Impact of prior SARS-CoV-2 infection and COVID-19 vaccination on the subsequent incidence of COVID-19: a multicentre prospective cohort study among UK healthcare workers – the SIREN (Sarscov2 Immunity & REinfection EvaluatioN) study protocol
Nick Andrews,
Mary Ramsay,
Maria Zambon,
Victoria Hall,
Sarah Wallace,
Susan Hopkins,
Jean Timeyin,
Tim J G Brooks,
Amoolya Vusirikala,
Meera Chand,
Andre Charlett,
Sakib Rokadiya,
Colin S Brown,
Madhumita Shrotri,
Peter D Kirwan,
Michele Cole,
Natalie Gillson,
Ana Atti,
Sarah Foulkes,
Andrew Taylor-Kerr,
Blanche Oguti,
Jasmin Islam
Affiliations
Nick Andrews
London School of Hygiene and Tropical Medicine, National Institute for Health and Care Research (NIHR) Health Protection Research Unit in Vaccines and Immunisation, London, UK
Mary Ramsay
Immunisation and Vaccine Preventable Diseases, UK Health Security Agency, London, UK
Maria Zambon
National Infection Service, UK Health Security Agency, London, UK
Victoria Hall
National Infection Service, UK Health Security Agency, London, UK
Sarah Wallace
National Infection Service, UK Health Security Agency, London, UK
Susan Hopkins
UK Health Security Agency, London, UK
Jean Timeyin
National Infection Service, UK Health Security Agency, London, UK
Tim J G Brooks
National Infection Service, UK Health Security Agency, London, UK
Amoolya Vusirikala
National Infection Service, UK Health Security Agency, London, UK
Meera Chand
National Infection Service, UK Health Security Agency, London, UK
Andre Charlett
UK Health Security Agency, London, UK
Sakib Rokadiya
National Infection Service, UK Health Security Agency, London, UK
Colin S Brown
National Infection Service, UK Health Security Agency, London, UK
Madhumita Shrotri
National Infection Service, UK Health Security Agency, London, UK
Peter D Kirwan
National Infection Service, UK Health Security Agency, London, UK
Michele Cole
National Infection Service, UK Health Security Agency, London, UK
Natalie Gillson
National Infection Service, UK Health Security Agency, London, UK
Ana Atti
National Infection Service, UK Health Security Agency, London, UK
Sarah Foulkes
National Infection Service, UK Health Security Agency, London, UK
Andrew Taylor-Kerr
National Infection Service, UK Health Security Agency, London, UK
Blanche Oguti
National Infection Service, UK Health Security Agency, London, UK
Jasmin Islam
National Infection Service, UK Health Security Agency, London, UK
Introduction Understanding the effectiveness and durability of protection against SARS-CoV-2 infection conferred by previous infection and COVID-19 is essential to inform ongoing management of the pandemic. This study aims to determine whether prior SARS-CoV-2 infection or COVID-19 vaccination in healthcare workers protects against future infection.Methods and analysis This is a prospective cohort study design in staff members working in hospitals in the UK. At enrolment, participants are allocated into cohorts, positive or naïve, dependent on their prior SARS-CoV-2 infection status, as measured by standardised SARS-CoV-2 antibody testing on all baseline serum samples and previous SARS-CoV-2 test results. Participants undergo monthly antibody testing and fortnightly viral RNA testing during follow-up and based on these results may move between cohorts. Any results from testing undertaken for other reasons (eg, symptoms, contact tracing) or prior to study entry will also be captured. Individuals complete enrolment and fortnightly questionnaires on exposures, symptoms and vaccination. Follow-up is 12 months from study entry, with an option to extend follow-up to 24 months.The primary outcome of interest is infection with SARS-CoV-2 after previous SARS-CoV-2 infection or COVID-19 vaccination during the study period. Secondary outcomes include incidence and prevalence (both RNA and antibody) of SARS-CoV-2, viral genomics, viral culture, symptom history and antibody/neutralising antibody titres.Ethics and dissemination The study was approved by the Berkshire Research Ethics Committee, Health Research Authority (IRAS ID 284460, REC reference 20/SC/0230) on 22 May 2020; the vaccine amendment was approved on 12 January 2021. Participants gave informed consent before taking part in the study.Regular reports to national and international expert advisory groups and peer-reviewed publications ensure timely dissemination of findings to inform decision making.Trial registration number ISRCTN11041050.
