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Diabetes Obes Metab
. 2024 May;26(5):1821-1829.
doi: 10.1111/dom.15498. Effects of high-dose versus standard-dose quadrivalent influenza vaccine among patients with diabetes: A post-hoc analysis of the DANFLU-1 trial
Mats C Højbjerg Lassen 1 2 3 , Niklas Dyrby Johansen 1 2 , Daniel Modin 1 2 , Joshua Nealon 4 , Sandrine Samson 4 , Marine Dufournet 4 , Matthew M Loiacono 5 , Carsten Schade Larsen 6 , Anne Marie Reimer Jensen 1 2 , Nino Emanuel Landler 1 2 , Brian L Claggett 3 , Scott D Solomon 3 , Martin J Landray 7 8 , Gunnar H Gislason 1 9 10 11 , Lars Køber 9 12 , Jens Ulrik Stæhr Jensen 13 , Pradeesh Sivapalan 9 13 , Lasse Skafte Vestergaard 14 , Tyra Grove Krause 14 , Tor Biering-Sørensen 1 2 12 15
Affiliations
Aim: High-dose quadrivalent influenza vaccine (QIV-HD) has been shown to be more effective than standard-dose (QIV-SD) in reducing influenza infection, but whether diabetes status affects relative vaccine effectiveness (rVE) is unknown. We aimed to assess rVE on change in glycated haemoglobin [HbA1c (∆HbA1c)], incident diabetes, total all-cause hospitalizations (first + recurrent), and a composite of all-cause mortality and hospitalization for pneumonia or influenza.
Methods: DANFLU-1 was a pragmatic, open-label trial randomizing adults (65-79 years) 1:1 to QIV-HD or QIV-SD during the 2021/22 influenza season. Cox proportional hazards regression was used to estimate rVE against incident diabetes and the composite endpoint, negative binomial regression to estimate rVE against all-cause hospitalizations, and ANCOVA when assessing rVE against ∆HbA1c.
Results: Of the 12 477 participants, 1162 (9.3%) had diabetes at baseline. QIV-HD, compared with QIV-SD, was associated with a reduction in the rate of all-cause hospitalizations irrespective of diabetes [overall: 647 vs. 742 events, incidence rate ratio (IRR): 0.87, 95% CI (0.76-0.99); diabetes: 93 vs. 118 events, IRR: 0.80, 95% CI (0.55-1.15); without diabetes: 554 vs. 624 events, IRR: 0.88, 95% CI (0.76-1.01), pinteraction = 0.62]. Among those with diabetes, QIV-HD was associated with a lower risk of the composite outcome [2 vs. 11 events, HR: 0.18, 95% CI (0.04-0.83)] but had no effect on ∆HbA1c; QIV-HD adjusted mean difference: ∆ + 0.2 mmol/mol, 95% CI (-0.9 to 1.2). QIV-HD did not affect the risk of incident diabetes [HR 1.18, 95% CI (0.94-1.47)].
Conclusions: In this post-hoc analysis, QIV-HD versus QIV-SD was associated with an increased rVE against the composite of all-cause death and hospitalization for pneumonia/influenza, and the all-cause hospitalization rate irrespective of diabetes status.
Keywords: diabetes; influenza; pragmatic; randomized controlled trial; registry; vaccine.
. 2024 May;26(5):1821-1829.
doi: 10.1111/dom.15498. Effects of high-dose versus standard-dose quadrivalent influenza vaccine among patients with diabetes: A post-hoc analysis of the DANFLU-1 trial
Mats C Højbjerg Lassen 1 2 3 , Niklas Dyrby Johansen 1 2 , Daniel Modin 1 2 , Joshua Nealon 4 , Sandrine Samson 4 , Marine Dufournet 4 , Matthew M Loiacono 5 , Carsten Schade Larsen 6 , Anne Marie Reimer Jensen 1 2 , Nino Emanuel Landler 1 2 , Brian L Claggett 3 , Scott D Solomon 3 , Martin J Landray 7 8 , Gunnar H Gislason 1 9 10 11 , Lars Køber 9 12 , Jens Ulrik Stæhr Jensen 13 , Pradeesh Sivapalan 9 13 , Lasse Skafte Vestergaard 14 , Tyra Grove Krause 14 , Tor Biering-Sørensen 1 2 12 15
Affiliations
- PMID: 38586966
- DOI: 10.1111/dom.15498
Aim: High-dose quadrivalent influenza vaccine (QIV-HD) has been shown to be more effective than standard-dose (QIV-SD) in reducing influenza infection, but whether diabetes status affects relative vaccine effectiveness (rVE) is unknown. We aimed to assess rVE on change in glycated haemoglobin [HbA1c (∆HbA1c)], incident diabetes, total all-cause hospitalizations (first + recurrent), and a composite of all-cause mortality and hospitalization for pneumonia or influenza.
Methods: DANFLU-1 was a pragmatic, open-label trial randomizing adults (65-79 years) 1:1 to QIV-HD or QIV-SD during the 2021/22 influenza season. Cox proportional hazards regression was used to estimate rVE against incident diabetes and the composite endpoint, negative binomial regression to estimate rVE against all-cause hospitalizations, and ANCOVA when assessing rVE against ∆HbA1c.
Results: Of the 12 477 participants, 1162 (9.3%) had diabetes at baseline. QIV-HD, compared with QIV-SD, was associated with a reduction in the rate of all-cause hospitalizations irrespective of diabetes [overall: 647 vs. 742 events, incidence rate ratio (IRR): 0.87, 95% CI (0.76-0.99); diabetes: 93 vs. 118 events, IRR: 0.80, 95% CI (0.55-1.15); without diabetes: 554 vs. 624 events, IRR: 0.88, 95% CI (0.76-1.01), pinteraction = 0.62]. Among those with diabetes, QIV-HD was associated with a lower risk of the composite outcome [2 vs. 11 events, HR: 0.18, 95% CI (0.04-0.83)] but had no effect on ∆HbA1c; QIV-HD adjusted mean difference: ∆ + 0.2 mmol/mol, 95% CI (-0.9 to 1.2). QIV-HD did not affect the risk of incident diabetes [HR 1.18, 95% CI (0.94-1.47)].
Conclusions: In this post-hoc analysis, QIV-HD versus QIV-SD was associated with an increased rVE against the composite of all-cause death and hospitalization for pneumonia/influenza, and the all-cause hospitalization rate irrespective of diabetes status.
Keywords: diabetes; influenza; pragmatic; randomized controlled trial; registry; vaccine.