ISRCTN90906759
Active, Not Recruiting
Phase 2
A phase II/III study to determine the efficacy, safety and immunogenicity of the candidate coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19 (SARS-CoV-2 infection)
- Sponsor
- niversity of Oxford
- Enrollment
- 12390
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33220855/ results (added 19/11/2020) 2021 Interim results article in https://doi.org/10.1016/S0140-6736(20)32661-1 interim results (added 09/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33617777/ results (added 23/02/2021) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34480858/ Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK (added 06/09/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35779491/ (added 04/07/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 04/12/2020 (see additional files for previous interventions):
- •1\. Adults aged 18\-55 years (groups 4, 5, 6 and 11\)
- •2\. Adults aged 56\-69 years (groups 1, 7 and 9\)
- •3\. Adults aged 70 years and older (groups 2, 8 and 10\)
- •4\. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •5\. Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures
- •6\. For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- •7\. Agreement to refrain from blood donation during the course of the study
- •8\. Provide written informed consent
- •Additional Inclusion criteria for Group 12 (HIV sub\-study):
Exclusion Criteria
- •Current exclusion criteria as of 21/10/2020 (see additional files for previous interventions):
- •1\. Participation in COVID\-19 prophylactic drug trials for the duration of the study
- •Note: Participation in COVID\-19 treatment trials is allowed in the event of hospitalisation due to COVID\-19\. The COV002 study team should be informed as soon as possible
- •2\. Participation in SARS\-CoV\-2 serological surveys where participants are informed of their serostatus for the duration of the study
- •Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
- •3\. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccination. Participants will be encouraged to receive these vaccinations at least 7 days before or after their study vaccine
- •4\. Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine.
- •5\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •6\. Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short\-term oral steroids (course lasting \=14 days)
- •7\. History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV\-19 or MenACWY
Outcomes
Primary Outcomes
Not specified
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