Page 110 - Ebook-Book JCMS 2025

A Comparative Evaluation of the Immune Response and
Safety Profile of High-Dose Versus Double Standard-
Dose Quadrivalent Inactivated Influenza Vaccine in Adult
Kidney Transplant Recipients: Findings from the HANUMAN
Randomized Controlled Trial
Thanachote Arayanumas1, Surasak Kantachuvesiri1, Sarinya Boongird1, Sasisopin Kiertiburanakul1
,
Jackrapong Bruminhent1*, Kobporn Boonnak2
1 Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
2 Department of Immunology, Faculty of Medicine, Siriraj Hospital, Mahidol University
*Corresponding Author E-mail: jackrapong.brm@mahidol.ac.th
Background: Abstract
Kidney transplant (KT) recipients face a heightened risk of severe influenza and often exhibit
suboptimal responses to standard-dose vaccines. Strategies such as high-dose (HD) and
double standard-dose (DD) quadrivalent inactivated influenza vaccines (QIIV) have been
explored to enhance immunogenicity. However, the necessity for multiple visits in DD
regimens may impact adherence.
Methods: Results: In this open-label, randomized controlled trial (June–December 2023), we evaluated the
immunogenicity and safety of a single-dose HD QIIV (Effluelda, Sanofi) compared to a
two-dose DD QIIV regimen (Fluarix Tetra, Sanofi) in adult KT recipients. Hemagglutination
inhibition assays assessed strain-specific antibody responses at baseline and four weeks
post-vaccination. Adverse events were systematically recorded.
Eighty-four KT recipients were randomized equally to receive either HD or DD QIIV. The
mean age was 46 years, with 59.5% male and 60.7% receiving kidneys from deceased
donors. Most were on immunosuppressive therapy, including mycophenolate mofetil
(65.5%), tacrolimus (77.1%), and prednisolone (100%). Seroconversion (SC) to at least
one influenza strain was significantly higher in the HD group (95.2%) than in the DD group
(69%) (P = 0.002). HD recipients exhibited higher SC rates for individual strains, with a
statistically significant advantage for B/Phuket (P = 0.049). Multivariate analysis identified
HD QIIV (OR 17.59) and vaccination beyond one year post-KT (OR 34.76) as independent
predictors of improved SC. Notably, HD QIIV was associated with fewer local pain (4.8% vs.
19%) and muscle ache (4.8% vs. 9.5%) reports.
Conclusion: In adult KT recipients, HD QIIV induced stronger immune responses with fewer side effects
than a DD QIIV regimen, supporting its use as a more effective single-visit vaccination
strategy in this population.
108 Joint Conference in Medical Sciences 2025