Influenza Vaccination Strategy for Patients With Hematologic Malignancy

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

Timeline

Start

2025-12-04

Primary completion

2027-04-30

Completion

2028-04-30

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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