A phase I/II study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers

niversity of Oxford0 sites1,077 target enrollmentApril 6, 2020

Overview

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32702298/ preliminary results (added 20/07/2020) 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)

Registry

who.int

Start Date

April 6, 2020

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 22/04/2020:
•1\. Healthy adults aged 18\-55 years
•2\. Able and willing (in the Investigator’s opinion) to comply with all study requirements (participants must not rely on public transport or taxis)
•3\. 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
•4\. For females 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
•5\. Agreement to refrain from blood donation during the course of the study
•6\. Provide written informed consent
•\_\_\_\_\_\_
•Previous inclusion criteria:
•1\. Healthy adults aged 18 \- 55 years

•Current exclusion criteria as of 30/10/2020:
•1\. Prior receipt of any vaccines (licensed or investigational) \=30 days before enrolment
•2\. Planned receipt of any vaccine 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 vaccine. Participants will be encouraged to receive these vaccinations at least 7 days before or after their study vaccine.
•3\. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines)
•4\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
•5\. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; 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)
•6\. Any autoimmune conditions, except mild psoriasis, well\-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy
•7\. History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV\-19 or MenACWY vaccines.
•8\. Any history of angioedema
•9\. Any history of anaphylaxis