{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T05:21:36Z","timestamp":1767244896904,"version":"3.48.0"},"reference-count":42,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T00:00:00Z","timestamp":1767052800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AstraZeneca"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: Pre-exposure passive immune prophylaxis (PrEP) might contribute to improve hematologic malignancy (HM) outcomes; however, there are currently no specific guidelines to inform patient selection. Methods: A literature review and a Delphi consensus process were used to identify COVID-19 risk factors, critical COVID-19 outcomes, and efficacy of PrEP against SARS-CoV-2 in HMs. An analytic hierarchy process was used to assign a priority score to candidate outcomes and to determine the PrEP indications. For these decisions, the experts assumed adequate compliance with anti-COVID-19 vaccination and acknowledged the effectiveness of PrEP in reducing SARS-CoV-2-related mortality and hospital admissions. Results: Based on the literature review, the expert panel identified 80 risk categories among patients with HM and prioritized eight clinical outcomes related to SARS-CoV-2 PrEP. The highest mean priority scores were observed for HM-related mortality (7.0), intensive care unit admission (6.7), and delays in anti-HM treatment (6.6). Based on such a framework, the experts deemed that if there was a variant-specific PrEP promptly available, it would be considered mandatory for all candidates receiving allogeneic hematopoietic cell transplantation, CAR-T therapy, or bispecific antibodies, regardless of local viral epidemiology. During epidemiological waves, variant-specific PrEP would also be recommended for patients with HMs at high risk of unfavorable COVID-19 clinical outcomes. Conclusions: This study identified PrEP indications for patients with HM receiving appropriate active immunization against COVID-19.<\/jats:p>","DOI":"10.3390\/vaccines14010046","type":"journal-article","created":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T16:08:00Z","timestamp":1767197280000},"page":"46","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Key Indications for Passive Immune Prophylaxis Against SARS-CoV-2 Infection in Malignant Hematological Disorders: An Analytic Hierarchy Process by an Ad Hoc Italian Expert Panel"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7615-0572","authenticated-orcid":false,"given":"Monia","family":"Marchetti","sequence":"first","affiliation":[{"name":"Hematology and Transplant Unit, Azienda Ospedaliera Universitaria di Alessandria, University of Eastern Pedemont, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8357-7192","authenticated-orcid":false,"given":"Giovanni","family":"Barosi","sequence":"additional","affiliation":[{"name":"Center for the Study of Myelofibrosis, Scientific Direction, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo Foundation, 27100 Pavia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Passamonti","sequence":"additional","affiliation":[{"name":"Hematology Division, Foundation IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy"},{"name":"Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Falcone","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Azienda Osperdaliero Universitaria Pisana, University of Pisa, 56126 Pisa, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5606-8712","authenticated-orcid":false,"given":"Emanuele","family":"Nicastri","sequence":"additional","affiliation":[{"name":"National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, 00149 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simona","family":"Sica","sequence":"additional","affiliation":[{"name":"Department of Laboratory and Hematological Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy"},{"name":"Hematology Section, Department of Radiological and Hematological Sciences, Catholic University of the Sacred Heart, 20123 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pellegrino","family":"Musto","sequence":"additional","affiliation":[{"name":"Hematology and Stem Cell Transplantation Unit, AOUC Policlinico, 70124 Bari, Italy"},{"name":"Department of Precision and Regenerative Medicine and Ionian Area, \u201cAldo Moro\u201d University School of Medicine, 70121 Bari, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2425-9474","authenticated-orcid":false,"given":"Francesca Romana","family":"Mauro","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corrado","family":"Girmenia","sequence":"additional","affiliation":[{"name":"Dipartimento di Attivit\u00e0 Cliniche Onco-Ematologiche, Dermatologiche e della Diagnostica Anatomo-Patologica, Azienda Ospedaliera Universitaria Policlinico Umberto I, 00161 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,12,30]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2025, October 01). COVID-19 Epidemiological Update: Special Edition. Available online: https:\/\/cdn.who.int\/media\/docs\/default-source\/documents\/emergencies\/20241224_covid-19_epi_update_special-edition.pdf?sfvrsn=b0a6ddaf_1&download=true."},{"key":"ref_2","unstructured":"World Health Organization (2025, October 01). COVID-19 Global Risk Assessment. Available online: https:\/\/www.who.int\/publications\/m\/item\/covid-19-global-risk-assessment."},{"key":"ref_3","unstructured":"World Health Organization Data (2025, October 01). WHO COVID-19 dashboard. Available online: https:\/\/data.who.int\/dashboards\/covid19\/summary."},{"key":"ref_4","unstructured":"(2025, October 01). European Centre for Disease Prevention and Control. Available online: www.ecdc.europa.eu\/en\/news-events\/slow-increases-covid-19-observed-across-eueea-new-variant-emerges."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1016\/j.idc.2025.02.005","article-title":"Navigating Coronavirus Disease 2019 in Immunocompromised Populations: Evolving Risk Factors, Treatment, and Outcomes","volume":"39","author":"Alsoubani","year":"2025","journal-title":"Infect. Dis. Clin. N. Am."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"236","DOI":"10.1182\/blood.2021012251","article-title":"COVID-19 in patients with hematologic malignancy. Risk Factors for Pediatric Critical COVID-19: A Systematic Review and Meta-Analysis","volume":"140","author":"Langerbeins","year":"2022","journal-title":"Blood"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"352","DOI":"10.1093\/jpids\/piae052","article-title":"Risk Factors for Pediatric Critical COVID-19: A Systematic Review and Meta-Analysis","volume":"13","author":"Aparicio","year":"2024","journal-title":"J. Pediatr. Infect. Dis. Soc."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"2275","DOI":"10.1007\/s10238-023-01027-y","article-title":"Outcome of COVID-19 patients with haematological malignancies after the introduction of vaccination and monoclonal antibodies: Results from the HM-COV 2.0 study","volume":"23","author":"Oliva","year":"2023","journal-title":"Clin. Exp. Med."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1588","DOI":"10.1182\/blood.2021014124","article-title":"COVID-19 in vaccinated adult patients with hematological malignancies: Preliminary results from EPICOVIDEHA","volume":"139","author":"Pagano","year":"2022","journal-title":"Blood"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"578","DOI":"10.1016\/j.ccell.2022.04.015","article-title":"COVID-19 in patients with lymphoproliferative diseases during the Omicron variant surge","volume":"40","author":"Bronstein","year":"2022","journal-title":"Cancer Cell"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1295","DOI":"10.1182\/blood-2024-203228","article-title":"Associations of Lineage-Specific Clonal Hematopoiesis with COVID-19 Hospitalization and Mortality","volume":"144","author":"Choudhri","year":"2024","journal-title":"Blood"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1945","DOI":"10.1007\/s10238-023-01004-5","article-title":"Mortality of COVID-19 in patients with hematological malignancies versus solid tumors: A systematic literature review and meta-analysis","volume":"23","author":"Hardy","year":"2023","journal-title":"Clin. Exp. Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1125","DOI":"10.1007\/s15010-023-02169-7","article-title":"Need for ICU and outcome of critically ill patients with COVID-19 and haematological malignancies: Results from the EPICOVIDEHA survey","volume":"52","author":"Lahmer","year":"2024","journal-title":"Infection"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"113603","DOI":"10.1016\/j.ejca.2024.113603","article-title":"Effectiveness and safety of COVID-19 vaccination in people with blood cancer","volume":"201","author":"Copland","year":"2024","journal-title":"Eur. J. Cancer"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e737","DOI":"10.1016\/S2352-3026(20)30251-9","article-title":"Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: A retrospective, multicentre, cohort study","volume":"7","author":"Passamonti","year":"2020","journal-title":"Lancet Haematol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1099","DOI":"10.1002\/jmv.26404","article-title":"The outcome of COVID-19 in patients with hematological malignancy","volume":"93","author":"Yigenoglu","year":"2021","journal-title":"J. Med. Virol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"597","DOI":"10.1111\/ejh.13493","article-title":"Clinical course and risk factors for mortality from COVID-19 in patients with haematological malignancies","volume":"105","author":"Colmenares","year":"2020","journal-title":"Eur. J. Haematol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"100747","DOI":"10.1016\/j.lanepe.2023.100747","article-title":"Impact of COVID-19 on immunocompromised populations during the Omicron era: Insights from the observational population-based INFORM study","volume":"35","author":"Evans","year":"2023","journal-title":"Lancet Reg. Health Eur."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1111\/bjh.18823","article-title":"COVID-19 infection in patients with haematological malignancies: A single-centre survey in the latest Omicron wave in China","volume":"202","author":"Zhu","year":"2023","journal-title":"Br. J. Haematol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1474","DOI":"10.1080\/10428194.2024.2361099","article-title":"Risk of SARS-CoV-2 infection and severe COVID-19 in hematological patients who received or not pre-exposure prophylaxis with tixagevimab\/cilgavimab: A target trial emulation","volume":"65","author":"Falcone","year":"2024","journal-title":"Leuk. Lymphoma"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"107042","DOI":"10.1016\/j.ijid.2024.107042","article-title":"Risk of SARS-CoV-2 infection in patients with hematologic diseases receiving tixagevimab\/cilgavimab as pre-exposure prophylaxis in most recent Omicron sublineages era","volume":"144","author":"Vergori","year":"2024","journal-title":"Int. J. Infect. Dis."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Schmidt, K., Aumann, I., Hollander, I., Damm, K., and von der Schulenburg, J.M. (2015). Applying the Analytic Hierarchy Process in healthcare research: A systematic literature review and evaluation of reporting. BMC Med. Inform. Decis. Mak., 15.","DOI":"10.1186\/s12911-015-0234-7"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1038\/s41408-022-00776-5","article-title":"Immunogenicity and risks associated with impaired immune responses following SARS-CoV-2 vaccination and booster in hematologic malignancy patients: An updated meta-analysis","volume":"12","author":"Uaprasert","year":"2022","journal-title":"Blood Cancer J."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1186\/s13045-022-01233-3","article-title":"Serologic response following SARS-CoV-2 vaccination in patients with cancer: A systematic review and meta-analysis","volume":"15","author":"Sakuraba","year":"2022","journal-title":"J. Hematol. Oncol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1840","DOI":"10.3324\/haematol.2021.280163","article-title":"Antibody response after vaccination against SARSCoV-2 in adults with hematological malignancies: A systematic review and meta-analysis","volume":"107","author":"Gagelmann","year":"2022","journal-title":"Haematologica."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1016\/j.ejca.2022.05.029","article-title":"Booster doses of COVID-19 vaccines for patients with haematological and solid cancer: A systematic review and individual patient data meta-analysis","volume":"172","author":"Mai","year":"2022","journal-title":"Eur. J. Cancer"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"109046","DOI":"10.1016\/j.intimp.2022.109046","article-title":"A systematic review and meta-analysis of immune response against first and second doses of SARS-CoV-2 vaccines in adult patients with hematological malignancies","volume":"110","author":"Noori","year":"2022","journal-title":"Int. Immunopharmacol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1182\/blood-2024-211949","article-title":"COVID-19 Humoral Immunity Improves with Third and Subsequent Vaccine Doses in Patients with Plasma Cell Dyscrasias, Particularly in Those Receiving antiCD38 Therapy","volume":"144","author":"Bhella","year":"2024","journal-title":"Blood"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"3532","DOI":"10.1182\/blood-2024-204417","article-title":"Waning Long Term Efficacy of COVID-19 Post-Transplant Vaccination for Prevention of COVID-19 Adverse Events in Transplant and Cellular Therapy (TCT) Patients","volume":"144","author":"Ramaswamy","year":"2024","journal-title":"Blood"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"3058","DOI":"10.3324\/haematol.2023.283015","article-title":"Predictors of SARS-CoV-2 Omicron breakthrough infection after receipt of AZD7442 (tixagevimab-cilgavimab) for pre-exposure prophylaxis among hematologic malignancy patients","volume":"108","author":"Laracy","year":"2023","journal-title":"Haematologica"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"981","DOI":"10.1007\/s00277-023-05572-0","article-title":"Effectiveness of tixagevimab\/cilgavimab in patients with hematological malignancies as a pre-exposure prophylaxis to prevent severe COVID-19: A Czech retrospective multicenter study","volume":"103","author":"Demel","year":"2024","journal-title":"Ann. Hematol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"1600","DOI":"10.1080\/10428194.2023.2224472","article-title":"Breakthrough COVID-19 is mild in vaccinated patients with hematological malignancy receiving tixagevimab-cilgavimab as pre-exposure prophylaxis","volume":"64","author":"Hall","year":"2023","journal-title":"Leuk. Lymphoma"},{"key":"ref_33","unstructured":"US Food Drug Administration FDA (2024, November 08). Announces Evusheld Is Not Currently Authorized for Emergency Use in the US, Available online: https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-announces-evusheld-not-currently-authorized-emergency-use-us."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"813","DOI":"10.1016\/S1473-3099(24)00804-1","article-title":"Efficacy and safety of sipavibart for prevention of COVID-19 in individuals who are immunocompromised (SUPERNOVA): A randomised, controlled, double-blind, phase 3 trial","volume":"25","author":"Haidar","year":"2025","journal-title":"Lancet Infect. Dis."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"713","DOI":"10.1016\/S1473-3099(24)00812-0","article-title":"Sipavibart: When a success changes into a failure","volume":"25","author":"Focosi","year":"2025","journal-title":"Lancet Infect. Dis."},{"key":"ref_36","unstructured":"(2025, January 25). Analyze Single Variant; F456L Lineages in the World. Available online: https:\/\/cov-spectrum.org\/explore\/World\/AllSamples\/Past1M\/variants?aaMutations=S%3AF456L&."},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"Bhimraj, A., Falck-Ytter, Y., Baden, L.R., Bedimo, R., Cawcutt, K., Cheng, V.C., Chew, K.W., Chiotos, K., Daar, E.S., and Dzierba, A.L. (2025). 2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Pemivibart for Pre-exposure Prophylaxis, Vilobelimab for Critical Illness, and Abatacept or Infliximab for Severe or Critical Illness. Clin. Infect. Dis., ciaf424.","DOI":"10.1093\/cid\/ciaf424"},{"key":"ref_38","unstructured":"(2025, October 01). Invivyd Announces Continued Neutralizing Activity of PEMGARDA\u00ae (Pemivibart) and VYD2311 Against Currently Dominant SARS-CoV-2 Variant XFG (\u201cStratus\u201d). Available online: https:\/\/investors.adagiotx.com\/news-releases\/news-release-details\/invivyd-announces-continued-neutralizing-activity-pemgardar\/."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"5040","DOI":"10.1038\/s41467-025-60250-1","article-title":"Ultrapotent SARS coronavirus-neutralizing single-domain antibodies that clamp the spike at its base","volume":"16","author":"Shoemaker","year":"2025","journal-title":"Nat. Commun."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"16269","DOI":"10.1038\/s41598-025-00555-9","article-title":"Epitope mapping of SARS-CoV-2 Spike protein using naturally-acquired immune responses to develop monoclonal antibodies","volume":"15","author":"Aguilar","year":"2025","journal-title":"Sci. Rep."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"2499595","DOI":"10.1080\/19420862.2025.2499595","article-title":"Integrating immune library probing with structure-based computational design to develop potent neutralizing nanobodies against emerging SARS-CoV-2 variants","volume":"17","author":"Silva","year":"2025","journal-title":"mAbs"},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"eadq5720","DOI":"10.1126\/scitranslmed.adq5720","article-title":"Bispecific antibodies targeting the N-terminal and receptor binding domains potently neutralize SARS-CoV-2 variants of concern","volume":"17","author":"Rubio","year":"2025","journal-title":"Sci. Transl. Med."}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/14\/1\/46\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T05:18:08Z","timestamp":1767244688000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/14\/1\/46"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,30]]},"references-count":42,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1]]}},"alternative-id":["vaccines14010046"],"URL":"https:\/\/doi.org\/10.3390\/vaccines14010046","relation":{},"ISSN":["2076-393X"],"issn-type":[{"type":"electronic","value":"2076-393X"}],"subject":[],"published":{"date-parts":[[2025,12,30]]}}}