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

You may not qualify if:

• 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
• Any significant abnormality altering the anatomy or function of the nose or nasopharynx in a substantial way (including loss of or alterations in smell or taste), a clinically significant history of epistaxis (large nosebleeds) within the last 3 months, nasal or sinus surgery within 6 months of inoculation
• History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the Investigator
• Significant history or presence of drug or alcohol misuse (exceeding \>28 units a week)
• Current use of any drugs taken through the nasal or inhaled route including recreational drugs
• Psychiatric illness including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis.
• Current active smokers, equivalent to \>5 cigarettes per week, including use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch) or electronic cigarettes. • Participants who have smoked ≥5 pack years at any time \[5 pack years is equivalent to one pack of 20 cigarettes a day for 5 years\]) or the equivalent amount of nicotine if using alternative forms. • Ex-smokers who have smoked \<5 pack years at any time must not of have regularly smoked in the last 3 months equivalent to \>5 cigarettes per week.
• Family history of 1st degree relative aged 50 years or less with sudden cardiac or unexplained death
• Personal or Family History of unexpectedly severe COVID-19, adverse response to any other viral disease e.g. Guillain-Barré, or a family history (described as a 1st degree relative) with clotting disorders
• A total body weight of ≤ 45kg and a Body Mass Index (BMI) ≤18 kg/m2 and ≥28 kg/m2. The upper limit of BMI may be increased to ≤ 30kg/m2 at the Investigator's discretion, in the case of physically fit muscular individual
• Venous access deemed inadequate for the phlebotomy demands of the study.
• Any clinically significant abnormal finding on screening biochemistry, haematology and microbiology blood tests or urinalysis i.e. grade 1 lab abnormalities or above apart from minor deviations which are clinically acceptable and approved by the Investigator
• +28 more criteria