COVID-19 Vaccine Study

What is the purpose of this trial?

The purpose of this study is to test a new vaccine against COVID-19 in healthy volunteers.

A new virus causing respiratory disease emerged in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world, despite unprecedented containment efforts. The virus is part of the Coronavirus family which may cause respiratory infections ranging from the common cold to more severe diseases. This recently discovered coronavirus causes coronavirus disease COVID-19.

Common symptoms of COVID-19 include fever, tiredness, and dry cough. Whilst about 80% of infected people have only mild symptoms and will recover from the disease without needing special treatment, 1 in every 6 people who gets COVID-19 becomes seriously ill. Older people and those with underlying medical problems are more likely to develop serious illness. Thousands of deaths have been reported so far.

The WHO declared the COVID-19 epidemic a Public Health Emergency of International Concern on 30th January 2020. There are no currently licensed vaccines or specific treatments for COVID-19. Vaccines are the most cost effective way of controlling outbreaks and the international community have stepped-up their efforts towards developing one against COVID-19.

This study will enable us to assess if healthy people can be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus. We will do this by randomly allocating participants to receive the COVID-19 vaccine or a control injection in addition to doing blood tests and collecting information about any symptoms that occur after vaccination.

Condition Studied

COVID-19 Trial Length

6 months (with optional 1 visit at 1 year post vaccination) Number of visits

4-12 (depending on the group)

Am I eligible to participate?

You must: You must NOT: Be aged 18-55 years old Have tested positive for COVID-19 Be in good health Be pregnant, intending to become pregnant, or breastfeeding during the study Based in the Bristol area Have previously taken part in a trial with an adenoviral vaccine or received any other coronavirus vaccines

Bristol Area

Please note you will only be eligible if you are currently living in the BS1-6 and BS8 area in the first instance:

FAQs



What does the trial involve?

During this study, we will recruit a total of 1112 volunteers, of which up to 561 will be vaccinated with the candidate vaccine ChAdOx1 nCoV-19, and up to 551 will be vaccinated with a control vaccine. Volunteers will be blinded to what group they are in (except group three).

If you are in group 1, you will have 8 visits over a period of 6 months with an optional extra visit a year from the vaccination.

Group 2 volunteers will have 4 visits over a period of 6 months with an optional extra visit a year from the vaccination.

Group 3 volunteers will attend 11 visits over a period of 6 months, also with an optional extra visit a year from the first vaccination.

Group 4 volunteers will attend 4 visits over a period of 6 months, also with an optional extra visit a year from the first vaccination.

Vaccine appointments usually last around 90 minutes, and follow-up appointments around 20 minutes. Please note visits may take longer due to the high number of planned volunteers in the trial.

Is there any reimbursement for the trial?

You will receive compensation for your time, travel and contribution. If you participate in the study until the end, you will receive a total payment of £235.

What are the advantages of taking part?

Knowledge gained from this study will help us develop a vaccine against the newly emerging coronavirus disease COVID-19. There are no direct benefits of taking part, however you will receive a full medical examination at your screening appointment as part of the study.

Are there any risks from taking part in the study?

Although this is the first time this vaccine has been administered to humans, similar investigational vaccines have been widely administered for many pathologies without significant safety concerns.

The risks and side effects of the proposed study procedures are:

Blood samples: drawing blood may cause slight pain and occasionally bruising

Vaccinations: Common side effects are some mild redness and swelling at the injection site. You may feel like you have flu-like symptoms within 24 hours of the vaccinations. These usually resolve within 48 hours.

Please refer to the 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. You do not need to provide a reason. 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.

For more details about the study, please read the full information sheet :

Information sheet

You can make a difference.

If you think you are interested in this study, please complete our pre-screening questionnaire :

Pre-screening Questionnaire