A phase I/II trial of a candidate COVID-19 vaccine (COV001) [COVID-19] [UPH]
Research type
Research Study
Full title
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
IRAS ID
281259
Contact name
Andrew J Pollard
Contact email
Sponsor organisation
University of Oxford
Eudract number
2020-001072-15
ISRCTN Number
ISRCTN15281137
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Researchers at University of Oxford are in the process of developing a coronavirus vaccine called ChAdOx1 nCoV-19. The vaccine acts by encouraging the immune system to recognise and attack the coronavirus. It is made from a harmless virus called an adenovirus that has been altered to produce the surface spike protein of COVID-19. The study will assess if healthy people can be protected from COVID-19 with this new vaccine. It will give information on the safety of the vaccine and how well it can create a good immune response against the virus. The first trials will be in younger adults, followed by people over 55 and, then larger trials in adults over 18 years, before studies in later school age children. In this trial over 1000 healthy adults, aged 18 – 55 years of age in the UK will be given either the coronavirus vaccine or a control vaccine (that cannot protect against COVID19) on a random basis. Participants will be asked to complete a diary for 7 days after the vaccination to provide information on how they feel. They will be closely monitored by the study team. They will be asked to return for blood tests between 5 and 9 times over a 12-month period and information will be collected about any symptoms that occur after vaccination. If the vaccine is shown to be safe and effective in these earlier trials, vaccine manufacturing will be increased to allow larger studies to take place.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0145
Date of REC Opinion
23 Mar 2020
REC opinion
Favourable Opinion