EMIS Recruit Immunosuppressed AEI Feasibility Study
Research type
Research Study
Full title
Enhanced Safety Surveillance of COVID-19 and Seasonal Influenza Vaccination using a Direct-to-Patient, Digital Adverse Drug Reaction (DADR) Reporting Form: Feasibility Study
IRAS ID
319822
Contact name
Meredith Leston
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
There is currently little awareness as to whether immunosuppressed patients experience side effects post-vaccination in the same way as those with normally functioning immune systems. For example, there is a need to understand whether the types of these side effects differ between these groups or even between different kinds of immunosuppressed patients. Current methods of pharmacovigilance (vaccine safety surveillance) including the Yellow Card reporting system and the analysis of computerised medical records (CMRs) may not be suited to collecting such detailed information, especially when it comes to milder side effects.
In partnership with the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), EMIS Health, PeopleWith and the UK Health Security Agency (UKHSA), the present study will test the feasibility of distributing a digital survey on vaccine side effects direct-to-patients in the 10-day window after they have received their latest COVID-19 or seasonal influenza vaccine. It will explore whether this Digital Adverse Drug Reaction (DADR) reporting form captures more information about vaccine side effects than existing vaccine safety surveillance methods – especially milder symptoms - and whether it might offer a future means of detecting different patterns in adverse events of interest (AEI) data between the immunosuppressed and those with immune systems that work normally.
7 practices will be recruited into the experimental condition. Patients from these practices that are 1) over the age of 18 and 2) have received a dose of a vaccine against COVID-19 or seasonal influenza in the last 10 days will be receive the DADR reporting form to enhance practices’ CMR-based vaccine safety surveillance. 7 practices will serve as matched controls to this experimental group. In this condition, patients will not receive the DADR reporting form and researchers will only be able to obtain vaccine safety information from CMRs.
REC name
London - Brent Research Ethics Committee
REC reference
23/PR/0891
Date of REC Opinion
13 Sep 2023
REC opinion
Favourable Opinion