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Purpose <p>The DANFLU-1 trial suggested lower incidence of hospitalizations for pneumonia and influenza, respiratory disease and all-cause mortality among older adults receiving high-dose (HD-IV) versus standard-dose (SD-IV) influenza vaccine. This study assessed the relative effectiveness of HD-IV versus SD-IV according to comorbidity in elderly individuals.</p> Methods <p>This was a post-hoc analysis of the DANFLU-1 randomized controlled feasibility trial of HD-IV versus SD-IV conducted during the 2021–2022 influenza season in adults aged 65–79 years. Outcomes assessed included influenza-related, respiratory, and cardiovascular hospitalizations, and mortality. We tested for effect modification by level of the Charlson Comorbidity Index (CCI) using ICD-10 codes up to 10 years prior to randomization.</p> Results <p>Of the 12,477 randomly assigned participants (mean age 71.7 ± 3.9 years, 47.1% female), 8,020 (64.3%) had CCI = 0, 3,560 (28.5%) had CCI = 1–2 and 893 (7.2%) had CCI ≥ 3. When comparing HD-IV with SD-IV, hazard ratios of hospitalizations for pneumonia and influenza were similar across CCI groups (HR [95%CI]: 0.15 [0.03–0.68] for CCI = 0, 0.36 [0.11–1.15] for CCI = 1–2, 1.00 [0.25-4.00] for CCI ≥ 3). Comparable patterns were found for hospitalizations for respiratory disease (0.46 [0.17–1.20] for CCI = 0, 0.67 [0.32–1.39] for CCI = 1–2, 0.66 [0.24–1.87] for CCI ≥ 3) and all-cause mortality (0.28 [0.09–0.86] for CCI = 0, 0.70 [0.30–1.63] for CCI = 1–2, 0.57 [0.24–1.36] for CCI ≥ 3). There was no statistical evidence of effect modification by CCI for any outcome.</p> Conclusions <p>The lower incidences of clinical outcomes for HD-IV compared to SD-IV were not significantly modified by CCI. The potential benefit of HD-IV versus SD-IV may therefore be applicable regardless of comorbidity burden. Further research is required to confirm these findings.</p>

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Relative effectiveness of high-dose versus standard-dose influenza vaccine against hospitalizations and mortality according to Charlson Comorbidity Index: A post-hoc analysis of the DANFLU-1 randomized trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月29日

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  • Katrine Feldballe Bernholm,
  • Niklas Dyrby Johansen,
  • Caroline Espersen,
  • Daniel Modin,
  • Kira Janstrup Hyldekær,
  • Joshua Nealon,
  • Sandrine Samson,
  • Matthew M. Loiacono,
  • Rebecca C. Harris,
  • Carsten Schade Larsen,
  • Anne Marie Reimer Jensen,
  • Nino Emanuel Landler,
  • Signe Tellerup Nielsen,
  • Lene Russell,
  • Theis Skovsgaard Itenov,
  • Brian L. Claggett,
  • Scott D. Solomon,
  • Martin J. Landray,
  • Gunnar H. Gislason,
  • Lars Køber,
  • Pradeesh Sivapalan,
  • Jens Ulrik Stæhr Jensen,
  • Tor Biering-Sørensen

摘要

Purpose

The DANFLU-1 trial suggested lower incidence of hospitalizations for pneumonia and influenza, respiratory disease and all-cause mortality among older adults receiving high-dose (HD-IV) versus standard-dose (SD-IV) influenza vaccine. This study assessed the relative effectiveness of HD-IV versus SD-IV according to comorbidity in elderly individuals.

Methods

This was a post-hoc analysis of the DANFLU-1 randomized controlled feasibility trial of HD-IV versus SD-IV conducted during the 2021–2022 influenza season in adults aged 65–79 years. Outcomes assessed included influenza-related, respiratory, and cardiovascular hospitalizations, and mortality. We tested for effect modification by level of the Charlson Comorbidity Index (CCI) using ICD-10 codes up to 10 years prior to randomization.

Results

Of the 12,477 randomly assigned participants (mean age 71.7 ± 3.9 years, 47.1% female), 8,020 (64.3%) had CCI = 0, 3,560 (28.5%) had CCI = 1–2 and 893 (7.2%) had CCI ≥ 3. When comparing HD-IV with SD-IV, hazard ratios of hospitalizations for pneumonia and influenza were similar across CCI groups (HR [95%CI]: 0.15 [0.03–0.68] for CCI = 0, 0.36 [0.11–1.15] for CCI = 1–2, 1.00 [0.25-4.00] for CCI ≥ 3). Comparable patterns were found for hospitalizations for respiratory disease (0.46 [0.17–1.20] for CCI = 0, 0.67 [0.32–1.39] for CCI = 1–2, 0.66 [0.24–1.87] for CCI ≥ 3) and all-cause mortality (0.28 [0.09–0.86] for CCI = 0, 0.70 [0.30–1.63] for CCI = 1–2, 0.57 [0.24–1.36] for CCI ≥ 3). There was no statistical evidence of effect modification by CCI for any outcome.

Conclusions

The lower incidences of clinical outcomes for HD-IV compared to SD-IV were not significantly modified by CCI. The potential benefit of HD-IV versus SD-IV may therefore be applicable regardless of comorbidity burden. Further research is required to confirm these findings.