
COV009 Oxford Vaccine Study
Post-approval follow-up for the COV001 and 002 trials, to determine the long-term safety and character of immunological response to the ChAdOx1 nCoV-19 coronavirus vaccine

Project Details
Start Date
October 2021
End Date
December 2022
Status
Ongoing
Principal Investigator
Dr Rebecca K Sutherland
Main Research Site
WGH
COV009 is a non-interventional, observational study that aims to characterise the ongoing immunogenicity and safety profile of the Oxford/AstraZeneca COVID-19 vaccine (Vaxevria). It is open to anyone who took part in the COV002 trial which was the original phase II/III trial of the vaccine, the results of which led to the approval of the vaccine and its subsequent delivery to billions of people around the world.
This primary aims of this study are to:
- document the long-term safety profile of ChAdOx1 nCoV-19 vaccine,
- evaluate the character and durability of immune responses that are stimulated by ChAdOx1 nCoV-19 vaccine
The follow up of trial participants will provide earlier information on common adverse events since they were exposed to the vaccines before the global roll out. Currently, long-term experience of COVID-19 vaccine safety and efficacy, within clinical trials, is limited to 12 months post-vaccination. In addition, the quality and durability of the immune response that is stimulated has yet to be characterised beyond that period.
Here in Lothian, Dr Rebecca Sutherland is the local Principal Investigator and the study is being coordinated by the research team at the Regional Infectious Diseases Unit at the Western General Hospital, Edinburgh.
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