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

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

UK Health Security Agency

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11 Citations (Scopus)

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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.

Original language	English
Article number	054336
Journal	BMJ Open
Volume	12
Issue number	6
DOIs	https://doi.org/10.1136/bmjopen-2021-054336
Publication status	Published - 28 Jun 2022

Bibliographical note

Funding Information: This work was supported by the Department of Health and Social Care and UK Health Security Agency (formerly Public Health England), with contributions from the Scottish, Welsh and Northern Irish governments.
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.

Open Access: This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Citation: Wallace S, Hall V, Charlett A, et al. 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. BMJ Open 2022;12:e054336. doi: 10.1136/bmjopen-2021-054336

DOI: 10.1136/bmjopen-2021-054336

Keywords

COVID-19
IMMUNOLOGY
INFECTIOUS DISEASES

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Wallace, S., Hall, V., Charlett, A., Kirwan, P. D., Cole, M., Gillson, N., Atti, A., Timeyin, J., Foulkes, S., Taylor-Kerr, A., Andrews, N., Shrotri, M., Rokadiya, S., Oguti, B., Vusirikala, A., Islam, J., Zambon, M., Brooks, T. J. G., Ramsay, M., ... Hopkins, S. (2022). 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. BMJ Open, 12(6), Article 054336. https://doi.org/10.1136/bmjopen-2021-054336

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title = "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",

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 na{\"i}ve, 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",

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

note = "Funding Information: This work was supported by the Department of Health and Social Care and UK Health Security Agency (formerly Public Health England), with contributions from the Scottish, Welsh and Northern Irish governments. 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{\textquoteright}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. Open Access: This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Citation: Wallace S, Hall V, Charlett A, et al. 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. BMJ Open 2022;12:e054336. doi: 10.1136/bmjopen-2021-054336 DOI: 10.1136/bmjopen-2021-054336 ",

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Wallace, S, Hall, V , Charlett, A , Kirwan, PD , Cole, M, Gillson, N, Atti, A, Timeyin, J, Foulkes, S, Taylor-Kerr, A, Andrews, N, Shrotri, M, Rokadiya, S, Oguti, B, Vusirikala, A, Islam, J , Zambon, M , Brooks, TJG , Ramsay, M , Brown, CS , Chand, M & Hopkins, S 2022, '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', BMJ Open, vol. 12, no. 6, 054336. https://doi.org/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. / Wallace, Sarah; Hall, Victoria ; Charlett, Andre et al.
In: BMJ Open, Vol. 12, No. 6, 054336, 28.06.2022.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Impact of prior SARS-CoV-2 infection and COVID-19 vaccination on the subsequent incidence of COVID-19

T2 - A multicentre prospective cohort study among UK healthcare workers-the SIREN (Sarscov2 Immunity & REinfection EvaluatioN) study protocol

AU - Wallace, Sarah

AU - Hall, Victoria

AU - Charlett, Andre

AU - Kirwan, Peter D.

AU - Cole, Michele

AU - Gillson, Natalie

AU - Atti, Ana

AU - Timeyin, Jean

AU - Foulkes, Sarah

AU - Taylor-Kerr, Andrew

AU - Andrews, Nick

AU - Shrotri, Madhumita

AU - Rokadiya, Sakib

AU - Oguti, Blanche

AU - Vusirikala, Amoolya

AU - Islam, Jasmin

AU - Zambon, Maria

AU - Brooks, Tim J.G.

AU - Ramsay, Mary

AU - Brown, Colin S.

AU - Chand, Meera

AU - Hopkins, Susan

N1 - Funding Information: This work was supported by the Department of Health and Social Care and UK Health Security Agency (formerly Public Health England), with contributions from the Scottish, Welsh and Northern Irish governments. 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. Open Access: This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Citation: Wallace S, Hall V, Charlett A, et al. 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. BMJ Open 2022;12:e054336. doi: 10.1136/bmjopen-2021-054336 DOI: 10.1136/bmjopen-2021-054336

PY - 2022/6/28

Y1 - 2022/6/28

N2 - 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.

AB - 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.

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KW - IMMUNOLOGY

KW - INFECTIOUS DISEASES

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JO - BMJ Open

JF - BMJ Open

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Wallace S, Hall V , Charlett A , Kirwan PD , Cole M, Gillson N et al. 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. BMJ Open. 2022 Jun 28;12(6):054336. 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

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

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