Why are we doing this research?
The purpose of this research is to look at the effects of infecting healthy participants with SARS-CoV-2 (COVID-19 or the “study virus”) – including immune responses in the blood and lining of their noses, before, during and after viral infection (administering the virus). This is called a COVID-19 human challenge model.
The information obtained from this study will allow us to better understand the human biological response to the COVID-19 infection (for example, to see if an initial episode of mild COVID-19 illness stimulates immunity (protection) against a future challenge (infection) and to learn why some people get sick and others do not/why some people have more and/or worse symptoms than other) as well as to test new vaccines developed to prevent COVID-19.
Who will participate in this study?
Up to 120 healthy volunteers who are:
- aged between 18 to 30 years of age
- vaccinated against COVID-19
- healthy with no underlying medical conditions
What will the study involve?
The study will consist of three phases; a Screening phase, a Quarantine phase and a Follow-up phase.
Screening phase
Screening will take place at the Oxford Experimental Medicine Clinical Research Facility (EMCRF)/ Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). Participants will have the opportunity to discuss the study with the research team and have their questions answered before signing a consent form. The study team will then collect data and samples from them to see if they would meet the eligibility criteria for the study.
Quarantine phase
If the screening phase suggests that they are suitable for the study, we may then invite them to the quarantine unit at the Oxford EMCRF where they will be given the study virus and requested to stay in their allocated quarantine room for 13-17 days for observation and to prevent the spread of infection.
Follow-up phase
After discharge from quarantine, they will have a follow-up phone call at Day 21 from the study team to check on their well-being and they will be requested to attend a scheduled clinic visit on Days 28, 90, 180, 270 and 360 back at the Oxford EMCRF/ CCVTM.
What is the duration of this study?
Each participant will be in the study for approximately 12 months from screening to their last scheduled visit.
Are there any potential benefits?
Taking part in the study is unlikely to provide health benefits but participants might develop some immunity to the study virus and benefit from a general health check at screening. They will be paid for their time if they take part (up to £4,470).
What should I do if I want to take part?
If you decide you want to take part, you should read the full Participant Information Sheet and then complete the pre-screening questionnaire.