Adapting COVID-19 research infrastructure to capture Influenza and Respiratory Syncytial Virus alongside SARS-CoV-2 in UK healthcare workers Winter 2022/23 and beyond: protocol for a pragmatic sub-study

Introduction During the COVID-19 pandemic, extensive research was conducted on SARS-CoV-2, however important questions about other respiratory pathogens remain unanswered. A severe influenza season in 2022-2023 with simultaneous circulation of SARS-CoV2 and Respiratory Syncytial Virus (RSV) is anticipated. This sub-study aims to determine the incidence and impact of these respiratory viruses on healthcare workers (HCW), the symptoms they experienced, the effectiveness of both COVID-19 and influenza vaccination and the burden of these infections on the National Health Service (NHS) workforce. Methods and analysis This is a longitudinal prospective cohort sub-study, utilising the population and infrastructure of SIREN, which focuses on hospital staff in the UK. Participants undergo fortnightly Nucleic Acid Amplification Testing (NAAT) on a multiplex assay including SARS-CoV-2, Influenza A&B and RSV, regardless of symptoms. Questionnaires are completed every two weeks, capturing symptoms, sick days, exposures, and vaccination records. Serum samples are collected monthly or quarterly from participants associated with a SIREN site. This sub-study commenced on 28/11/22 to align with the predicted influenza season and participants’ influenza vaccine status. The SIREN Participant Involvement Panel (PIP) shaped the aims and methods for the study, highlighting its acceptability. UK Devolved Administrations were supported to develop local protocols. Analysis plans include incidence of asymptomatic and symptomatic infection, comparisons of vaccination coverage; assessment of sick day burden, and effectiveness of seasonal influenza against infection and time off work. Data are also integrated into UKHSA nosocomial modelling. Ethics and dissemination The protocol was approved by the Berkshire Research Ethics Committee (IRAS ID 284460, REC Reference 20SC0230) on 14/11/2022. Participants were informed in advance. As the frequency and method of sampling remained the same, implied consent processes were approved by the committee. Participants returning to the study give informed consent. Regular reports to advisory groups and peer-reviewed publications are planned to disseminate findings and inform decision making. Trial registration number: [ISRCTN11041050][1]. Strengths and limitations of this study ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was funded by the UKHSA, Public Health Wales, Public Health Scotland, Public Health Agency Northern Ireland, and a grant from HDR-UK. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Berkshire Research Ethics Committee (IRAS ID 284460, REC Reference 20SC0230) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN11041050