TY - JOUR
T1 - Effects of high-dose versus standard-dose influenza vaccine among patients with chronic lung disease
T2 - A prespecified analysis of the DANFLU-1 trial
AU - Duus, Lisa Steen
AU - Johansen, Niklas Dyrby
AU - Modin, Daniel
AU - Janstrup, Kira Hyldekær
AU - Nealon, Joshua
AU - Samson, Sandrine
AU - Loiacono, Matthew M
AU - Harris, Rebecca C
AU - Larsen, Carsten Schade
AU - Reimer Jensen, Anne Marie
AU - Claggett, Brian L
AU - Solomon, Scott D
AU - Landray, Martin J
AU - Gislason, Gunnar H
AU - Køber, Lars
AU - Sivapalan, Pradeesh
AU - Stæhr Jensen, Jens Ulrik
AU - Biering-Sørensen, Tor
N1 - Copyright © 2025 The Author. Published by Elsevier B.V. All rights reserved.
PY - 2025/11
Y1 - 2025/11
N2 - BACKGROUND: Individuals with chronic lung disease (CLD) face an increased risk of influenza-related complications and mortality, and seasonal vaccination is recommended. Limited evidence exists on the effectiveness of high-dose (HD-IIV) vs. standard-dose (SD-IIV) inactivated influenza vaccines in this population.METHODS: DANFLU-1 trial was a pragmatic, open-label, randomized trial comparing HD-IIV vs. SD-IIV in adults aged 65-79 years during the 2021/2022 influenza season. Vaccines were allocated 1:1. CLD was identified using ICD-10 codes. The prespecified outcomes were hospitalizations due to pneumonia or influenza, respiratory, cardiovascular, cardiorespiratory, and all-cause hospitalizations, and mortality.RESULTS: The study population included 12,477 participants (mean age 71.7 ± 3.9 years, 47 % female), of whom 850 (6.8 %) had CLD. Hospitalization rates for all outcomes were significantly higher among participants with CLD. HD-IIV was associated with a lower risk of hospitalization for pneumonia or influenza (HR 0.36 (CI: 0.17-0.73); no CLD: HR 0.22 (CI: 0.08-0.57); CLD: HR 0.95 (CI: 0.28-3.30); p for interaction = 0.064), respiratory hospitalization, and all-cause mortality, and a lower incidence rate of all-cause hospitalization. Effect estimates were less favorable for HD-IIV compared to SD-IIV among CLD patients in preventing respiratory disease hospitalization and all-cause mortality.CONCLUSION: In this prespecified analysis of the DANFLU-1 randomized trial of HD-IIV vs. SD-IIV, trends suggested that among participants with CLD, the benefit of HD-IIV may be attenuated compared with those without CLD, particularly in relation to respiratory disease hospitalization and all-cause mortality. Given the small sample size, these results should be considered hypothesis-generating and require further investigation.TRIAL REGISTRATION: ClinicalTrials.gov: NCT05048589.
AB - BACKGROUND: Individuals with chronic lung disease (CLD) face an increased risk of influenza-related complications and mortality, and seasonal vaccination is recommended. Limited evidence exists on the effectiveness of high-dose (HD-IIV) vs. standard-dose (SD-IIV) inactivated influenza vaccines in this population.METHODS: DANFLU-1 trial was a pragmatic, open-label, randomized trial comparing HD-IIV vs. SD-IIV in adults aged 65-79 years during the 2021/2022 influenza season. Vaccines were allocated 1:1. CLD was identified using ICD-10 codes. The prespecified outcomes were hospitalizations due to pneumonia or influenza, respiratory, cardiovascular, cardiorespiratory, and all-cause hospitalizations, and mortality.RESULTS: The study population included 12,477 participants (mean age 71.7 ± 3.9 years, 47 % female), of whom 850 (6.8 %) had CLD. Hospitalization rates for all outcomes were significantly higher among participants with CLD. HD-IIV was associated with a lower risk of hospitalization for pneumonia or influenza (HR 0.36 (CI: 0.17-0.73); no CLD: HR 0.22 (CI: 0.08-0.57); CLD: HR 0.95 (CI: 0.28-3.30); p for interaction = 0.064), respiratory hospitalization, and all-cause mortality, and a lower incidence rate of all-cause hospitalization. Effect estimates were less favorable for HD-IIV compared to SD-IIV among CLD patients in preventing respiratory disease hospitalization and all-cause mortality.CONCLUSION: In this prespecified analysis of the DANFLU-1 randomized trial of HD-IIV vs. SD-IIV, trends suggested that among participants with CLD, the benefit of HD-IIV may be attenuated compared with those without CLD, particularly in relation to respiratory disease hospitalization and all-cause mortality. Given the small sample size, these results should be considered hypothesis-generating and require further investigation.TRIAL REGISTRATION: ClinicalTrials.gov: NCT05048589.
KW - Asthma
KW - Chronic obstructive pulmonary disease
KW - Influenza
KW - Pragmatic
KW - Randomized controlled trial
U2 - 10.1016/j.resinv.2025.10.016
DO - 10.1016/j.resinv.2025.10.016
M3 - Journal article
C2 - 41177098
SN - 2212-5345
VL - 63
SP - 1309
EP - 1315
JO - Respiratory investigation
JF - Respiratory investigation
IS - 6
ER -