Influenza Vaccination Strategy for Patients With Hematologic Malignancy

NCT07485855 | Recruiting Phase 3

• 2 other identifiers: 2025-1450RS-2025-25468314
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hematologic Neoplasms; Influenza; Immunogenicity

Outcome Measures

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

  Day 28 (±7 days) post-vaccination

Secondary Outcomes (1)

• Other Immunogenicity

  Day 28 (±7 days), Day 180(±30 days), and Day 365(±30 days) post-vaccination

Study Arms (3)

Standard dose Influenza vaccine

ACTIVE COMPARATOR

Standard dose Influenza vaccine

Biological: Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)

High dose influenza vaccine

EXPERIMENTAL

High dose influenza vaccine

Biological: High-dose trivalent inactivated influenza vaccine (HD-IIV3)

MF.59 adjuvant influenza vaccine

EXPERIMENTAL

MF.59 adjuvant influenza vaccine

Biological: MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4)

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.

High dose influenza vaccine

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.

MF.59 adjuvant influenza vaccine

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.

Standard dose Influenza vaccine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (11)

• Hall VG, Smibert OC, Sullivan SG, Lim C, Barr IG, Peck H, Fuge-Larsen P, Demajo J, Klimevski E, Tennakoon S, Saunders NR, Joyce T, Whitechurch A, Khot A, Anderson MA, Trubiano JA, Yong MK, Worth LJ, Spelman T, Slavin MA, Teh BW. Influenza Vaccination Strategies in Patients with Hematologic Cancer. N Engl J Med. 2025 Jan 16;392(3):306-308. doi: 10.1056/NEJMc2406750. No abstract available.

  PMID: 39813653 BACKGROUND

• Silva-Moraes V, Reis LR, Ross TM. Comparative analysis of cellular immune responses to four seasonal inactivated influenza vaccines in younger and older adults. J Immunol. 2026 Feb 9;215(2):vkaf286. doi: 10.1093/jimmun/vkaf286.

  PMID: 41166714 BACKGROUND

• Hall VG, Nguyen THO, Smibert OC, Allen LF, Sullivan SG, Fox A, Carolan L, Wheatley AK, Kent SJ, Gilbertson B, Lim C, Barr IG, Peck H, Fuge-Larsen P, Klimevski E, Tennakoon S, Saunders NR, Joyce T, Whitechurch A, Khot A, Anderson MA, Trubiano JA, Worth LJ, Yong MK, Slavin MA, Kedzierska K, Teh BW. Influenza-Specific T-Cell Responses to Vaccination Are Independent of Underlying Hematological Malignancy: Analysis of a Randomized Influenza Vaccination Trial. J Infect Dis. 2025 Dec 20;232(6):1319-1329. doi: 10.1093/infdis/jiaf297.

  PMID: 40600710 BACKGROUND

• Kinoshita H, Walti CS, Webber K, Pezzella G, Jensen-Wachspress M, Lang H, Shuey K, Boonyaratanakornkit J, Pergam SA, Chu HY, Bollard CM, Keller MD, Hill JA. T Cell Immune Response to Influenza Vaccination When Administered Prior to and Following Autologous Chimeric Antigen Receptor-Modified T Cell Therapy. Transplant Cell Ther. 2025 May;31(5):327-338. doi: 10.1016/j.jtct.2025.02.019. Epub 2025 Mar 1.

  PMID: 40032074 BACKGROUND

• Branagan AR, Duffy E, Gan G, Li F, Foster C, Verma R, Zhang L, Parker TL, Seropian S, Cooper DL, Brandt D, Kortmansky J, Witt D, Ferencz TM, Dhodapkar KM, Dhodapkar MV. Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias. Blood Adv. 2021 Mar 9;5(5):1535-1539. doi: 10.1182/bloodadvances.2020003880.

  PMID: 33683337 BACKGROUND

• Natori Y, Humar A, Lipton J, Kim DD, Ashton P, Hoschler K, Kumar D. A pilot randomized trial of adjuvanted influenza vaccine in adult allogeneic hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2017 Jul;52(7):1016-1021. doi: 10.1038/bmt.2017.24. Epub 2017 Mar 6.

  PMID: 28263288 BACKGROUND

• Halasa NB, Savani BN, Asokan I, Kassim A, Simons R, Summers C, Bourgeois J, Clifton C, Vaughan LA, Lucid C, Wang L, Fonnesbeck C, Jagasia M. Randomized Double-Blind Study of the Safety and Immunogenicity of Standard-Dose Trivalent Inactivated Influenza Vaccine versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Hematopoietic Stem Cell Transplantation Patients. Biol Blood Marrow Transplant. 2016 Mar;22(3):528-35. doi: 10.1016/j.bbmt.2015.12.003. Epub 2015 Dec 17.

  PMID: 26705931 BACKGROUND

• Thomas LD, Batarseh E, Hamdan L, Haddadin Z, Dulek D, Kalams S, Stewart LS, Stahl AL, Rahman H, Amarin JZ, Hayek H, Ison M, Overton ET, Pergam SA, Spieker AJ, Halasa NB; Adult HCT Flu Study. Comparison of Two High-Dose Versus Two Standard-Dose Influenza Vaccines in Adult Allogeneic Hematopoietic Cell Transplant Recipients. Clin Infect Dis. 2023 Dec 15;77(12):1723-1732. doi: 10.1093/cid/ciad458.

  PMID: 39219510 BACKGROUND

• Whitaker JA, Parikh SA, Shanafelt TD, Kay NE, Kennedy RB, Grill DE, Goergen KM, Call TG, Kendarian SS, Ding W, Poland GA. The humoral immune response to high-dose influenza vaccine in persons with monoclonal B-cell lymphocytosis (MBL) and chronic lymphocytic leukemia (CLL). Vaccine. 2021 Feb 12;39(7):1122-1130. doi: 10.1016/j.vaccine.2021.01.001. Epub 2021 Jan 16.

  PMID: 33461835 BACKGROUND

• Teh BW, Leung VKY, Mordant FL, Sullivan SG, Joyce T, Harrison SJ, Khvorov A, Barr IG, Subbarao K, Slavin MA, Worth LJ. A Randomized Trial of Two 2-Dose Influenza Vaccination Strategies for Patients Following Autologous Hematopoietic Stem Cell Transplantation. Clin Infect Dis. 2021 Dec 6;73(11):e4269-e4277. doi: 10.1093/cid/ciaa1711.

  PMID: 33175132 BACKGROUND

• Cowling BJ, Perera RAPM, Valkenburg SA, Leung NHL, Iuliano AD, Tam YH, Wong JHF, Fang VJ, Li APY, So HC, Ip DKM, Azziz-Baumgartner E, Fry AM, Levine MZ, Gangappa S, Sambhara S, Barr IG, Skowronski DM, Peiris JSM, Thompson MG. Comparative Immunogenicity of Several Enhanced Influenza Vaccine Options for Older Adults: A Randomized, Controlled Trial. Clin Infect Dis. 2020 Oct 23;71(7):1704-1714. doi: 10.1093/cid/ciz1034.

  PMID: 31828291 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Influenza, Human

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Sung-Han Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Yun Lim, MD, PhD

CONTACT

+82-10-4120-3816; soyun_lim@amc.seoul.kr

Sung-Han Kim, MD, PhD

CONTACT

+82-2-3010-3305; shkimmd@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)