Trial NCT04400838
Publication Emary K, Lancet, 2021
Dates: 2020-05-31 to 2020-11-13
Funding: Mixed (UK Research and Innovation, Engineering and Physical Sciences Research Council, Coalition for Epidemic Preparedness Innovations, NIHR, Medical Research Council and Wellcome Trust Core Award. )
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / UK Follow-up duration (months): 4.93 | |
| • ChAdOx1 (n=5600) • Control (n = 5211) |
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| Inclusion criteria | Adults aged 18 years and older;participants in occupations with potentially high SARS-CoV-2 exposure, such as those in health and social care settings; Able and willing (in the Investigator’s opinion) to comply with all study requirements; 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; For females of childbearing potential only, willingness to practice continuous effective contraception 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. |
| Exclusion criteria | Participation in COVID-19 prophylactic drug trials for the duration of the study; Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study; 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; 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); 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, 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); History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY; Any history of angioedema; Any history of anaphylaxis; Pregnancy, lactation or willingness/intention to become pregnant during the study; Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ); History of serious psychiatric condition likely to affect participation in the study; Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture; Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban); Suspected or known current alcohol or drug dependency; Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data; Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed) |
| Interventions | |
| Intervention
2 IM doses (5 x 10^10 vp) ChAdOx1 nCoV-19 vaccine on Days 0/28 2 IM doses of MenACWY control vaccine on Days 0/28 |
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| Control
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| Participants | |
| Randomized 10673 participants | |
| Characteristics of participants Type of participants: People in close contact with COVID-19 patients N=10673 1992 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
| Description of participants Adults seronegative at baseline enrolled at 19 study sites in UK | |
| Primary outcome | |
| In the register 1.Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older. [ Time Frame: Study duration (12 months from last vaccination) ] Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19 2.Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults [ Time Frame: Study duration (12 months from last vaccination) ] Occurrence of serious adverse events (SAEs) throughout the study duration. | |
| In the report Symptomatic COVID-19 disease, defined as a positive NAAT result on an upper airway swab in a participant with at least one symptom, including cough, fever of 37·8°C or higher, shortness of breath, anosmia, or ageusia. | |
| Variants description | |
Variants
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| Description Variant name: Alpha Direct evidence Method: Post-hoc analysis Missing outcome results: 122 cases (45%)with no sequence data (arm not reported) | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, When the trial is complete, upon request directed to the corresponding author. All data will be made available for a minimum of 5 years from the end of the trial. |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Variant alpha: Some concerns |
| General comment | * |