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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.

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.

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.