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Protocol to measure COVID-19 XBB.1.5 vaccine effectiveness in the immunocompromised population during the 2023 autumn vaccination campaign

2025-12Relatório Acesso aberto
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dc.contributor.authorNunes, Baltazar
dc.contributor.authorHumphreys, James
dc.contributor.authorBlake, Alexandre
dc.contributor.authorSavulescu, Camelia
dc.contributor.authorKissling, Esther
dc.contributor.authorNardone, Anthony
dc.contributor.authorMonge Corella, Susana
dc.contributor.authorMartínez-Baz, Iván
dc.contributor.authorCasado, Itziar
dc.contributor.authorEcheverría, Aitziber
dc.contributor.authorTrobajo-Sanmartín, Camino
dc.contributor.authorCastilla, Jesús
dc.contributor.authorHansen, Christian Holm
dc.contributor.authorMoustsen-Helms, Ida Rask
dc.contributor.authorFabiani, Massimo
dc.contributor.authorMateo Urdiales, Alberto
dc.contributor.authorSacco, Chiara
dc.contributor.authorMeijerink, Hinta
dc.contributor.authorBråthen Kristoffersen, Anja
dc.contributor.authorSoares, Patricia
dc.contributor.authorMachado, Ausenda
dc.contributor.authorLjung, Rickard
dc.contributor.authorPihlström, Nicklas
dc.date.accessioned2026-03-06T15:08:41Z
dc.date.available2026-03-06T15:08:41Z
dc.date.issued2025-12
dc.description.abstractThe European Centre for Disease Prevention and Control (ECDC) started several vaccine effectiveness (VE) studies in 2020. These were included in the Vaccine Effectiveness, Burden and Impact Studies (VEBIS) project in 2021 to monitor VE in different settings and using different methods, and to provide information on different outcomes (severe disease, moderate disease, infection, transmission, etc) (1–3). Within the VEBIS project, the protocol describes the methods to estimate the Coronavirus disease 2019 (COVID-19) XBB.1.5. monovalent-adapted VE in immunocompromised persons (ICP), against COVID-19 hospitalisations and deaths, using established health data registries across six participating European Union/European Economic Area (EU/EEA) countries. The protocol is aimed at implementing a specific question that has been identified as an area where additional scientific evidence is beneficial, in the context of the ECDC/EMA Vaccine Monitoring Platform research agenda (4), adding on the routine vaccine effectiveness monitoring performed across the six countries (5). This work is performed within the VEBIS Lot 4 framework contract. The study design is a retrospective cohort study using data from ICPs eligible for COVID-19 vaccination at the start of the 2023 autumn vaccination campaign, collected routinely in electronic health record (EHR) databases. The study starts at the beginning of the vaccination campaign for each study site and ends 12 months after that. The study has two outcomes of interest: hospitalisations and deaths due to COVID-19. Data to be collected, besides the outcomes of interest, include sociodemographic (age, sex), clinical (ICP group) and COVID-19 vaccination history (brand, number of doses and dates of prior vaccine dose administration). The protocol outlines the study design and methods for analysing the data at country level and includes a plan for the pooled analysis across countries. This protocol is primarily intended to guide the implementation of the ECDC funded studies within the VEBIS project with a focus on specific objectives. Nevertheless, ECDC encourages the conduct of VE studies using this protocol and other VEBIS-related protocols as a basis in countries that do not currently plan to participate in ECDC-funded studies. Consistent protocols will facilitate the comparability of results across studies, countries, and sites.eng
dc.description.sponsorshipThis protocol was commissioned by the European Centre for Disease Prevention and Control (ECDC), as part of the activities within the Framework Contract (FWC) ECDC/2021/018 ‘Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza Lot 4’, coordinated by Nathalie Nicolay. Production of the protocol was coordinated by Nathalie Nicolay and Kate Olsson.
dc.identifier.doi10.2900/9569353
dc.identifier.isbn978-92-9498-851-5
dc.identifier.urihttp://hdl.handle.net/10400.18/11172
dc.language.isoeng
dc.peerreviewedn/a
dc.publisherEuropean Centre for Disease Prevention and Control
dc.relation.hasversionhttps://www.ecdc.europa.eu/sites/default/files/documents/protocol-covid-19-vaccine-effectiveness.pdf
dc.relation.ispartofseriesECDC Operational Support
dc.rights.uriN/A
dc.subjectECDC
dc.subjectXBB.1.5 VE
dc.subjectCOVID-19
dc.subjectInfecções Respiratórias
dc.subjectEstados de Saúde e de Doença
dc.titleProtocol to measure COVID-19 XBB.1.5 vaccine effectiveness in the immunocompromised population during the 2023 autumn vaccination campaigneng
dc.title.alternativeA multi-centre cohort study using electronic health records in EU/EAA countriespor
dc.typereport
dspace.entity.typePublication
oaire.citation.titleEuropean Centre for Disease Prevention and Control - Technical Report
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameNunes
person.familyNameSoares
person.familyNameMachado
person.givenNameBaltazar
person.givenNamePatricia
person.givenNameAusenda
person.identifier1050496
person.identifier.ciencia-idAB11-AD48-A8DF
person.identifier.ciencia-id0415-632D-8609
person.identifier.ciencia-id1217-6076-5D88
person.identifier.orcid0000-0001-6230-7209
person.identifier.orcid0000-0001-5033-9115
person.identifier.orcid0000-0002-1849-1499
person.identifier.scopus-author-id9133723200
person.identifier.scopus-author-id52063758300
relation.isAuthorOfPublicationbe4efa0d-49df-4a93-bfdd-b76d9f7bf492
relation.isAuthorOfPublicationdf1b8bab-1e35-4561-92d0-8aeb17371a29
relation.isAuthorOfPublication544ad266-0c22-4a50-9ebc-86acc08d6666
relation.isAuthorOfPublication.latestForDiscoverybe4efa0d-49df-4a93-bfdd-b76d9f7bf492

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