A phase III randomized controlled trial to determine safety, efficacy, and immunogenicity of the non-replicating ChAdOx1 nCoV-19 vaccine

niversity of Oxford0 sites10,300 target enrollmentJune 11, 2020

ConditionsCOVID-19 (SARS-CoV-2 infection)Infections and Infestations

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: COVID-19 (SARS-CoV-2 infection)
Sponsor: niversity of Oxford
Enrollment: 10300
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/33306989/ interim results (added 09/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33617777/ results (added 23/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35779491/ exploratory analysis of responses in males and females (added 04/07/2022) Other publications in https://pubmed.ncbi.nlm.nih.gov/34615860/ post-hoc exploratory analysis of the vaccine against the SARS-CoV-2 lineages circulating (added 14/08/2024)

Registry

who.int

Start Date

June 11, 2020

End Date

March 31, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Oxford

Eligibility Criteria

Inclusion Criteria

•Current inclusion criteria as of 25/11/2020:
•1\. Adults aged 18 to 55 years of age
•2\. Adults aged 56\-69 years old (after review of safety data by DSMB in this age group in the UK trial)
•3\. Adults aged 70 and above years old (after review of safety data by DSMB in this age group in the UK trial)
•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/personal doctor and access all medical records when relevant to study procedures
•4\. 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
•5\. Agreement to refrain from blood donation during the course of the study
•6\. Provide written informed consent
•7\. Health professionals and/or adults at high risk of exposure to SARS\-CoV\-2

Exclusion Criteria

•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 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 accidentally unblind participants to group allocation. Participation in COV003 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
•3\. Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 30 days before and after study vaccination
•4\. 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)
•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; asplenia; recurrent severe infections and chronic use (more than 14 days) 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 or paracetamol
•8\. Any history of angioedema
•9\. Any history of anaphylaxis
•10\. Pregnancy, lactation or willingness/intention to become pregnant during the study