Safety & immunogenicity extension study for ChAdOx1 nCoV-19 [COVID-19]
Research type
Research Study
Full title
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
IRAS ID
300456
Contact name
N/A CTRG
Contact email
Sponsor organisation
Clinical Trials and Research Governance (CTRG), University of Oxford
Eudract number
2021-003382-36
ISRCTN Number
ISRCTN16270186
Duration of Study in the UK
1 years, 7 months, 5 days
Research summary
On the 29th December 2020 the UK regulator MHRA authorised the Oxford/AstraZeneca ChAdOx1 nCOV-19 vaccine for emergency use.
The first participant received ChAdOx1 nCoV-19 on 23rd April 2020, so there is limited long-term data following human exposure to this novel vaccine. Since 2012, several hundred patients have received different ChAdOx-based vaccines to prevent other diseases, including influenza, tuberculosis, prostate cancer and malaria, where to date, no serious adverse events were considered related to those vaccines. Under the “conditions of authorisation for emergency supply” in the UK and other territories, AstraZeneca agreed to meet the demands of a pharmacovigilance risk management plan, to provide ongoing monitoring of individuals who have received the vaccine.
This Safety & Immunogenicity Extension Study aims partly to fulfil those obligations, while also gathering data to permit investigation into the character and persistence of the immune responses that have been stimulated. As such, this is an observational study, where we do not propose to administer additional medicines. Risk to participants is limited to those resulting from simple phlebotomy at the two study visits. The findings that result from COV009 will be valuable to vaccine developers and policymakers, to inform decisions on future vaccine scheduling and design.
This trial (COV009 trial) will follow-up participants previously enrolled on the UK phase I/II (COV001) and phase II/III (COV002) trialsREC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0261
Date of REC Opinion
20 Aug 2021
REC opinion
Further Information Favourable Opinion