Safety & immunogenicity extension study for ChAdOx1 nCoV-19

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.

Closed to recruitment

Aims of the study

We are asking volunteers to continue for another year in this follow up study. There is limited information about the long-term side effects of the vaccine, and we would like to continue to study how the immune system responds after vaccination.

Eligibility criteria

  • Enrolled in COV001 or COV002 trials
  • Able and willing to provide written informed consent to participate in the study.
  • Able and willing (in the investigator’s opinion) to comply with all study requirements.
  • Consent to their general practitioner or responsible physician being notified of their participation in the study.
  • Consent to allow investigators to discuss their medical information with their general practitioner or responsible physician and access any medical records where relevant to the study.
  • Consent to access NHS SARS-CoV-2 NAAT results including viral sequencing results from NHS Digital and local labs, as well as COVID-19 vaccination records if available.

What participating in the study involves

Should you decide to take part, we would enrol you to this study at the final visit for COV001 or COV002. If this has already happened, we will arrange for you to come to the clinic to sign a consent form and enrol in this study. All visits should take no longer than 30 minutes.

There will be blood tests taken at two further visits at 6 months and 12 months post consent. For the majority of people this would be 10ml at each visit. For a small number of participants in each age group (18-55 years, 56-69 years, or 70 years and over) and COV002 Group 12 participants, up to 50ml of blood would be taken to explore immune responses in more detail.
At each visit we will ask you about any new medical diagnosis or serious illness you may have experienced and any vaccination you have received. We will also collect information about COVID-19 diagnosis and check if you are taking part in any other clinical trials