What is the purpose of the study?

The purpose of this registry is to establish a list of healthy adult volunteers, 18 to 64 years of age, who may potentially be eligible for participation in influenza or other respiratory infection studies.  The registry will contain information about people and results from blood, nasal and oral tests done on their samples. The information will be used by investigators at Imperial College to screen and contact people who appear eligible for certain research studies. Depending on the results of your antibody measurements, you may be contacted in the future to discuss participation in a human infection challenge or vaccine study. Also, a small amount of extra blood, nasal and oral samples will be placed in a freezer to be used for new screening tests that have not yet been approved for use.

To participate in this registry, you must be willing to be contacted for potential recruitment into future influenza, or other respiratory infection or vaccine studies. The main purpose of the registry is to establish a list of healthy volunteers who may be recruited into future challenge and vaccine studies.

Should you agree to participate in this registry, you are not agreeing to be in any other specific research studies. If you are approached for participation in a human infection challenge or vaccine study at some point in the future, you will be free to decline and still remain in this registry.

What is involved?

Visit 1

The study involves a screening visit at the Imperial Clinical Research Facility which should take no longer than one hour. During this first visit, a member of the study team will discuss the study in detail with you and answer any questions you may have, ask you to sign a consent form. After this, we will undertake the following procedures:

• Obtain your demographic information including your age, sex, race.
• Obtain information to confirm whether you are eligible to participate in this registry, including alcohol use, that if you are female you are not pregnant or breastfeeding, that you have no significant medical issues, and any allergies you may have
• Review your medical history including vaccination history against influenza (the flu), SARS-CoV-2, as well as any influenza and/or respiratory illness due to SARS-CoV-2 in the past 12 months
• Review all medications that you have taken within the past 30 days
• Collect your vital signs including heart rate, respiratory rate, blood pressure and temperature
• Measure your height and weight
• Draw blood from you for research lab tests for serum antibodies (a substance that is in your blood that fights germs) (about 6.5 tablespoons) by a needle stick in your arm.

You will be paid £30 for attending the first visit, even if you are found not to be eligible.

For a subgroup of participants, we may collect additional nasal and oral samples. If the study team decide to offer you enrolment into this subgroup, then you will be paid £40 instead of £30. You will not be able to choose which group you go into but you can decline to take part in this subgroup.

 

Follow Up Visits (every 3 months)

The follow up visits should last approximately 30 minutes, during which we will:

• Review your eligibility
• Review your medical history including influenza vaccination history, vaccination history against SARS-CoV-2, as well as any influenza and/or respiratory illness due to SARS-CoV-2 since your last visit.
• Review all medications you have taken within the past 30 days
• Collect your vital signs including heart rate, respiratory rate, blood pressure and oral temperature
• Measure your weight
• Draw blood from you for research serum antibodies (about 6.5 tablespoons) by a needle stick in your arm
• For a subset of participants: collect nasal and oral samples

You will be paid £30 for attending each follow up visit

For the subgroup of participants having the additional nasal samples, they will be paid £40 for each follow up visit they attend.