Effectiveness of high-dose versus standard-dose quadrivalent influenza vaccine against recurrent hospitalizations and mortality in relation to influenza circulation: A post-hoc analysis of the DANFLU-1 randomized clinical trial.

Autor:	Johansen ND; Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen, Denmark., Modin D; Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen, Denmark., Skaarup KG; Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen, Denmark., Nealon J; School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, China., Samson S; Sanofi, Lyon, France., Dufournet M; Sanofi, Lyon, France., Loiacono MM; Sanofi, Swiftwater, PA, USA., Harris RC; Sanofi, Singapore., Larsen CS; Department of Clinical Medicine, Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark., Jensen AMR; Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen, Denmark., Landler NE; Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen, Denmark., Claggett BL; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Solomon SD; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Landray MJ; Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Public Health, University of Oxford, Oxford, United Kingdom; Big Data Institute, University of Oxford, Oxford, United Kingdom., Gislason GH; Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; The Danish Heart Foundation, Copenhagen, Denmark; The National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark., Køber L; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark., Jensen JUS; Department of Medicine, Respiratory Medicine Section, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark., Sivapalan P; Department of Medicine, Respiratory Medicine Section, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark., Vestergaard LS; Epidemiological Infectious Disease Preparedness, Statens Serum Institut, Copenhagen, Denmark., Valentiner-Branth P; Epidemiological Infectious Disease Preparedness, Statens Serum Institut, Copenhagen, Denmark., Krause TG; Epidemiological Infectious Disease Preparedness, Statens Serum Institut, Copenhagen, Denmark., Biering-Sørensen T; Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte, Copenhagen, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, Center for Translational Cardiology and Pragmatic Randomized Trials, University of Copenhagen, Denmark. Electronic address: tor.biering@gmail.com.
Jazyk:	angličtina
Zdroj:	Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2024 Nov; Vol. 30 (11), pp. 1453-1459. Date of Electronic Publication: 2024 Jan 28.
DOI:	10.1016/j.cmi.2024.01.017
Abstrakt:	Objectives: To evaluate the relative effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) versus standard-dose quadrivalent influenza vaccine (QIV-SD) against recurrent hospitalizations and its potential variation in relation to influenza circulation. Methods: We did a post-hoc analysis of a pragmatic, open-label, randomized trial of QIV-HD versus QIV-SD performed during the 2021-2022 influenza season among adults aged 65-79 years. Participants were enrolled in October 2021-November, 2021 and followed for outcomes from 14 days postvaccination until 31 May, 2022. We investigated the following outcomes: Hospitalizations for pneumonia or influenza, respiratory hospitalizations, cardio-respiratory hospitalizations, cardiovascular hospitalizations, all-cause hospitalizations, and all-cause death. Outcomes were analysed as recurrent events. Cumulative numbers of events were assessed weekly. Cumulative relative effectiveness estimates were calculated and descriptively compared with influenza circulation. The trial is registered at Clinicaltrials.gov: NCT05048589. Results: Among 12,477 randomly assigned participants, receiving QIV-HD was associated with lower incidence rates of hospitalizations for pneumonia or influenza (10 vs. 33 events, incidence rate ratio [IRR] 0.30 [95% CI, 0.14-0.64]; p 0.002) and all-cause hospitalizations (647 vs. 742 events, IRR 0.87 [95% CI, 0.76-0.99]; p 0.032) compared with QIV-SD. Trends favouring QIV-HD were consistently observed over time including in the period before active influenza transmission; i.e. while the first week with a ≥10% influenza test positivity rate was calendar week 10, 2022, the first statistically significant reduction in hospitalizations for pneumonia or influenza was already observed by calendar week 3, 2022 (5 vs. 15 events, IRR 0.33 [95% CI, 0.11-0.94]; p 0.037). Discussion: In a post-hoc analysis, QIV-HD was associated with lower incidence rates of hospitalizations for pneumonia or influenza and all-cause hospitalizations compared with QIV-SD, with trends evident independent of influenza circulation levels. Our exploratory results correspond to a number needed to treat of 65 (95% CI 35-840) persons vaccinated with QIV-HD compared with QIV-SD to prevent one additional all-cause hospitalization per season. Further research is needed to confirm these hypothesis-generating findings. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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