Influenza Vaccination Strategy for Patients With Hematologic Malignancy

Sponsor
Asan Medical Center
Study ID
NCT07485855
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hematologic Neoplasms
  • Immunogenicity
  • Influenza

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-dose trivalent inactivated influenza vaccine (HD-IIV3) — BIOLOGICAL
    High-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
    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 (SD-IIV3) — BIOLOGICAL
    Standard-dose trivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season. Active comparator.

Study Details

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

Key Dates

First listed
Mar 20, 2026
Start date
Dec 4, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Standard dose Influenza vaccine
    Standard dose Influenza vaccine
  • Experimental: High dose influenza vaccine
    High dose influenza vaccine
  • Experimental: MF.59 adjuvant influenza vaccine
    MF.59 adjuvant influenza vaccine

Primary Outcome Measure

Seroconversion rate at Day 28 post-vaccination [ Time Frame: Day 28 (±7 days) post-vaccination ]

Central Contacts

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