{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T15:55:11Z","timestamp":1793548511730,"version":"4.5.0"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T00:00:00Z","timestamp":1687219200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Merck, Sharp & Dohme LLC"},{"DOI":"10.13039\/100004334","name":"Merck & Co, Inc","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,10,13]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Individuals who receive allogeneic hematopoietic cell transplant (allo-HCT) are immunocompromised and at high risk of pneumococcal infections, especially in the months following transplant. This study evaluated the safety and immunogenicity of V114 (VAXNEUVANCE; Merck, Sharp &amp; Dohme LLC, a subsidiary of Merck &amp; Co., Inc., Rahway, NJ, USA), a 15-valent pneumococcal conjugate vaccine (PCV), when given to allo-HCT recipients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Participants received 3 doses of V114 or PCV13 (Prevnar 13; Wyeth LLC) in 1-month intervals starting 3\u20136 months after allo-HCT. Twelve months after HCT, participants received either PNEUMOVAX 23 or a fourth dose of PCV (if they experienced chronic graft vs host disease). Safety was evaluated as the proportion of participants with adverse events (AEs). Immunogenicity was evaluated by measuring serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) for all V114 serotypes in each vaccination group.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 274 participants were enrolled and vaccinated in the study. The proportions of participants with AEs and serious AEs were generally comparable between intervention groups, and the majority of AEs in both groups were of short duration and mild-to-moderate intensity. For both IgG GMCs and OPA GMTs, V114 was generally comparable to PCV13 for the 13 shared serotypes, and higher for serotypes 22F and 33F at day 90.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>V114 was well tolerated in allo-HCT recipients, with a generally comparable safety profile to PCV13. V114 induced comparable immune responses to PCV13 for the 13 shared serotypes, and was higher for V114 serotypes 22F and 33F. Study results support the use of V114 in allo-HCT recipients.<\/jats:p>\n                  <jats:p>Clinical Trials Registration.\u2003clinicaltrials.gov (NCT03565900) and European Union at EudraCT 2018-000066-11.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciad349","type":"journal-article","created":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T12:18:06Z","timestamp":1687263486000},"page":"1102-1110","source":"Crossref","is-referenced-by-count":17,"title":["A Phase 3, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate Safety, Tolerability, and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Allogeneic Hematopoietic Cell Transplant Recipients (PNEU-STEM)"],"prefix":"10.1093","volume":"77","author":[{"given":"Marissa","family":"Wilck","sequence":"first","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver A","family":"Cornely","sequence":"additional","affiliation":[{"name":"Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses In Aging-Associated Diseases (CECAD); Department of Internal Medicine , Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany"},{"name":"Excellence Center for Medical Mycology (ECMM); Clinical Trials Centre Cologne (ZKS K\u00f6ln), Faculty of Medicine and University Hospital Cologne , Cologne ,","place":["Germany"]},{"name":"German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne , Cologne ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Cordonnier","sequence":"additional","affiliation":[{"name":"Centre Hospitalier Universitaire Henri Mondor, Haematology and Cellular Therapy Department, Cr\u00e9teil and University Paris-Est Cr\u00e9teil, Cr\u00e9teil , France , FR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Diego","family":"Velez","sequence":"additional","affiliation":[{"name":"Fundacion Valle del Lili , Cali ,","place":["Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per","family":"Ljungman","sequence":"additional","affiliation":[{"name":"Karolinska University Hospital and Karolinska Institutet , Stockholm ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Maertens","sequence":"additional","affiliation":[{"name":"University Hospitals Leuven , Leuven, BE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominik","family":"Selleslag","sequence":"additional","affiliation":[{"name":"AZ St Jan , Brugge , BE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen M","family":"Mullane","sequence":"additional","affiliation":[{"name":"University of Chicago, Department of Medicine , Chicago , Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir","family":"Nabhan","sequence":"additional","affiliation":[{"name":"Instituto de Cancer e Transplante de Curitiba ICTR , Curitiba ,","place":["Puerto Rico"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiuxu","family":"Chen","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron","family":"Dagan","sequence":"additional","affiliation":[{"name":"The Shraga Segal Dept. of Microbiology, Immunology and Genetics, Faculty of Health Sciences of the Ben-Gurion University of the Negev , Beer-Sheva ,","place":["Israel"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Richmond","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Western Australia , Perth ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Daus","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kateasha","family":"Geddie","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gretchen","family":"Tamms","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tina","family":"Sterling","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shrita M","family":"Patel","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tulin","family":"Shekar","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luwy","family":"Musey","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrike K","family":"Buchwald","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the V114-022 (PNEU-STEM) Study 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transplant aged &gt;\/=2 years: an open-label study","volume":"61","author":"Cordonnier","year":"2015","journal-title":"Clin Infect Dis"},{"key":"2024111411415872500_ciad349-B6","doi-asserted-by":"crossref","first-page":"831","DOI":"10.1182\/blood-2002-03-0832","article-title":"Donor immunization with pneumococcal conjugate vaccine and early protective antibody responses following allogeneic hematopoietic cell transplantation","volume":"101","author":"Molrine","year":"2003","journal-title":"Blood"},{"key":"2024111411415872500_ciad349-B7","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1086\/511641","article-title":"Revaccination with measles, tetanus, poliovirus, Haemophilus influenzae type B, meningococcus C, and pneumococcus vaccines in children after hematopoietic stem cell transplantation","volume":"44","author":"Patel","year":"2007","journal-title":"Clin Infect 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haematopoietic stem cell transplantation recipients: a multicentre, randomized controlled trial","volume":"29","author":"Okinaka","year":"2023","journal-title":"Clin Microbiol Infect"},{"key":"2024111411415872500_ciad349-B17","doi-asserted-by":"crossref","first-page":"1022","DOI":"10.1016\/j.bbmt.2008.06.012","article-title":"Response to pneumococcal (PNCRM7) and haemophilus influenzae conjugate vaccines (HIB) in pediatric and adult recipients of an allogeneic hematopoietic cell transplantation (alloHCT)","volume":"14","author":"Pao","year":"2008","journal-title":"Biol Blood Marrow Transplant"},{"key":"2024111411415872500_ciad349-B18","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0177113","article-title":"Serotype distribution of Streptococcus pneumoniae causing invasive disease in children in the post-PCV era: a systematic review and meta-analysis","volume":"12","author":"Balsells","year":"2017","journal-title":"PLoS 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