A phase I/II study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers.
Closed to recruitment – in follow up.
Aim of Study:
To assess efficacy of the candidate ChAdOx1 nCoV-19 vaccine against COVID-19. 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.
Inclusion criteria:
Be aged 18-55 years old Be in good health
Exclusion criteria:
You must not be pregnant, intending to become pregnant, or breastfeeding during the study. You must not have previously taken part in a trial with an adenoviral vaccine or received any other coronavirus vaccines and also not have tested positive for COVID-19.
What participating in the study involves?
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.