{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T15:19:56Z","timestamp":1779376796037,"version":"3.53.1"},"reference-count":14,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T00:00:00Z","timestamp":1760486400000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"crossref","award":["PI24\/00214"],"award-info":[{"award-number":["PI24\/00214"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000780","name":"European Union","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"crossref"}]},{"name":"QIAGEN, Hilden, Germany"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,9,25]]},"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cytomegalovirus (CMV) infection is a common complication in patients undergoing haematopoietic stem cell transplantation (SCT). Letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, a study is needed to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualisation of CMV prophylaxis duration in these patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>INMUNOEND is a multicentre, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post SCT. Immunological and virological monitoring will be conducted until day+200 post-SCT. The primary outcome is the percentage of patients who develop clinically significant CMV infection up to day+200 post-SCT after completing LTV prophylaxis. Data collected will include baseline characteristics of the haematological diseases and comorbidities, variables related to SCT (ie, engrafment, graft-versus-host disease, use of LTV and CMV replication) and variables related to CMV-specific immune reconstitution.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been obtained from the institutional review board (Comit\u00e9 de \u00c9tica de la Investigaci\u00f3n de C\u00f3rdoba; SICEIA-2024\u20130\u200901\u2009762). The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06814301\">NCT06814301<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-101289","type":"journal-article","created":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T09:19:01Z","timestamp":1760519941000},"page":"e101289","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Impact of CMV-specific immune reconstitution at the end of letermovir prophylaxis on the development of late cytomegalovirus infection in haematopoietic stem cell transplant recipients (INMUNOEND): a protocol for a prospective, observational, multicentre study"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06814301","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7477-2033","authenticated-orcid":false,"given":"Juan Jos\u00e9","family":"Cast\u00f3n","sequence":"first","affiliation":[{"name":"Clinical Unit of Infectious Diseases, Hospital Universitario Reina Sofia, C\u00f3rdoba, Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain"},{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, Spain"},{"name":"Universidad de C\u00f3rdoba, C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9283-6188","authenticated-orcid":false,"given":"Clara","family":"Aparicio","sequence":"additional","affiliation":[{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, Spain"},{"name":"Department of Hematology, Hospital Universitario Reina Sof\u00eda, C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5344-3126","authenticated-orcid":false,"given":"Aurora","family":"Paez-Vega","sequence":"additional","affiliation":[{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-2445-3805","authenticated-orcid":false,"given":"Lorena","family":"Pozo L\u00f3pez","sequence":"additional","affiliation":[{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estefan\u00eda","family":"Garc\u00eda","sequence":"additional","affiliation":[{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, Spain"},{"name":"Department of Hematology, Hospital Universitario Reina Sof\u00eda, C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9574-0383","authenticated-orcid":false,"given":"Carmen","family":"Mart\u00edn","sequence":"additional","affiliation":[{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, Spain"},{"name":"Department of Hematology, Hospital Universitario Reina Sof\u00eda, C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5833-4834","authenticated-orcid":false,"given":"Elisa","family":"Ruiz-Arabi","sequence":"additional","affiliation":[{"name":"Clinical Unit of Infectious Diseases, Hospital Universitario Reina Sofia, C\u00f3rdoba, Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain"},{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda \u00c1ngeles","family":"Cuesta-Casas","sequence":"additional","affiliation":[{"name":"Department of Hematology, Hospital Regional Universitario de M\u00e1laga, M\u00e1laga, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Ar\u00e1nzazu","family":"Berm\u00fadez-Rodriguez","sequence":"additional","affiliation":[{"name":"Department of Hematology, Hospital Universitario Marques de Valdecilla, Santander, Spain"},{"name":"University of Cantabria, Santander, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Manuel","family":"Cerezo-Mart\u00edn","sequence":"additional","affiliation":[{"name":"Department of Hematology, Hospital Universitario Marques de Valdecilla, Santander, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro Antonio","family":"Gonz\u00e1lez-Sierra","sequence":"additional","affiliation":[{"name":"Department of Hematology, Hospital Universitario Virgen de las Nieves, Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3343-0085","authenticated-orcid":false,"given":"Isabel","family":"Machuca","sequence":"additional","affiliation":[{"name":"Clinical Unit of Infectious Diseases, Hospital Universitario Reina Sofia, C\u00f3rdoba, Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain"},{"name":"Instituto Maimonides de Investigacion Biomedica de Cordoba, C\u00f3rdoba, 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