRA) approvals on the HRA website. A REC is made up of experts from different backgrounds (for example doctors, clinical trial experts, and scientists) and members of the public.
This study received ethical approval to commence on Tuesday 7th July 2026 by the Oxford A Research Ethics Committee.
Safety
No clinical study is completely risk-free, but the researchers who design and conduct controlled human infection studies have done everything possible to minimise the risks to the volunteers who take part, the study staff, and the wider community. The research teams also ensure that potential volunteers are fully informed about the risks before agreeing to take par during the process of informed consent.
SARS-CoV-2 is still causing disease ranging from asymptomatic (no symptoms) or mild illness to severe respiratory disease that can also affect other parts of the body in large numbers of people throughout the world. Humans have only experienced infections with this virus since late 2019 and the full range of symptoms or diseases caused by COVID-19 is still being investigated. Therefore, at present it is not possible to fully predict all potential risks to you from participating in this study, including long term risks.
Some people when infected with COVID-19 experience no symptoms at all. More severe cases of COVID-19 disease are usually seen in the elderly (over 65 years of age) and those with pre-existing medical conditions (such as diabetes). Although the risks of hospitalisation and death are thought to be very low in healthy adults, the factors that might increase the risk of such events are not completely known and therefore may not be detected in the screening process prior to entering the study.
The participants allowed to join the study are at the lowest risk of becoming severely unwell with COVID-19; they are vaccinated against COVID-19 and in good health, verified by a number of screening safety tests and assessments and a thorough review of their medical history. During the study, participants might get common symptoms of COVID-19 (including fever, tiredness, a cough, and changes to taste/smell), but these are expected to be mild and of short duration (1-2 weeks).
There is a small risk that participants could of the volunteers getting long COVID, with more prolonged symptoms that can last for months. Some of the common symptoms reported are loss of smell/taste, tiredness and brain fog. Participants will be monitored for 6 months after being exposed to the virus.
Severe disease or death due to COVID-19 in this population is very uncommon, but there is still a small risk. However, the risk to participants in the study becoming seriously unwell or dying is relatively lower, because they are screened for underlying health conditions and other factors that increase the chances of severe disease.
There are also other measures in place during the study to minimise these risks, including giving the volunteers the smallest amount of virus needed for infection and close monitoring for early signs of more serious symptoms.
If any of the volunteers show any concerning symptoms, they will be moved from the quarantine unit where the study is taking place into the main hospital where the specialist critical care of infectious disease would take over their care.
News and Relevant Publications
Contact Us
To get in touch with the study team, please email: Covid19-challenge@paediatrics.ox.ac.uk.
What do I do if I want to take part?
If you are interested in taking part in this study, please ensure you have read the full Participant Information Sheet.
If after reading this you would like to take part, please complete the below pre-screening questionnaire.Please try to answer all questions openly and honestly to the best of your ability.
Please note: by completing this survey, you are registering at the University of Oxford. If you would like to register at a different site, please follow this link to the study locations where you can then find the websites for the other study sites.
All information we obtain will be used in accordance with our privacy policy.
For further information about this questionnaire or any aspect of the study, please contact: Covid19-challenge@paediatrics.ox.ac.uk.
If you are interested in taking part, please click here to apply via the pre-screening questionnaire