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 - A phase I/II trial of a candidate COVID-19 vaccine (COV001)

niversity of Oxford0 sites1,112 target enrollmentMarch 19, 2020

ConditionsCOVID-19 MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsNimenrix Menveo

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19
Sponsor: niversity of Oxford
Enrollment: 1112
Status: Active, Not Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 19, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity of Oxford

Eligibility Criteria

Inclusion Criteria

•Healthy adults aged 18\-55 years.
•Able and willing (in the Investigator’s opinion) to comply with all study requirements (participants must not rely on public transport or taxis).
•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.
•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.
•Agreement to refrain from blood donation during the course of the study.
•Provide written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 1112

Exclusion Criteria

•Prior receipt of any vaccines (licensed or investigational) \=30 days before enrolment
•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.
•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).
•Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
•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) .
•Any autoimmune conditions, except mild psoriasis, well\-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy.
•History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV\-19 or MenACWY vaccines.
•Any history of angioedema .
•Any history of anaphylaxis .
•Pregnancy, lactation or willingness/intention to become pregnant during the study.