Hello and thank you for your interest in taking part in the COVID-19 vaccine trial.
Your involvement in this trial is vital so that we can test COVID-19 vaccinations,
to ensure that the vaccine is safe and provides immunity from disease. We hope that this video
will give you an overview of what is involved and expected of you as a volunteer in the trial.
Multiple vaccine trials are taking place across the UK. The principles of each trial will be the
same, but there might be slight variation depending on the individual trial site.
There are four elements that we will cover in this video.
Safety procedures, arrival and registration, during the trial visit and after the vaccination visit.
Safety
The safety and well-being of everybody involved in the vaccine trial is of utmost importance.
If you have any concerns, our expert team of healthcare professionals are on hand
to support you before, during and after the trial, so please talk to them.
During your visit to the site, please adhere to social distancing procedures.
You must wear a face mask unless you're exempt.
and please use the hand sanitizing gel provided. On arrival to the site you will be asked to have your
temperature taken and undertake a COVID-19 symptom check. This is to ensure that anyone with suspected
COVID-19 symptoms do not enter the building. If you think you have COVID-19 symptoms at the
time of your visit, please do not attend and we ask that if you cannot attend please let us know.
Arrival & Registration
Prior to your visit you'll be sent a patient information sheet that contains detailed
information about the vaccine study. This also includes where it will take place, where to park
and the accessibility of the site. If you require additional assistance during the
trial please contact your local delivery team, so they can support you. We want everybody that's
eligible to be able to take part in this vital research. When you arrive at the site a member
of our team will welcome you and you'll be shown to a socially distanced waiting area.
During the trial visit - Consent and screening
The first thing we need to do is to obtain your official consent to take part in the trial.
This means that you'll be asked to read a document that explains everything that's involved in the trial,
including why we are doing the trial, what you will have to do, the benefits of taking part and
any potential risks that may be involved. If you are unsure of any of the information, healthcare
professionals will be available to answer your questions. If after reading the document
you don't feel comfortable taking part in the trial, you can withdraw your consent at any time.
Medical Assessment
If you give consent to take part, a doctor will complete a medical assessment to check
if you're well enough to take part in the study. This is decided by the use of eligibility criteria.
If you're taking medication please bring a prescription showing which ones.
You are not required to bring the drugs themselves. The process of obtaining your consent and
completing the medical assessment will take approximately one to two hours. You may then
be asked to receive a vaccination, but if not then your next trial visit will be discussed with you.
The Vaccination
Randomisation is a process that decides whether you receive the actual vaccine
trial drug or a placebo. A placebo is not an actual drug and is used as a control in testing new drugs,
so that the research team cannot tell which group you are in. You will not know which option you have
been given. A nurse will give you a dose of the vaccination or a placebo by injection.
They will also do a blood test and throat or nose swab. This process will take around 10 to 15 minutes
and wearing a short sleeve top will help the nurse get better access to your arm.
Observation
Before you go home we want to ensure that you are feeling well, so we will ask you to wait in a
socially distanced observation area for 30 minutes. Your well-being is important, so if you feel unwell
or if you have any questions please let our team know and they will be able to support you.
The amount of time people are observed may alter a little after vaccination.
After this 30 minute observation period and all is ok, you'll be safe to leave and travel home.
You'll be provided with a helpline number that you can call if you become unwell or if you need support
between visits. Your next appointment will be confirmed whilst at your first vaccination visit.
After the vaccination visit
After your trial visit, please continue to follow the government's coronavirus guidance.
Some trials require checks to see if you have COVID-19 and will ask you to
complete an electronic diary of symptoms and some may issue home swap tests.
If this is the case, you'll be provided with the training and how to use them.
We're here to help you
If you have any questions, are running late for your appointment,
can't attend your appointment or want to speak to our team at any time, please call the number
on the patient information sheet that has been sent to you. We'd like to thank you
for your time and for considering taking part in these very important COVID-19 vaccine trials