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Randomised trial to evaluate vaccine effectiveness for the UK COVID-19 immunisation programme

 

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*This document is to be used as a guide and to assist with completion of the online application form only. Please do not try to use this as an application form. You must apply using the online form in the Research Management System, available when calls are open.

For queries relating to this call, please contact ccf-nCoV@nihr.ac.uk.

The NIHR invites proposals for a rapidly implementable single randomised clinical trial to develop greater understanding of the UK’s COVID-19 vaccination programme, which is currently deploying Pfizer/BioNTech and University of Oxford/AstraZeneca vaccines. 

The UK has authorised several COVID-19 vaccines and initiated an ongoing population immunisation roll out, currently using the Pfizer/BioNTech and University of Oxford/AstraZeneca vaccines. Evaluation of vaccine effectiveness and programme effectiveness is ongoing via important studies. 

This funding call seeks bids from academic groups to undertake a randomised study in the UK to support scientific evaluation of the UK’s immunisation programme against clinical (as opposed to immunological) endpoints and inform future international policy development.

The intention is to fund one study that is rapidly implementable and streamlined, with a focus on clinical outcomes, especially infections and hospitalisation, and using electronic datasets where possible. 

The trial should evaluate first-to-second dose intervals of 28 and 84 days and must be capable of evaluating the long term effectiveness of the different dosing intervals and the effectiveness in the interval between first and second doses. Follow up for at least 12 months is required.

The UK programme is likely to evolve to deploy other vaccines in the future, including the possibility of revaccination in Autumn 2021; therefore, applicants must demonstrate an adaptive approach.

The successful applicant will need to work closely with, and be highly responsive to the needs of, the Department of Health and Social Care.

Any clinical trial proposed must dovetail with the UK’s ongoing vaccination programme and must not interfere with the execution of the programme, with demonstration of relevant discussions with NHS England essential as part of any proposal. Any trial must not delay the first dose of vaccine for Joint Committee on Vaccination and Immunisation priority groups 1-9, in terms of delayed timing or diversion of limited vaccine supplies.

Applicants should demonstrate the ability to commence the study by 1 April 2021.

All applicants are required to submit an Expression of Interest form ahead of submitting a full application. This form must be submitted by 17 February 2021.

The "Apply Now" button will lead you to the application form. 

The deadline for applying to this call is 13:00 on 24 February 2021.