COVID-19 Vaccine Intranasal Study (COV008)
COVID-19 Vaccine Intranasal Study (COV008)
What is the purpose of this trial?
The purpose of this study is to test a new route of administration for the Oxford/AstraZeneca COVID vaccine in healthy volunteers aged 18-55 years (30-55 years for groups 4 and 5). Intranasal administration may improve protection against infection and transmission, and has the advantage of not requiring a needle. Intranasal administration may also be useful for administering a booster dose to individuals doubly vaccinated intramuscularly.
The trial will give us valuable information on the safety of the vaccine and extent of the immune response when administered intranasally in healthy volunteers. We do this by giving participants the vaccine via a nasal spray, in addition to doing blood tests, nasal swabs, and collecting information about any symptoms that occur after vaccination. Participants in groups 1-3 will be randomly allocated to receive either one or two doses of the vaccine, whilst participants in groups 4 and 5, those doubly vaccinated prior to enrolment, will all receive one dose of the vaccine
Am I eligible to participate?
For groups 1-3 only:
For groups 4 and 5 only:
What does the trial involve?
Screening visit: at your pre-enrolment screening visit, we will answer any questions you might have about this study followed by taking your consent to participate if you are happy to do so. After you have consented, we will do a medical history check, a physical exam and take safety bloods to determine your eligibility.
Enrolment: You will be allocated to one of five groups, depending on availability and your vaccination status, and will receive the IN ChAdOx1 nCov-19 vaccine. The groups are: Group 1 (lower dose), group 2 (higher dose), group 3 (intermediate dose), group 4 (two previous ‘Oxford/AZ’ doses) and group 5 (two previous ‘Pfizer’ doses). If you are enrolled in groups 1-3, you will be randomised to have either one or two doses of the vaccine. You can see the visit schedules for both below. If you are in group 1a or 2a, you will have an extra visit at D3 post first vaccination.
Follow up visits and symptom tracking: You will be asked to fill in an electronic diary card to tell us about any symptoms you have after vaccination and will be required to have blood and nasal swabs taken at most of the follow-up visits.
Visit Schedule for SINGLE DOSE groups:
Visit Schedule for TWO-DOSE groups:
Is there any reimbursement for the trial?
Yes, you will be reimbursed at set rates for your time, inconvenience and travel which for this study will be approximately £325-370 for all participant receiving one dose and £445-490 for participants receiving two doses. For full details of the reimbursement provided, read the participant information sheet.
What are the advantages of taking part?
By taking part, you will make an important contribution to knowledge which may aid in the development of a new route of administration for a COVID-19 vaccine. This route may allow for easier vaccine administration without needles and be more effective in blocking COVID-19 spread. Such knowledge would improve the health and economic situation of millions of people.
You will also be able to get information about your general health during the pre-enrolment process.
Are there any risks from taking part in the study?
We do not expect the side effects to be significantly different from numerous trials we have conducted using this and similar vaccines, however, this will be the first time this vaccine has been given to humans via the intranasal route. Please refer to the trial information sheet for full details of procedures and potential risks.
What will happen if I don’t want to carry on with the study?
Participation is voluntary and you are free to change your mind and withdraw at any time. This will not affect your subsequent medical care in any way. If you withdraw we might need to offer you a follow up visit, for example to check the vaccination site or a blood result. Your compensation would be paid as a proportion of the total compensation according to the length of your participation.
For more details about the study, please read the full participant information sheet.