Clinical trial · Interventional
Influenza Vaccination Strategy for Patients With Hematologic Malignancy
Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies
NCT07485855CI-TRIAL-00124953(HEM-FLU)recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Immunogenicity | — | UNRESOLVED | — |
| Influenza | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose trivalent inactivated influenza vaccine (HD-IIV3) | Biological | — | UNRESOLVED |
| MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4) | Biological | — | UNRESOLVED |
| Standard-dose trivalent inactivated influenza vaccine (SD-IIV3) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard dose Influenza vaccine
- description
- Standard dose Influenza vaccine
- interventionNames
- Biological: Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)
- type
- EXPERIMENTAL
- label
- High dose influenza vaccine
- description
- High dose influenza vaccine
- interventionNames
- Biological: High-dose trivalent inactivated influenza vaccine (HD-IIV3)
- type
- EXPERIMENTAL
- label
- MF.59 adjuvant influenza vaccine
- description
- MF.59 adjuvant influenza vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (11)
- BACKGROUNDHall 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
- BACKGROUNDSilva-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
- BACKGROUNDHall 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
- BACKGROUNDKinoshita 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
- BACKGROUNDBranagan 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