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J Infect
. 2024 Sep 18:106276.
doi: 10.1016/j.jinf.2024.106276. Online ahead of print. Time of day for vaccination, outcomes, and relative effectiveness of high-dose vs. standard-dose quadrivalent influenza vaccine: a post-hoc analysis of the DANFLU-1 randomized clinical trial
Jacob Christensen 1 , Niklas Dyrby Johansen 1 , Kira Hyldekær Janstrup 1 , Daniel Modin 1 , Kristoffer Grundtvig Skaarup 1 , Joshua Nealon 2 , Sandrine Samson 2 , Matthew Loiacono 3 , Rebecca Harris 4 , Carsten Schade Larsen 5 , Anne Marie Reimer Jensen 1 , Nino Emanuel Landler 1 , Brian L Claggett 6 , Scott D Solomon 7 , Gunnar H Gislason 8 , Lars Køber 9 , Martin J Landray 10 , Pradeesh Sivapalan 11 , Jens Ulrik Stæhr Jensen 11 , Tor Biering-Sørensen 12
Affiliations
Objectives: Morning influenza vaccination enhances antibody response. In this posthoc analysis of the DANFLU-1 trial, we sought to evaluate the association between time of day for vaccination (ToV) and outcomes, and whether ToV modified the relative effectiveness of high-dose (QIV-HD) vs. standard-dose (QIV-SD) quadrivalent influenza vaccine.
Methods: DANFLU-1 was a pragmatic feasibility trial of QIV-HD vs. QIV-SD. Outcomes included hospitalizations and mortality. For subgroup analysis, the population was dichotomized at median ToV into two groups (early and late).
Results: The study population included 12,477 participants. Mean age was 71.7±3.9 years with 5,877 (47.1%) female participants. Median ToV was 11.29AM. Earlier ToV was associated with fewer respiratory hospitalizations independent of vaccine type, which persisted in adjusted analysis (IRR 0.88 per 1-hour decrement (95% CI 0.78- 0.98, p=0.025). No effect modification by continuous or dichotomous ToV was found. In subgroup analysis, effects consistently favored QIV-HD against hospitalizations for pneumonia or influenza (early: IRR 0.30; late: 0.29), all-cause hospitalizations (early: IRR 0.87; late: 0.86), and mortality (early: HR 0.53; late: 0.50).
Conclusion: In this exploratory post-hoc analysis, earlier ToV was associated with fewer respiratory hospitalizations. The relative effectiveness of QIV-HD vs. QIV-SD was not modified by ToV. Further research is needed to confirm findings.
Trial registration: Clinicaltrials.gov: NCT05048589.
Keywords: Influenza, Human; Outcome Assessment, Health Care; Pragmatic Clinical Trial; Vaccination.
. 2024 Sep 18:106276.
doi: 10.1016/j.jinf.2024.106276. Online ahead of print. Time of day for vaccination, outcomes, and relative effectiveness of high-dose vs. standard-dose quadrivalent influenza vaccine: a post-hoc analysis of the DANFLU-1 randomized clinical trial
Jacob Christensen 1 , Niklas Dyrby Johansen 1 , Kira Hyldekær Janstrup 1 , Daniel Modin 1 , Kristoffer Grundtvig Skaarup 1 , Joshua Nealon 2 , Sandrine Samson 2 , Matthew Loiacono 3 , Rebecca Harris 4 , Carsten Schade Larsen 5 , Anne Marie Reimer Jensen 1 , Nino Emanuel Landler 1 , Brian L Claggett 6 , Scott D Solomon 7 , Gunnar H Gislason 8 , Lars Køber 9 , Martin J Landray 10 , Pradeesh Sivapalan 11 , Jens Ulrik Stæhr Jensen 11 , Tor Biering-Sørensen 12
Affiliations
- PMID: 39303788
- DOI: 10.1016/j.jinf.2024.106276
Objectives: Morning influenza vaccination enhances antibody response. In this posthoc analysis of the DANFLU-1 trial, we sought to evaluate the association between time of day for vaccination (ToV) and outcomes, and whether ToV modified the relative effectiveness of high-dose (QIV-HD) vs. standard-dose (QIV-SD) quadrivalent influenza vaccine.
Methods: DANFLU-1 was a pragmatic feasibility trial of QIV-HD vs. QIV-SD. Outcomes included hospitalizations and mortality. For subgroup analysis, the population was dichotomized at median ToV into two groups (early and late).
Results: The study population included 12,477 participants. Mean age was 71.7±3.9 years with 5,877 (47.1%) female participants. Median ToV was 11.29AM. Earlier ToV was associated with fewer respiratory hospitalizations independent of vaccine type, which persisted in adjusted analysis (IRR 0.88 per 1-hour decrement (95% CI 0.78- 0.98, p=0.025). No effect modification by continuous or dichotomous ToV was found. In subgroup analysis, effects consistently favored QIV-HD against hospitalizations for pneumonia or influenza (early: IRR 0.30; late: 0.29), all-cause hospitalizations (early: IRR 0.87; late: 0.86), and mortality (early: HR 0.53; late: 0.50).
Conclusion: In this exploratory post-hoc analysis, earlier ToV was associated with fewer respiratory hospitalizations. The relative effectiveness of QIV-HD vs. QIV-SD was not modified by ToV. Further research is needed to confirm findings.
Trial registration: Clinicaltrials.gov: NCT05048589.
Keywords: Influenza, Human; Outcome Assessment, Health Care; Pragmatic Clinical Trial; Vaccination.