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. 2022 Jun 28;12(6):e054336.
doi: 10.1136/bmjopen-2021-054336.

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

Sarah Wallace  1 , Victoria Hall  2 , Andre Charlett  3 , Peter D Kirwan  1   4 , Michele Cole  1 , Natalie Gillson  1 , Ana Atti  1 , Jean Timeyin  1 , Sarah Foulkes  1 , Andrew Taylor-Kerr  1 , Nick Andrews  3 , Madhumita Shrotri  1 , Sakib Rokadiya  1 , Blanche Oguti  1 , Amoolya Vusirikala  1 , Jasmin Islam  1 , Maria Zambon  1 , Tim J G Brooks  1 , Mary Ramsay  1 , Colin S Brown  1 , Meera Chand  1 , Susan Hopkins  1
Affiliations

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

Sarah Wallace et al. BMJ Open. .

Abstract

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.

Keywords: COVID-19; IMMUNOLOGY; INFECTIOUS DISEASES.

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Conflict of interest statement

Competing interests: MZ has unremunerated positions as ISIRV Chair, Member of NERVTAG, SAGE and JCVI and codirector NIHR HPRU, Imperial College London. TB receives funding from the UKRI for the SIREN study. MR’s team in the UKHSA Immunisation Department provides vaccine manufacturers (including Pfizer) with postmarketing surveillance reports about pneumococcal and meningococcal disease which the companies are required to submit to the UK Licensing authority in compliance with their Risk Management Strategy. A cost recovery charge is made for these reports. Other authors have no competing interests to declare.

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