Post-approval follow-up study for the COV001 and COV002 trials to determine the long-term safety and character of immune response to the Oxford-AstraZeneca coronavirus vaccine
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN16270186
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1077
1. Participated in the COV001 - Phase I/II or COV002 - Phase II/III trials
2. Able and willing to provide written, informed consent to participate in the study
3. Able and willing (in the investigator’s opinion), to comply with all study requirements
4. Consent to general practitioner or responsible physician being notified of participation in the study
5. Consent to allow investigators to discuss their medical information with their general practitioner (GP) or responsible physician, and to access any medical records where relevant to the study
6. Consent to access NHS SARS-CoV-2 NAAT results, including viral sequencing, results from NHS Digital and local sequencing labs, as well as COVID-19 vaccination records if available
1. Participants who have enrolled on a clinical trial of an investigational medicinal product (CTIMP) for a novel COVID-19 vaccine will be excluded. Examples would include the COV-Variant or ComCOV trials
2. Participants who fail to enrol onto COV009 within 26 weeks of their last study visit on the parent study will be excluded. If consent is not obtained within 26 days from the last visit on the parent trial, the participant will become ineligible for COV009
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ong-term safety of the ChAdOx1 nCoV-19 vaccine measured from the registry of serious adverse events (SAEs) and adverse events of special interest (AESIs) at visit 1 (6 months, +/- 28 days) and visit 2 (12 months, +/- 28 days) and may also be reported by the participant at other times during the study
- Secondary Outcome Measures
Name Time Method Character and durability of the immune response to vaccination measured by the immune responses (for a subset of participants, in exploratory immunology group), anti-SARS-CoV-2 spike protein immunoglobulins, and neutralising antibodies against SARS-CoV-2 at visit 1 (6 months +/- 28 days) and visit 2 (12 months +/-28 days)