NCT07485855

Influenza Vaccination Strategy for Patients With Hematologic Malignancy

Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

Patients with hematologic malignancies face a 3-10 times higher risk of influenza infection and a 5-20 times greater rate of severe complications compared to the general population, owing to disease- and treatment-related immunosuppression. Although high-dose and adjuvanted influenza vaccines have been proposed to overcome suboptimal vaccine responses in this population, robust comparative evidence remains lacking - particularly following recent clinical trials which did not demonstrate superiority of adjuvanted vaccine over standard-dose vaccine in terms of antibody response. Critically, T cell-mediated immune responses, which may serve as an independent correlate of protection especially in B cell-depleted patients (e.g., post-CAR-T therapy), have not been comprehensively evaluated in prior trials. This randomized controlled trial aims to compare the immunogenicity of three influenza vaccine formulations - high-dose trivalent inactivated vaccine (HD-IIV3; Efluelda), MF59-adjuvanted quadrivalent inactivated vaccine (aIIV4; Fluad Quadrivalent), and standard-dose trivalent inactivated vaccine (SD-IIV3) - in patients with hematologic malignancies including lymphoma, leukemia, plasma cell disorders, and those undergoing autologous stem cell transplantation or CAR-T cell therapy. Immunogenicity will be assessed by both antibody responses (HAI-based GMT, seroconversion, seroprotection) and cellular immune responses (polyfunctional CD4+ and cytotoxic CD8+ T cells via IFN-γ/TNF-α/IL-2 intracellular cytokine staining of PBMCs) at baseline, Day 28, Day 180, and Day 365.

Conditions

• Hematologic Neoplasms
• Influenza
• Immunogenicity

Interventions

Type	Name	Description
BIOLOGICAL	High-dose trivalent inactivated influenza vaccine (HD-IIV3)	High-dose trivalent inactivated influenza vaccine containing 60 µg hemagglutinin per strain (4× standard dose). Single intramuscular injection administered during the influenza season.
BIOLOGICAL	MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4)	MF59C.1 squalene-based adjuvanted quadrivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season.
BIOLOGICAL	Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)	Standard-dose trivalent inactivated influenza vaccine containing 15 µg hemagglutinin per strain. Single intramuscular injection administered during the influenza season. Active comparator.

Timeline

• Start date: 2025-12-04
• Primary completion: 2027-04-30
• Completion: 2028-04-30
• First posted: 2026-03-20
• Last updated: 2026-03-24

Locations

1 site across 1 country: South Korea