The purpose of this study is to test the effectiveness of a vaccine against COVID-19 in healthy adult volunteers. The vaccine has been developed at the Jenner Institute at the University of Oxford.
The trial will also give us valuable information on safety aspects of the vaccine and its ability to generate strong immune responses against the virus.
We will randomly allocate participants to receive the new ChAdOx1 nCoV-19 vaccine or an existing meningitis vaccine (MenACWY) in addition to doing blood tests and collecting information about any symptoms that occur after vaccination.
To enrol in the trial, you must be aged 18 or over.
You must be in good health. Having a health problem does not automatically exclude you, but you cannot participate if you have any of the following conditions:
· Immunosuppression or deficient immunity for example HIV infection, absence of a functioning spleen, recurrent severe infections or use of immunosuppressant drugs for more than 14 days in the last six months
· Hereditary angioedema or idiopathic angioedema
· Any history of anaphylactic reaction or severe allergies
· If you have any form of cancer (except basal cell carcinoma of the skin)
· A serious mental health problem that might affect your ability to participate
· Bleeding disorders or use of anticoagulants like warfarin
· If you drink more than 42 units of alcohol per week
· If you have used intravenous drugs in the last 5 years
· If you have had laboratory confirmed COVID-19 infection
· New onset of fever, cough or shortness of breath since February 2020
You must NOT be pregnant, breastfeeding or planning a pregnancy. Women of childbearing age will need to agree to use contraception throughout the study period and take a urine pregnancy test on the day of vaccination.
You must NOT be participating in another clinical trial at the moment.
You must NOT have received a vaccine in the last 30 days or be planning to receive a vaccine in the 30 days following your trial vaccination.
You must NOT have received a blood transfusion or any blood products including immunoglobulins within the three months preceding your trial vaccination and must agree to refrain from blood donation during the course of the study.
You must work in an environment where you are at high risk of exposure to COVID-19 infection. This includes, but is not limited to, those who work in contact with patients on COVID-19 wards or units: especially nurses; doctors; physiotherapists; clinical support workers and assistants; receptionists; housekeepers; cleaners; patient escorts/porters. Outside of hospital, health care workers in primary care, paramedics, care home workers and carers of people with COVID-19 are also eligible.
You must read the Patient Information Sheet and complete the pre-screening questionnaire both of which are available on the main study website (click on the link at the end of this section)
Please follow the link to the Nottingham Site.
When you have completed the questionnaire, a member of our team will contact you to arrange your screening appointment.
Here you will be given some more information about the trial and have an opportunity to ask any questions you may have about it.
Then you will see a doctor who will confirm your eligibility and take your consent to participate.
You will then have some blood tests, one of which will be a test to see if you already have antibodies to the virus that causes COVID-19 in your blood. IF YOUR BLOOD IS POSITIVE FOR THESE ANTIBODIES, WE WILL CONTACT YOU BEFORE YOUR VACCINATION BECAUSE YOU WILL NOT BE ABLE TO PARTICIPATE IN THE STUDY.
You will be given an appointment for your vaccination a few days after your screening appointment.
You will need to attend the health centre for some follow up blood tests at one month, three months, and six months
If at any time you develop a fever, cough or breathlessness suggestive of COVID-19 you should let us know straight away and a member of the research team here will arrange to see you to take a throat swab and a blood sample.
You may also be asked to submit saliva samples to detect asymptomatic infection.