Participate Southampton

COVID-19 Vaccine Study (COV002)

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 ChAdOx1 nCoV-19 vaccine or a Men ACWY vaccine in addition to doing blood tests, nasal/throat swabs and collecting information about COVID-19 related symptoms any other symptoms that occur after vaccination.

Condition Studied
COVID-19

Trial Length
12 months

Number of visits
6-12

(dependent on group)

Am I eligible to participate?

Recruitment of those with likely higher exposure to SARS-CoV-2 will be prioritised, in order to increase the likelihood of obtaining efficacy endpoints in the context of a waning epidemic. These priority groups will mainly consist of, but are not limited to, COVID-19 patient facing frontline healthcare workers (e.g. those working in ICU, A&E, COVID-19 wards, Paramedics, Care Homes, GP COVID-19 hubs, dentists, COVID-19 testing centres), non-healthcare staff working in COVID-19 clinical areas (e.g. hospital porters, receptionists, cleaners and others working in hospital environments), and other public facing keyworkers with no access to personal protective equipment, amongst others.

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

Please note you will only be eligible if you are currently living in Southampton and the surrounding areas highlighted below.

FAQs

What does the trial involve?

During this study, we will recruit up to 12,330 volunteers, of which up to 6,335 will be vaccinated with the candidate vaccine ChAdOx1 nCoV-19, and 5,995 will be vaccinated with a Men ACWY vaccine. Volunteers will be blinded to what group they are in.

If you are in group 1, 2, 7 or 8, you will have 9-12 visits over a period of 12 months, depending on the dose schedule.

Group 4,6, 9 and 10 volunteers will attend 6-8 visits over a period of 12-15 months.

Group 5 volunteers will attend 9-12 visits over a period of 12 months.

Group 11 volunteers will attend 8 visits over a period of 13 months.

*Please note, we have completed recruitment.*

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.

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.

Are there any risks from taking part in the study?

Although this is a new vaccine, 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.