Influenza Vaccination Strategy for Patients With Hematologic Malignancy
Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies
Asan Medical Center
60 participants
Dec 4, 2025
INTERVENTIONAL
Conditions
Summary
This randomized controlled trial evaluates and compares the immunogenicity of three different influenza vaccine formulations: high-dose trivalent (HD-IIV3), MF59-adjuvanted quadrivalent (aIIV4), and standard-dose trivalent (SD-IIV3) vaccines. The study population consists of patients with hematologic malignancies, including those undergoing autologous stem cell transplantation or CAR-T cell therapy. The primary goal is to identify which vaccine strategy elicits the most robust antibody and T cell-mediated immune responses in this severely immunocompromised population
Eligibility
Inclusion Criteria3
- Adults aged 19 years or older
- Confirmed diagnosis of hematologic malignancy, including:
- non-Hodgkin lymphoma, Hodgkin lymphoma, acute leukemia, chronic leukemia, or plasma cell disorders
Exclusion Criteria5
- Difficulty with repeated venipuncture or blood sampling (e.g., poor vascular access or bleeding tendency)
- Cognitive or psychiatric impairment precluding understanding of or cooperation with study procedures
- Known hypersensitivity to influenza vaccine components
- Influenza vaccination within the preceding 6 months
- Any other condition deemed clinically inappropriate for study participation at investigator discretion
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Interventions
High-dose trivalent inactivated influenza vaccine containing 60 µg hemagglutinin per strain (4× standard dose). Single intramuscular injection administered during the influenza season.
MF59C.1 squalene-based adjuvanted quadrivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season.
Standard-dose trivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season. Active comparator.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07485855