Influenza Vaccination Strategy for Patients With Hematologic Malignancy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
High-dose trivalent inactivated influenza vaccine (HD-IIV3)
Biological/VaccineHigh-dose trivalent inactivated influenza vaccine containing 60 µg hemagglutinin per strain (4× standard dose). Single intramuscular injection administered during the influenza season.
MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4)
Biological/VaccineMF59C.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 (SD-IIV3)
Biological/VaccineStandard-dose trivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season. Active comparator.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Standard dose Influenza vaccineActive comparator 1 intervention
Group B: High dose influenza vaccineExperimental treatment 1 intervention
Group C: MF.59 adjuvant influenza vaccineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Seroconversion rate at Day 28 post-vaccination
Proportion of participants achieving ≥4-fold rise in hemagglutinin inhibition (HAI) titer from baseline at Day 28, compared among HD-IIV3, aIIV4, and SD-IIV3 arms
Time frame
Day 28 (±7 days) post-vaccinationSecondary outcomes
1
Other Immunogenicity
1. Humoral Immune Response (Antibody Response) Geometric Mean Titer (GMT): Measured by Hemagglutination Inhibition (HAI) assay. Geometric Mean Fold Rise (GMFR): Ratio of post-vaccination to pre-vaccination HAI titer. Seroprotection Rate: Proportion of participants achieving an HAI titer of ≥ 1:40. 2. Cellular Immune Response T-cell Functionality: Quantification of IFN-γ, TNF-α, and IL-2 expression in CD4+ and CD8+ T cells from peripheral blood mononuclear cells (PBMCs).
Time frame
Day 28 (±7 days), Day 180(±30 days), and Day 365(±30 days) post-vaccinationSponsors and contacts
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Source ClinicalTrials.gov