A phase I/II trial of a candidate COVID-19 vaccine (COV001)
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
Sponsor: University of Oxford
CI: Prof Andrew Pollard
Approval Date: 11 March 2020
Researchers at University of Oxford are 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 COVID-19) 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.
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. 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 vaccine or a placebo injection in addition to doing blood tests and collecting information about any symptoms that occur after vaccination. The study would enrol up to 510 healthy adults, aged 18 - 55 years of age living near to a study site in the UK. Dependent on the group, there will be between five and nine study visits over a 12 month period. Participants will be asked to complete a diary for 7 days after the vaccination and will be closely monitored by the study team.
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